Vision and Balance Changes After Bilateral Implantation of Toric Versus Non-Toric Intraocular Lenses in Cataract Patients With Astigmatism
Phase: NA
Conditions: Cataract Bilateral, Astigmatism Bilateral
Sponsor: University of Plymouth

 
 
 
Vision and balance changes after bilateral implantation of Toric IOLs 
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Full study title: 
Vision and balance changes after bilateral implantation of Toric versus 
non-Toric intraocular lenses in Cataract patients with astigmatism 
 
Short study title: 
Vision and balance changes after bilateral implantation of Toric IOLs 
 
 
This protocol has regard to the HRA guidance and order of content 
 
 
 
RESEARCH REFERENCE NUMBERS 
IRAS project ID: 286913 
R&D Reference No: 21/OPH/606 
Clinicaltrials.gov number: pending 
 
Version: Toric IOL 1.2 (1st September 2022) 
 
OTHER RESEARCH REFERENCE NUMBERS 
PEOS ID: 2669 
UOP Grant number: RR2 04499/101 
 
SPONSOR  
Study Sponsor: University Hospitals Plymouth NHS Trust 
Study funder: Carl Zeiss AG 
 

 
 
 
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KEY TRIAL CONTACTS 
Chief Investigator 
Professor Phillip Buckhurst 
Room SF17, School of Health Professions,  
Peninsula Allied Health Centre, 
 University of Plymouth, PL6 8BH 
Phone: +44 1752 588884 
phillip.buckhurst@plymouth.ac.uk 
Principal investigator 
Professor Nabil Habib 
Consultant Ophthalmologist,  
Royal Eye Infirmary, Derriford Hospital 
Phone: +44 (0)1752 439353 
nabil.habib@nhs.net 
Sponsor 
University Hospitals Plymouth NHS Trust 
Dr Chris Rollinson (representative) 
Research Governance Manager 
The Research Office  
Level 2 MSCP, Bircham Park Offices 
1 Roscoff Rise, Derriford  
Plymouth, PL6 5FP 
+44 1752 432842 
Plh-tr.RD-Office@nhs.net 
PhD student and Trial Co-ordinator 
Ms Sherrie Choy 
Chartered Physiotherapist, PhD student 
Room FF01, School of Health Professions,  
Peninsula Allied Health Centre, 
 University of Plymouth, PL6 8BH 
Phone: 07903692005 
sherrie.choy@plymouth.ac.uk  
Co-investigators 
Dr Catriona MacLennan (Lecturer) 
Department of Vision Sciences 
University of Glasgow Caledonian University, G4 0BA 
Phone: +44 1412731261 
Catriona.maclennan@gcu.ac.uk 
 

 
 
 
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Dr Hetal Buckhurst (Associate Professor) 
Department of Optometry, School of Health Professions,  
University of Plymouth 
Phone: +44 1752 588886 
Hetal.buckhurst@plymouth.ac.uk 
Prof Gary Shum 
School of Sport, Health and Wellbeing 
Plymouth Marjon University 
Phone: +44 1752 636700 
Gshum@marjon.ac.uk 
Funder(s) 
Carl Zeiss Meditec AG 
En Gyung Kim (Product Manager Refractive IOL ) 
Carl Zeiss Meditec AG 
Max-Dohrn-Str. 8-10 
10589 Berlin, Germany 
Phone: +49 30 8540 01 214 
Mobile: +49 151 20015278 
engyung.kim@zeiss.com 
www.zeiss.com/med 
Key Protocol Contributors 
Ms Sherrie Choy 
Chartered Physiotherapist, PhD student 
Phone: +44 1752 588800 
sherrie.choy@plymouth.ac.uk 
Statistician 
Prof Victoria Allgar 
Professor of Medical Statistics and Director of Peninsula Clinical Trials 
Unit 
Peninsula Medical School, Faculty of Health 
University of Plymouth 
+44 1752764437 
medstats@plymouth.ac.uk 
 
 
 

 
 
 
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i. 
LIST of CONTENTS 
 
KEY TRIAL CONTACTS ............................................................................................................................. 2 
i. LIST of CONTENTS ............................................................................................................................... 4 
ii. LIST OF ABBREVIATIONS ..................................................................................................................... 5 
iii. TRIAL SUMMARY................................................................................................................................... 7 
iv. FUNDING AND SUPPORT IN KIND ...................................................................................................... 8 
v. ROLE OF TRIAL SPONSOR AND FUNDER .......................................................................................... 8 
vi. ROLES AND RESPONSIBILITIES OF TRIAL MANAGEMENT COMMITEES/GROUPS & 
INDIVIDUALS ......................................................................................................................................... 8 
vii. STUDY CONTRIBUTORS ..................................................................................................................... 9 
viii. KEY WORDS: ..................................................................................................................................... 10 
ix. TRIAL FLOW CHART ........................................................................................................................... 11 
1. BACKGROUND .................................................................................................................................... 12 
2. RATIONALE ......................................................................................................................................... 13 
3. OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS ................................................................ 17 
4. TRIAL DESIGN ..................................................................................................................................... 19 
5. TRIAL SETTING ................................................................................................................................... 20 
6. PARTICIPANT ELIGIBILITY CRITERIA .............................................................................................. 20 
7. TRIAL PROCEDURES ......................................................................................................................... 21 
8. TRIAL TREATMENTS ........................................................................................................................... 29 
9. SAFTEY REPORTING .......................................................................................................................... 32 
10. STATISTICS AND DATA ANALYSIS .................................................................................................. 37 
11. DATA MANAGEMENT ........................................................................................................................ 43 
12. MONITORING, AUDIT & INSPECTION .............................................................................................. 44 
13. ETHICAL AND REGULATORY CONSIDERATIONS ......................................................................... 45 
14. DISSEMINIATION POLICY ................................................................................................................. 49 
15. REFERENCES .................................................................................................................................... 51 
16. APPENDICIES .................................................................................................................................... 52 
 
 
 

 
 
 
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ii. LIST OF ABBREVIATIONS 
Define all unusual or ‘technical’ terms related to the trial.  Add or delete as appropriate to your trial.  
Maintain alphabetical order for ease of reference. 
AE 
Adverse Event 
AR 
Adverse Reaction 
CA 
Competent Authority 
CAT-PROM 
Cataract surgery patient-reported outcome measures 
CI 
Chief Investigator 
CRF 
Case Report Form 
FES 
Fall Efficacy Scale 
GCP 
Good Clinical Practice 
GMP 
Good Manufacturing Practice  
IB 
Investigator Brochure 
ICF 
Informed Consent Form 
IOLs 
Intraocular lens 
IPR 
Intellectual Property Right 
ISF 
Investigator Site File (This forms part of the TMF) 
ISRCTN 
International Standard Randomised Controlled Trials Number 
LRI 
Limbic relaxing incision 
MA 
Marketing Authorisation 
MHRA 
Medicines and Healthcare products Regulatory Agency 
MS 
Member State 
NHS R&D 
National Health Service Research & Development  
NICE 
The National Institute for Health and Care Excellence 
NIHR 
National Institute for Health Research 
NIMP 
Non-Investigational Medicinal Product 
PAHC 
Peninsula Allied Health Centre 
PI 
Principal Investigator 
PIC 
Participant Identification Centre 
PIS 
Participant Information Sheet 
QA 
Quality Assurance 
QC 
Quality Control 
QP 
Qualified Person  
RCT 
Randomised Control Trial 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SAR 
Serious Adverse Reaction 
SDV 
Source Data Verification 
SOP 
Standard Operating Procedure  
SSI 
Site Specific Information 

 
 
 
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SUSAR 
Suspected Unexpected Serious Adverse Reaction  
TMF 
Trial Master File 
TMG 
Trial Management Group 
TSC 
Trial Steering Committee 
TUG  
Timed Up and Go Test 
UHP 
University Hospitals Plymouth NHS Trust 
UOP 
University of Plymouth 
 
 

 
 
 
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iii. TRIAL SUMMARY 
Trial Title 
Vision and balance changes after bilateral implantation of Toric versus non-Toric 
intraocular lenses in Cataract patients with astigmatism 
Internal ref. no.  
(or short title) 
Vision and balance changes after bilateral implantation of Toric IOLs 
Clinical Phase  
Pre and post operation comparison 
Trial Design 
Randomised controlled trial 
Trial Participants 
Ambulatory adult aged over 50 years with bilateral cataract patients and astigmatism 
>1.0D awaiting intraocular lens replacement surgery  
Planned Sample Size 
140 participants 
Treatment duration 
Up to 12 months after first eye surgery 
Follow up duration 
12 months after second eye surgery  
Planned Trial Period 
3 years 
 
Objectives 
Outcome Measures 
Primary 
• 
Dynamic 
balance 
in 
functional activities 
• 
Centre of mass and head movement by 
accelerometer in crossing obstacles, 
turning and stair walking 
Secondary 
• 
Eye tracking characteristics 
• 
Visual function 
• 
Risk of fall 
• 
Vision related quality of life 
• 
Area of interest (heatmap) and gaze 
duration by eye tracking (Tobii pro2) 
during level ground obstacle crossing 
and stair walking 
• 
Duration of Timed up and go test Visual 
acuity 
• 
IOL rotation  
• 
Fall efficacy scale and fear of falling 
• 
CAT-PROM 5 questionnaire 
Investigational 
Medicinal Product(s) 
Monofocal Toric and non-Toric intraocular lens 
Formulation, Dose, 
Route of 
Administration 
Artificial intraocular lens implantation during cataract correction surgery 
 
 
 

 
 
 
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iv. FUNDING AND SUPPORT IN KIND 
FUNDER(S) 
FINANCIAL AND NON FINANCIALSUPPORT GIVEN 
Carl Zeiss Meditec AG 
En Gyung Kim (Product Manager Refractive IOL) 
Carl Zeiss Meditec AG  
Max-Dohrn-Str. 8-10  
10589 Berlin, Germany  
Phone: +49 30 8540 01 214  
Mobile: +49 151 20015278  
engyung.kim@zeiss.com  
www.zeiss.com/med  
1. All Zeiss Toric and non-Toric IOLs needed for this 
project (bilateral eyes of 140 participants plus 
spare)  
2. Research grant to University of Plymouth grant 
number: RR2 04499/101 for full-time PhD 
studentship, participant travel subsidy and 
research conference subsidy 
 
v. ROLE OF TRIAL SPONSOR AND FUNDER 
Carl Zeiss Meditec AG is the trial funder.  It funds the study by providing both the Toric and non-Toric 
monofocal intraocular lenses needed in the cataract correction surgery for all participants in this study 
and a research grant to the University of Plymouth covering a full-time PhD studentship, travel subsidy 
for patients’ study visits and related expenses required for presentation of this research in conferences.  
University Hospitals Plymouth NHS Trust (UHP) is the sponsor.  The Research and Development (R&D) 
Office of UHP provides support for research approval process and implementation to ensure it is 
compliant to the Health Research Authority (HRA) guidelines.  The Consultant Ophthalmologist Prof. 
Nabil Habib of UHP provides collaboration as Principal Investigator to lead and provide intraocular lens 
replacement surgery to selected Cataract patients, as well as review of data analysis and report of 
result. UHP also provides research support with input from the R&D team to support the 
implementation of this project. 
 
vi. ROLES AND RESPONSIBILITIES OF TRIAL MANAGEMENT 
COMMITEES/GROUPS & INDIVIDUALS 
The University of Plymouth (UoP) is the provider of the PhD studentship and the related training.  The 
supervisory team holds weekly meetings with the PhD student Ms. Choy to monitor the study progress 
and to discuss any issues arise.  The PhD student, the supervisory team, PI and study Sponsor also has 
regular meeting to update progress of the study and to discuss any issue that impact on the research 

 
 
 
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project.  The study is also required to comply with the UoP Research Ethics Policy and the Code of Good 
Research Practice and Research Data Policy 
(https://www.plymouth.ac.uk/research/governance/research-ethics-policy).  
Ethical approval is not required by the University, but this study is also registered on the Plymouth 
Ethics Online System of University of Plymouth for record purpose. 
 
vii. STUDY CONTRIBUTORS 
Prof Phillip Buckhurst of UoP is the Chief Investigator (CI) of this study.  He is a chartered optometrist 
and takes primary responsibility for the conduct of this research project from research design, the three 
study visits at the University of Plymouth (PAHC building) and result generation.  He will act as the 
contact person for University of Plymouth, overseeing the management and research conduct 
throughout the trial period, and coordinating the personnel with sponsor and co-investigators.  He is 
also responsible for the overall conduct of the research project to meet the standard as set in the UK 
Policy Framework of Health and Social Care Research.  
Prof. Habib is the Principal Investigator (PI) and the clinical lead of this study.  He is the Consultant 
Ophthalmologist at Royal Eye Infirmary (REI) of UHP and has responsibility for the conduct of the 
research at UHP.  He will supervise the participant recruitment, screening for inclusion/exclusion 
criteria and the implementation of the intervention with his clinical team at the REI.  He will coordinate 
with the sponsor (UHP) to ensure this project meet the required regulatory requirements.  He and his 
ophthalmologist team are responsible for the cataract clinic pathway and post-operation care of the 
participants recruited for this study.  
Dr Catriona MacLennan of Glasgow Caledonian University, Prof Gary Shum of Plymouth Marjon 
University and Dr Hetal Buckhurst of University of Plymouth, are co-investigators of this research trial.  
They co-supervise the PhD student; provide consultancy for the research idea and implementation 
including trial design, liaison with hospital and Ophthalmologists, research training provision, research 
implementation, data analysis, manuscript writing and dissemination of results in conference and peer 
reviewed journals. 
This trial protocol is prepared by Ms Sherrie Choy who is a PhD student at the University of Plymouth 
and chief coordinator for the study.  She is responsible for preparing documents to meet the required 

 
 
 
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standard for the approval ethics and the HRA.  She is also responsible for patient recruitment, carrying 
out outcome measures, data analysis and management, writing up of major findings of results and 
overall study coordination. 
 
viii. KEY 
WORDS: 
cataracts, intraocular lens, astigmatism, Toric intraocular lens, Monofocal 
intraocular lens, dynamic stability, quality of life, eye tracking, visual 
functions, randomised controlled trial 
 
 
 

 
 
 
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ix. TRIAL FLOW CHART 
 
 
 
 
 
 

 
 
 
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1. BACKGROUND 
Cataracts are the most common cause of low vision and blindness in the world (Brian and Taylor, 2001).  
Cataracts occur when the crystalline lens becomes cloudy preventing light from reaching the retina and 
so resulting in poor vision.  Cataract is highly treatable and the surgery involves removing the cloudy 
crystalline lens and replacing it with a clear artificial plastic lens (made of acrylic) called an Intraocular 
lens (IOLs) (Foster, 2001).  
Around one fifth of people attending for cataract surgery have astigmatism (Swampillai et al., 2020). 
Astigmatism refers to the imperfection in the curvature of the cornea, the clear and dome-shaped 
covering in front of the eye.  An eye with severe astigmatism is oval (like a rugby ball) instead of round 
like a football.  This oval shape reduces vision and make vision blurry all over, not just close-up, or far 
away. While most astigmatism orientated with the steep curve vertically, for some, it can be horizontal 
(the rugby ball on its side) or more rarely, obliquely positioned (neither horizontal nor vertical).  Degree 
of astigmatism is measured in dioptre (D).  A perfect eye has zero dioptre. Most people can have 
between 0.5-0.75 D and people with 1.5D or more typically need to wear contact lenses or eyeglasses 
for clear vision. 
Conventional non-Toric monofocal IOLs is the most common implants used in cataract replacement 
surgery. They stay focused at one fixed distance and when chosen to correct distance vision error such 
as short-sightedness, reading glasses may be needed to see thing close-up. Also, these lenses do not 
correct astigmatism. In most NHS hospitals such as in UHP, astigmatism often is left untreated during 
the cataract replacement surgery. 
With the advance of IOLs, a modern design of intraocular lenses called Toric IOLs, can correct the 
astigmatism at the time of cataract replacement surgery.  They provide superior correction of 
astigmatism than other surgical procedures and are known to reduce the need for the patient to wear 
spectacles after the surgery.  Although Toric IOLs may be regarded as “premium IOLs” due to higher 
cost than conventional Monofocal IOLs, a cost-effectiveness analysis based on hypothetical model in 
four European countries noted that Toric IOLs were a cost-saving alternative to conventional Monofocal 
lenses (Laurendeau et al., 2009).  The additional vision improvement by correcting astigmatism, 
especially in older population not only reduce spectacle dependency, but it may also have positive 

 
 
 
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impact on balance during daily mobility, reduce fall risk and improve overall quality of life.  The purpose 
of this study is to compare the changes in dynamic balance and vision functions during daily activities 
among patients with cataract replacement with Toric monofocal IOLs versus those with non-Toric 
monofocal IOLs. 
2. RATIONALE  
Cataract is one of the major causes of visual impairment and blindness in the aging population.  In UK, 
cataract alone accounts for over a third of the cases of vision impairment in those over 75 years.  The 
Royal College of Ophthalmologists estimated a growth in prevalent cataracts by 43-57% between 2015 
and 2035, causing around 50% increase in the expected number of cataract operations over the next 
20 years.  During cataract correction surgery, artificial lenses, otherwise known as intraocular lenses 
(IOLs), are used to replace the natural crystalline lens within the eye.  By selecting IOLs of appropriate 
lens power, the pre-existing refractive error of the eye such as short-sightedness can be corrected 
during the IOLs implantation (Asbell et al, 2005).  Routine pre-operation assessment by 
ophthalmologists usually takes place 2-4 week before the cataract surgery.  The ophthalmologist will 
select the appropriate IOLs by measuring of the axial length of the eye and the curvature of the cornea- 
the front clear covering of the eye.  Implantation of the standard monofocal IOLs can only correct 
spherical refractive errors (near or far eyesight).  Any preoperative astigmatism- imperfection of cornea 
curvature, can still affect the visual acuity and spectacle dependence after the operation.  
Astigmatism is measured in the unit called dioptres (D).  People with 1.5D or more usually need to wear 
contact lenses or spectacles for clear vision.  Around 19-22% of the total population has over 1.50DC 
of corneal astigmatism at the time of cataract surgery (Swampillai et al., 2020).  A UK study of 1230 
eyes in an NHS cataract clinic even reported about 40% of the patients attending routine cataract 
surgery had more than 1.00D astigmatism (Khan and Muhtaseb, 2011).  It is estimated that patients 
are 34 times more likely to use spectacles per dioptre of astigmatic error in the better eye (Wilkins et 
al., 2009).  Uncorrected astigmatism not only increases spectacle dependence, even of relatively small 
amount, it can also result in reduction of visual performance (Read et al., 2014).  Reduced vision has 
been shown to link with poor balance or mobility (Lord, 2006) (Lord et al., 2010) (Black and Wood, 
2005).  Oblique astigmatism (where the principal meridians are not orientated vertically or horizontally) 
also proved to affect balance and alter foot placement on steps (Johnson et al., 2013).  This could then 

 
 
 
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increase the risk of falls and adversely affects the overall economic costs of the cataract surgery and 
healthcare.  Full correction of refractive error including astigmatism may have greater impact on 
everyday life than previously thought. 
In the UK, almost all patients undergoing cataract surgery by the NHS are given monofocal intraocular 
lenses (IOLs) whether they have astigmatism or not.  The National Institute for Health and Care 
Excellence (NICE) adult cataract management guideline 2017 recommended monofocal IOLs to be used 
for cataract surgery and only specified not to offer multifocal intraocular lenses for people having 
cataract surgery (in the NHS).  Multifocal IOLs have areas with different focusing power which allows 
near and distant objects to be seen without the need for spectacles.  On the evidence of effectiveness, 
NICE commented that multifocal IOLs “can provide good near and distance vision without the need for 
spectacles, but this is at the expense of a variety of potential visual disturbances.”  Another systematic 
review also noted that there was no difference in distance vision between multifocal and monofocal 
IOLs; but multifocal IOLs had significantly worse results for glare and halos (Khandelwal et al., 2019).  
Therefore, Monofocal IOLs are the standard IOLs used in NHS.  However, there are no 
recommendations around lens design and material for further consideration.  
Toric IOLs, a modern design of intraocular lenses, can provide predictable and precise correction of 
astigmatism with improvement in vision without spectacles for cataract patients (Kessel et al., 2016).  
However, prices for Toric IOLs are higher and buying larger volume of the same standard monofocal 
IOLs is often more economical for the NHS.  Therefore, Toric IOLs are not often offered in routine 
cataract surgery.  Although the latest NICE cataract pathways 2021 have added a remark “Please note: 
the recommendations around lens design and material have been removed to allow for further 
consideration,” to give surgeon or local NHS Clinical Commission Group (CCG) more freedom to decide 
on the types of IOLS provision, but there is still insufficient evidence for consistent patient selection 
criteria.  To date, no study has explored the additional effect of correcting astigmatism at the time of 
cataract surgery, on lifestyle activities and mobility.  The purpose of this study is to evaluate the 
benefits of correcting astigmatism during cataract surgery on an individual's dynamic stability, visual 
functions, fear of falls and quality of life using modern design Toric IOLs when compared to 
conventional non-Toric IOLs.  The results can provide a more holistic comparison of the two Monofocal 
IOLs and act as evidence to inform patient selection criteria for Toric IOLs.  

 
 
 
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2.1 
Assessment and management of risk 
This study has no higher risk than the risk of standard medical care. However, the study will be 
considered medium risk: involving an invasive interventional procedure with a low-risk patient 
population. 
 
Risks 
For Toric IOLs to correct astigmatism, they need to be placed specifically with reference to the steepest 
meridian of the eye.  All IOLs can rotate, but rotation of Toric IOLs can affect its astigmatism correction 
effect.  Small rotations do not affect the astigmatic power, but larger rotations will reduce the 
astigmatism correcting effect.  If the IOL is rotated 30 degrees, the astigmatism correcting effect is 
eliminated (Visser et al., 2013).  In approximately 1% of patients, the Toric lens rotates significantly 
reducing the level of astigmatism that is corrected by the Toric lens.  If this is the case, and the 
participant is unhappy with their visual outcome, the surgeon will discuss the possibility of a secondary 
procedure to reposition the lens.  The surgeon will discuss the risks of the repositioning procedure with 
the participant to determine if the benefits outweigh the risks.  It is important to note that this 
repositioning (to correct any unwanted astigmatism) is only possible with Toric lenses, with standard 
IOLs unwanted astigmatism will not be corrected.  Even with significant Toric IOLs rotation, additional 
surgery is generally not required as by removing the cataract, the rotated Toric IOLs still provide 
significant improvement in vision and the remaining astigmatism can be corrected with spectacles.  
The mobility assessment involves walking over obstacles, turning, going up and down stairs. The 
participants will have three small portable motion sensors placed on their neck and lower back and will 
be asked to wear a pair of eye tracking glasses during the mobility tasks.  There is a very low risk of falls, 
similar as during any normal activities of daily living.  The risk will be minimal as all assessment will be 
carried out under the supervision of an experienced physiotherapist.  Also, the assessment venues are 
part of the University campus which is regularly controlled to maintain environmental safety and has 
provision of first aid equipment.  A patient and public involvement discussion has been conducted 
which covered discussion about assessments and the research design.  All participants were supportive 
about the research idea and felt the research could raise awareness of available choice of IOLs.  
Participants were asked about the practicality of the research and felt it would be better to have all 
assessments done in one site.  The assessments were to be conducted at Marjon Biomechanics Lab and 

 
 
 
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Optometry Lab at PAHC building.  This is now changed to the Biomechanics Laboratory at PACH building.  
There was also discussion about mobility assessments and participants were asked if they felt the tasks 
were too difficult, risky of fall or too much.  All participants felt the mobility task involved were low 
level and not complicated.  They were told that during the mobility assessment, the participant would 
be required to wear eye tracking glasses and have three movement sensors placed on the body.  They 
felt it was small and light weight and reported no concerns about the additional sensor or glasses.  
To assess the eyes comprehensively and take photos, pupil dilating eye drops such as 0.5-1% 
Tropicamide will be used to dilate the patients’ pupils for examination of the back of the eyes.  These 
drops are routinely used in optometry and hospital clinics without need for prescription and all 
precautions will be taken before administration.  The CI, Prof Phillip Buckhurst and co-investigator, Dr 
Hetal Buckhurst are registered Optometrist and will carry out this procedure during the study visit at 
the PAHC.  Dilation eye drops may cause blurring of vision and increase sensitivity to bright light.  Some 
people may also experience temporary stinging and dry mouth.  The effects of the drops normally last 
between two and four hours but can be up to six hours.  All patients will be reminded on the PIS and by 
email or telephone contact before the study visits that they must not drive for the appointment and 
must use alternative means of travel such as taking public transport or ask friend and family to drop 
them off and collect.  They will be advised not to drive or operate heavy machinery until their sight 
returns to normal and their eyes are comfortable. They will also be advised to wear sunglasses to help 
reduce light sensitivity after the eyedrop. 
As three additional visits are required for the study, there is an increase in number of appointments, 
but any travel expenses will be reimbursed, and the patients will also have additional care and 
screening.  
As with all studies, there is a very small risk of breach in confidentiality and failure to maintain data 
securely.  Identifiable patient information, in addition to pseudonymised data will be stored at both UHP 
and UoP, and will be transferred between each site.  All data collected will be kept and transferred securely.  
Benefits 
Participating in this study may allow patients to receive specialised Toric IOLs which are not routinely given 
in NHS cataract surgery.  As a result of the additional study visit, the participants will also have additional 
care and screening for both vision and mobility. The extra study visit after the surgery provides additional 

 
 
 
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follow up opportunity and if the investigators of this study find that you have a rotated lens, then they will 
be able to advise on whether additional treatment would be beneficial for the patients. 
This is a new study to explore the benefit of full vision correction during cataract surgery on vision 
characteristic and dynamic balance in functional activities for fall risk management.  The study can improve 
the understanding of visual impact on functional biomechanics and will provide evidence to inform fall risk 
management from vision perspective.  Fall risk improvement is not currently a considering factor for IOLs 
selection in Cataract management, but this study may provide the needed evidence for better vision and 
fall management among elderly. 
3. OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS 
3.1 
Primary objective 
The objective of the study is to compare the effects of Toric intraocular lens versus Monofocal 
intraocular lens replacement on dynamic stability among cataract patients with astigmatism using a 
randomised controlled trial. 
It is hypothesized that Toric intraocular lens will have additional correction of astigmatism after the 
cataract surgery resulting in and better outcomes in dynamic stability and higher chance of “spectacle-
free”. 
There are two arms of the trial: Monofocal Toric intraocular lens versus Monofocal non-Toric 
intraocular lens 
The research question is based on the PICOT criteria: 
P Population 
Cataract patient with astigmatism >1.0DD awaiting intraocular lens 
replacement surgery 
I Intervention 
Monofocal Toric intraocular lens 
C Comparison group 
Monofocal non-Toric intraocular lens 
O Outcome of interest 
Primary- Dynamic stability will be measured by motion sensor during functional 
movements (crossing obstacles, turning and stair walking) 
Secondary- Eye tracking characteristics, visual function, risk of fall, vision 
specific quality of life questionnaire and Toric IOL rotation. 
T Time 
Before operation (T1) and 3-6 months after each eye operation (T2, T3) 
 

 
 
 
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3.2 
Secondary objectives 
The second objective is to compare the effect of Toric versus Non-Toric monofocal intraocular lenses 
implantation on eye tracking characteristics, visual function, intraocular lens orientation, risk of falls 
and vision related quality of life. 
 
3.3 
Outcome measures/endpoints 
Sample size: 
140 participants will be recruited from patients undergoing cataract surgery at the Royal Eye Infirmary 
of the University Plymouth Hospitals NHS Trust over a three-year period. 
 
Sample size calculation: 
Sample size test calculation was carried out with the G*Power 3.1 program (Faul et al., 2007) for 
comparison of the main outcome measure of dynamic balance (between IOL design) using mixed 
ANOVA (repeated measures, between factor being the type of IOL).  
Based on of the result of dynamic balance measurement in a previous study (Mancini et al., 2011), an 
estimated medium effect size (0.25) will be used.  With a power of 85% and level of significance (p) set 
at 0.05 and effect size of 0.25, 55 participants will be required in each group (Standard non-Toric vs 
Toric IOLs).  Assuming a 20% drop out rate, to secure 55 participants in each group, 70 participants will 
therefore be recruited in each group. For two groups of participants (Toric versus non-Toric), a total of 
140 participants will be recruited. 
3.4 
Primary endpoint/outcome 
Dynamic stability during functional activities which will be assessed by tracing centre of mass and head 
tilting using wireless motion sensors and eye tracker.  The outcome measures of dynamic stability 
include the angular position, velocity and acceleration of the sensors. 
3.5 
Secondary endpoints/outcomes 
1. The eye tracking characteristics (gaze duration, area of interest by gaze pattern and its percentage 
duration gaze time). 

 
 
 
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2. IOL rotation by measuring degrees of rotation from intended position and degrees rotation from 
steepest meridian with digital slit lamp and IOL tilt and decentration using Pentacam4.  This will be part 
of the routine eye assessment for post cataract surgery with Toric IOL. 
3. Visual acuity which is also part of routine eye assessment for all post cataract surgery patients. 
4. Fear of falling and fall efficacy scale via questionnaire. 
5. Cataract specific quality of life questionnaire (CAT-PROM 5) 
 
3.6  
Table of endpoints/outcomes 
Objectives 
Outcome Measures  
Timepoint(s) of evaluation of this 
outcome measure (if applicable) 
Primary Objective 
To compare dynamic stability in 
cataract patients with Toric versus 
non-Toric IOLs 
Dynamic stability: 
- movement of centre of mass and 
head tilting using wireless motion 
sensors. 
Three timepoints: 
1. pre-operation study visit and  
2. post-operation study visit (3-6 
months after first eye surgery). 
3. post-operation study visit (3-6 
months 
after 
second 
eye 
surgery). 
Second Objectives 
To 
compare 
eye 
tracking 
characteristics, visual functions, risk 
of falls and quality of life in cataract 
patients with Toric versus non-Toric 
IOLs 
Eye tracking characteristics: 
-area of interest by gaze pattern 
-Gaze duration on area of interest 
Vision 
function 
include 
visual 
acuity, 
IOL rotation by degrees of rotation 
from intended position and degree 
rotation from the steepest meridian 
using special optometry equipment 
to look at the front of the eye 
(digital slit lamp and Pentacam) 
Risk of fall will be measured by fear 
of falling and fall efficacy scale 
questionnaires.  
Vision related quality of life will be 
measured 
by 
CAT-PROM5 
questionnaire. 
Three timepoints: 
1. 
pre-operation study visit and  
2. 
post-operation study visit of 
first eye at 3-6 months after 
the surgery 
3. 
post-operation study visit of 
second eye at 3-6 months after 
the surgery 
 
4. TRIAL DESIGN 
The study is a randomized controlled trial comparing the change of dynamic stability, gaze 
characteristics, visual function, and quality of life measurements between Toric and non-Toric 
intraocular lens (IOL) groups.  

 
 
 
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The study is a double masked, parallel group design.  140 cataract patients with astigmatism >1.0D at 
the Royal Eye Infirmary (REI) of Derriford Hospital will be recruited and randomly assigned to either 
receive Toric IOLS or non-Toric IOLs for bilateral lens replacement surgery.  The randomization will be 
conducted by the CI who is not involved in the surgical intervention nor the outcome measure 
assessments. The participants will not know which types of IOLs they are receiving and the study 
coordinator who assesses the outcome measures will be masked to the types of IOLs given to the 
participants. Study visits will be carried out before surgery, 3-6 months after first and second eye 
surgery.  
 
5. TRIAL SETTING 
This is a multi-centre trial.  The screening and recruitment of participants will take place at the cataract 
clinic at the REI of Derriford Hospital, University Hospitals Plymouth NHS Trust.  The intervention of 
Toric IOLs or non-Toric Monofocal IOLs cataract correction surgery will be carried out by the PI and his 
ophthalmologist team at the REI.  The three study visits for outcome measurements will be carried out 
by masked assessors who are Allied Health Professionals (Optometrists or Physiotherapists) at the UoP 
(PAHC building). 
 
6. PARTICIPANT ELIGIBILITY CRITERIA 
140 cataract patients over the age of 50-year-old with astigmatism >1.0D undergoing bilateral 
intraocular lens replacement surgery will be recruited from the REI of the UHP over a three-year period.  
Three study visits will be arranged for each participant at the UoP (PAHC building) and will be followed 
up from before the cataract surgery to up to 12 months after the second eye cataract surgery.  
 
6.1 
Inclusion criteria 
• Participants capable of giving informed consent 
• Age 50 years or above 
• Diagnosed with bilateral cataract with corneal astigmatism 1.00D or above 
• Previously consented to routine NHS cataract surgery 
 
6.2 
Exclusion criteria 
• Irregular astigmatism, Amblyopia  

 
 
 
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• Any pre-surgical corneal complications or pathology such as Fuchs dystrophy, keratoconus  
• Macular pathology, glaucoma, retinal disease, abnormal iris or pupil deformation 
• Irregular or malformed eyelids such as ptosis, chalazion or severe blepharitis  
• Previous corneal or intraocular surgery  
• Any patient who does not have traditional phacoemulsification extraction will be excluded from 
the reminder of the study  
• Incapable of giving informed consent due to lack of mental capacity, problems with 
communication or language and any conditions preventing the patient from fully understanding 
the procedures and nature of the study 
• Predicted bilateral post-op corneal astigmatism of <1.50D, dilated pupil size smaller than 5mm 
• Unable to walk independently with or without walking aids for 10 meters 
 
7. TRIAL PROCEDURES  
This is a multi-centre, parallel randomized controlled trial study comparing the clinical outcomes of 
Monofocal Toric IOLs versus Monofocal non-Toric IOLs in cataract patients with astigmatism undergoing 
bilateral intraocular lens replacement surgery. 
7.1 
Recruitment 
This study aims to recruit 140 participants over three years.  The participants will be randomly assigned 
into Toric Monofocal IOLs group or non-Toric Monofocal IOLs group.  The recruitment will take place at 
the cataract clinic at the REI of UHP.  Adult cataract patients referred for cataract replacement surgery 
at REI, from community Optometrists and GPs, will enter a streamlined pathway whereby patients 
attend a single pre-surgical visit.  During this clinic visit, the ophthalmologist surgeons will carry out 
medical screening and acquire relevant clinical measures, along with consent for the surgery.   
The clinical team of REI will identify potential participants when they review the cataract surgery 
referral and medical records to arrange pre-surgery clinic appointment.  A short version of PIS of this 
study will be sent out with the appointment letter to potential patients to give them time to read about 
the study before the recruitment at the clinic appointment.  
The initial approach to recruit the potential participants will happen at the pre-surgery appointment at 
REI by the REI clinical team. One of the clinical team members will identify potential participants based 

 
 
 
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on surgery referral forms or medical records, and approach the potential participants to ask if they 
would like to discuss about a research project or have read the short version PIS that was sent with the 
appointment letter. The patients will then be introduced to a member of the research team, present at 
the REI, to provide further explanation of the study and if willing, the potential participant will be 
consented.  Consent will occur on the day at the clinic. The rationale for this is that potential participants 
only attend a single pre-surgical visit and so there are no other opportunities to bring a participant back 
to the hospital for consent prior to the surgery.  Should a participant wish for a longer period to think 
about participating in the study, then consent will be taken at the first study visit.  However, most 
participants will be consented at their routine pre-surgical clinical visit.  
7.1.1 Participant identification 
Cataract surgery is a streamlined service where all cataract patients referred for cataract replacement 
surgery are given a single pre-surgical clinical appointment at the REI of UHP.  During this pre-surgical 
visit appointment, the clinical team will identify potential participants for the study based on the 
referral form.  Adult cataract patients aged 50 years or above with astigmatism and have previously 
consented for routine bilateral cataract correction surgery at the NHS will be identified as potential 
participants for the study.  The initial approach to the potential participants will be conducted by a 
member of the routine clinical care team, who will ask if the potential participants would like to be 
introduced to a member of the research team to discuss about a research study.  If agreeable, then the 
potential participant will be introduced to the member of the research team present at REI.  That team 
member will discuss the study with the potential participant, give them a copy of the PIS and will answer 
any questions about the study.  If willing, the potential participant will then be consented.  However, if 
the potential participant would like more time to consider their participation in the study, then their 
details will be collected, and they will be contacted at a later date.  If they are willing to take part, 
consent will be secured at the first pre-surgical study visit at the UoP.  
7.1.2 Screening 
For potential participants who expressed interest in taking part in the study, they will be screened 
against inclusion and exclusion criteria by the Ophthalmologists (PI and his ophthalmology team) during 
the screening appointment based on routine pre-surgery examination result and medical record. No 
extra equipment or examination procedures will be needed.  

 
 
 
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7.1.3 Payment  
Any routine appointments for the cataract surgery procedure will not incurred reimbursement.  
The three additional assessment visits at the UoP, one before eye surgery (baseline), one 3-6 months after 
first eye surgery and one 3-6 months after second eye surgery will be reimbursed for a reasonable nominal 
fee (£20) to cover any travel expenses and the additional car parking fee. 
 
7.2 Consent  
Prior to participant recruitment and any procedures for this study, ethical approval will have been 
obtained from both the Health Research Authority and the NHS Research Ethics Committee.  
Potential participants will be asked to sign the written informed consent form on the same day as their 
pre-surgical routine visit at the REI (where they are consented for surgery) by a member of the research 
team.  This is to accommodate the cataract surgery clinical pathway and to reduce the need for the 
patients to travel back to REI for signing the written informed consent form. Following the current 
cataract surgery clinical pathway, patients attend the REI for a pre-assessment cataract clinic 
appointment to discuss cataract surgery with their ophthalmology surgeons. If the patients would like 
to go ahead, consent for surgery is obtained during this appointment. The patients are then placed on 
a waiting list and the next time they are seen is on the day of surgery. With discussion with the sponsor, 
it is felt that obtaining consent at REI, where the patients will be having their surgery, is most 
appropriate in terms of safety and it also allow potential participants to discuss elements of cataract 
surgery directly with the clinic team or the surgeons. If the consent is obtained at the study site, the 
academic researchers, who are not ophthalmologists, would not be able to discuss the surgical aspect 
related to this study. There is a long period between this pre-assessment appointment and the surgery 
(several weeks or months). So, the patients will have considerable time to further consider about their 
participation. At each study visit, time will be provided for participants to ask questions or reconsider 
their participation. 
All potential participants will be informed that participation in this research study will be entirely 
voluntary.  No one will be coerced against their will and no undue influence will be exerted upon the 
patient.  The participants have the right to refuse participation without giving reasons and their decision 
will be respected.  The participants are also free to withdraw at any time from the trial without giving 

 
 
 
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reasons and without prejudicing his/her further treatment.  Data collected up to the point of 
withdrawal from the study will be used in the analysis.  
 
7.3 
The randomisation schemes 
The PI will be responsible for recruitment of potential participants from the Cataract clinic at UHP and 
oversee the consent and eligibility process carried out by the study coordinator.  All potential participants 
will be allocated a unique identification number.  The CI, who is independent of the outcome assessments 
and interventions, will randomize the participants between the intervention and control groups.  He will 
allocate a pseudonymous participant number from 1 to 140. Using simple randomisation with 1:1 
allocation ratio through random.org, the 1 to 140 number will be randomly assigned into two groups (Toric 
IOLs versus non-Toric IOLs). The randomization list will then be passed to the PI, who when recruiting the 
participants at the pre-surgery clinic can know which type of IOLs (Toric or non-Toric) to prepare for the 
cataract surgery.  At study commencement, each number will be allocated to one of the two groups 
randomly.  This means that subjects are allocated to either arm of the study at the point of recruitment. 
The randomized list will be held by the PI, who delivers the intervention surgeries.  The PI needs to know 
which lenses are allocated to the patients for surgery purposes but will not participate in the outcome 
assessment.  The study coordinator who is the assessor of the outcome measures will be masked to the 
allocation of lenses.  
 
7.3.1 Method of implementing the randomisation/allocation sequence 
The study randomization scheme will use simple randomization with a 1:1 allocation ratio using 
Microsoft Excel with same number of participants in each of Toric IOLs group and non-Toric IOLs group.  
The consenting patients will be randomly assigned to one of two groups: Toric IOLs with open loop 
haptic design and standard non-Toric IOLs of similar haptic design. 
7.4 
Blinding 
The participants will be masked to the interventions prior to the surgery.  They will be told which IOLs they 
received at the end of their final visit.  The CI will conduct the simple randomization for the participants 
through the random.org and he will be masked to the outcome assessment.  The randomized list of 
participants will be passed to the PI and his ophthalmologist team to prepare the IOLs and deliver the 

 
 
 
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cataract correction surgery.  So, the PI cannot be masked to the intervention, but he is masked to the 
outcome assessment.   
The outcome assessors for study visits will be masked to the interventions given to the participants.  In the 
post-surgery study visit, the outcome assessors will carry out the dynamic stability reassessment before 
any visual assessment to ensure they are still masked to the primary outcome measures as the visual 
assessment will reveal which types of the IOLs the participants received. 
7.5 
Emergency Unmasking 
During the follow up study visit, if the outcome assessors discover any medical conditions or 
complications that require further attention, the participants will be referred back to the cataract clinic 
(for eye complications) or to their GP for any other medical concerns such as acute osteoarthritis 
needing review of medication.  As the study visit takes place at three to six months after the surgery, 
post-operative complication regarding the IOL implantation or cataract surgery procedure is unlikely.  
In case it happens, the outcome assessors will be unmasked to the type of interventions received by 
the patients for further care by asking the patients directly, reviewing discharge summary or contacting 
CI who holds the randomization list.   
7.6 
Baseline data 
At each study visit based at the UoP, the participant’s full name, DOB, address and contact details will be 
checked for identification purposes.  These details will remain separate from the study data which will be 
identified using the unique study number allocated to the participants.  
The outcome measures will include the following: 
- General demographic information such as age, gender, ethnicity, relevant medical history, cataract 
diagnosis and vision assessment results. This will last about 10 minutes. 
- Dynamic stability assessment lasts about 30 minutes.  Three motion sensors will be put on the 
participants’ body (neck, lower back and upper leg) and they will be asked to wear a special eye tracking 
glass (figure 1).  After that, the participants will be asked to perform a Timed Up and Go (TUG) test which 
involves getting up from a chair, walking 3m-distance and return to sit back on the chair.  They will also be 
asked to walk over obstacles on level ground and the last mobility task is walking up and down a 
standardized staircase.  Movement outcomes will be measured using three-dimensional motion analysis 

 
 
 
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(ProMove 3D, Inertia Technology, The Netherlands) and eye tracking data will be collected via Tobii-pro 
glasses 2 (Tobii AB, Sweden) (figure 2 and 3).  Three trials will be taken to estimate the average and the 
best recorded time will be taken for the TUG test.  As all the participants are active community dwelling 
elderly without mobility problem, the dynamic stability tasks are no more demanding than their usual daily 
activities.  The PPI also include discussion about the demand of the assessment and all participants agreed 
the dynamic stability tests only required low level mobility and no concerns were raised. 
- Some qualitative data will be collected via self-administered questionnaires which takes about 15 
minutes.  Risk of fall will be assessed with the short Fall Efficacy Scale (FES-short) and Fear of Falling 
questionnaire. Vision specific quality of life will be assessed with CAT-PROM 5 questionnaire. 
- Standard visual function assessment will also be carried out to assess visual acuity and degree of 
astigmatism and this takes about 20 minutes. 
A paper CRF has been prepared for this study to collect data directly relevant to the objectives and 
outcomes measures detailed in the protocol. 
(a)  
   
(b) 
Figure 1. Set up with movement sensor and eye tracking device (a) and movement sensors placement 
reinforced with tape (b) 
 

 
 
 
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Figure 2. Example of eyetracking analysis using Tobii pro lab software: a) study of gaze on defined area of 
interest (stool in this example) and b) heat map analysis 
 
Figure 3. Example of movement sensor output data using Promove 3D software 
 
 
 
 

 
 
 
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7.7 
Trial assessments 
Three study visits will be arranged for each participant who have given written informed consent to 
take part in the study.  
Study visit 1: Pre-surgery baseline assessment will take place at the PAHC building of UoP, at least one 
week before the cataract surgery. After the participants have the cataract screening appointment at 
REI, they usually wait 3 to 6 weeks before the cataract surgery.  The first study visit for the pre-operation 
baseline assessment will be arranged during this period. This also gives participants extra time to 
reconsider taking part in the study from when they signed the informed consent form at the REI.  The 
study coordinator will reconfirm informed consent over the phone or by email (whichever is the 
preferred contact method) with the participant before arranging the first study visit and at the start of 
each study visit. If a participant needs to delay or cancel the cataract surgery due to a medical reason, 
the study coordinator will liaise with the PI who is the Ophthalmologist to confirm the participant is still 
suitable to take part in the study.  
Intervention: participants will be randomized into two groups. One group will receive Toric Monofocal 
IOLs and the other group will receive standard non-Toric Monofocal IOLs. 
Study visit 2: Reassessment of outcome measures will take place three to six months after first eye 
surgery at the PAHC building of UoP. 
Study visit 3: Reassessment of outcome measures will take place three to six months after second eye 
surgery at the PAHC building of UoP. 
7.8 
Long term follow-up assessments/ lost to follow-up 
There is no long term follow up assessments. If the participants miss their scheduled study visit, they 
will be contacted by telephone or email (depending on their indicated preference). If no response, two 
more attempts within 2 months will be made.  Participants who are not contactable will be marked as 
lost to follow-up and notification sent to their GP and the PI for their medical records. A notification 
letter will be sent to the participants’ address or email account. 
 
 

 
 
 
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7.9 
Withdrawal criteria 
The participants can withdraw from the study at any time without giving any reason.  Should there be 
a requirement to reassess eligibility, the PI or study coordinator may withdraw the participant if they 
do not meet the inclusion/exclusion criteria. 
7.10 
End of trial 
The third study visit (3 to 6 months after the second eye cataract surgery) is the last contact with the 
participant.  Upon completion of the last study visit for all 140 recruited participants (unless they have 
withdrawn) will be the end of the trial. 
8. TRIAL TREATMENTS 
8.1 
Name and description of investigational medicinal product(s) 
Arms 
Product name 
Further information 
Intervention arm 
Monofocal Toric IOLs: Zeiss AT TORBI 
This is a CE marked medical device which has market 
approval and is being used according to its intended 
use 
Control arm 
Standard Monofocal non-Toric IOLs: 
Zeiss CT ASPHINA 
This is a CE marked medical device which has market 
approval and is being used according to its intended 
use 
8.2 
Regulatory status of the device 
Control arm: Zeiss monofocal intraocular lens.  This has a marketing authorisation (MA) in the UK and 
is being used in its marketed presentation and packaging bearing the MA number. 
Intervention arm: Zeiss Toric intraocular lens.  This has a marketing authorisation (MA) in the UK and is 
being used in its marketed presentation and packaging bearing the MA number. 
Both IOLs are regulated by the Medicines and Healthcare products Regulatory Agency UK (MHRA) and 
compliant with both the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) and the 
General Product Safety Regulations 2005 (SI 2005 No 1803).  Although Toric IOLs are not used in UHP 
but the PI has used both IOLs for cataract surgeries in other hospital in UK. 
 
 

 
 
 
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8.3 
Product Characteristics  
Products 
Characteristics 
Monofocal Toric IOLs: Zeiss AT 
TORBI 
Monofocal Toric IOLs with bitoric and aberration-neutral design offering precise 
correction of astigmatism and achieving spectacle-free distance vision. It is made 
of hydrophilic acrylic material with hydrophobic surface properties. It is a one-
piece plate-haptic construction with four-point fixation for exceptional rotational 
stability. It is implanted into the capsular bag of the eye through a small incision. 
Standard 
Monofocal 
non-Toric 
IOLs: Zeiss CT ASPHINA 
Standard monofocal IOLs used in most of the cataract correction surgery. Similar 
to the Toric, it is made of hydrophilic acrylic material with hydrophobic surface 
properties. It is also a one-piece plate-haptic construction with four-point fixation 
and is implanted into the capsular bag of the eye through a small incision.  
*Link 
to 
technical 
specifications 
of 
all 
model 
of 
Zeiss 
IOLs 
https://www.zeiss.com/content/dam/med/ref_international/products/iols-injectors-bss-ovd/ovd/pdf/iol-ovd-
portfolio.pdf 
 
8.4 
Device storage and supply 
The funder Carl Zeiss will supply both Monofocal non-Toric IOLs and Toric IOLs required for this study 
free of charge to the REI of the UHP.  The PI will have a specific order portal from Carl Zeiss to order 
IOLS according to pre-surgery assessment data.  The IOLs will then be sent to REI directly and handled 
in similar way as other IOLs used in cataract surgery.  The IOLS will be stored as recommended on the 
packaging and requires nothing different than any other brand of IOLs used at the REI. 
All individual IOLs are supplied sterile, non-pyrogenic in its own sterilization pouch.  Sterility is assured 
provided the sterilization pouch seal has not been compromised or the pouch has not been punctured. 
8.5  
Preparation and labelling of device 
The PI and his ophthalmologist team are responsible for calculating the IOL power and select the 
specific IOL as indicated on the individual IOL packaging.  The preparation of the IOLs used in this study 
will be the same as other IOLs used in routine cataract lens replacement surgery. 
The surgeons (PI and his team) need to check the label on the lens box for proper lens model, dioptric 
power and expiration date.  After verification of the dioptric power of the lens after opening, the lens 
will be removed from the pouch and transfer in a case to a sterile environment.  Prior to the actual 
folding process, the lens should be handled by the haptic portion only.  The lens needs to be rinsed 
thoroughly using sterile intraocular irrigating solution.  Then, the lens can be oriented for insertion. 
 
 

 
 
 
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8.6 
Cataract schedules 
Each eye will be implanted with one IOL in the capsular bag and two separate occasions. PI reported at 
the time of writing this protocol, the second eye cataract surgery would be scheduled at around four 
months after the first eye surgery. 
Orientation of the IOLs will be checked before and after implantation of IOLs by the ophthalmologists 
as part of routine care.  The PI has extensive experience using Toric IOLs for cataract surgery, they 
communicated that the cataract surgery using Toric IOLs usually took five to eight more minutes 
because it took longer time to put in and to ensure the axis of the lenses were in a precise position for 
correction of astigmatism. 
 
 
 

 
 
 
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9. SAFTEY REPORTING  
9.1 
Definitions 
Term 
Definition 
Adverse Event (AE) 
Any unfavourable sign, symptom, or disease in a participant, regardless of severity and 
regardless of cause. 
Adverse 
Device 
Effect 
(ADE) 
All untoward and unintended responses to a medical device. The phrase "responses to a 
medical device" means that a causal relationship between the device under investigation 
and an AE is at least a reasonable possibility, i.e., the relationship cannot be ruled out.  All 
cases judged by either the reporting medically qualified professional or the sponsor as 
having a reasonable suspected causal relationship to the device qualifies as a device effect.  
This also includes any event resulting from insufficiencies or inadequacies in the 
instruction for use or deployment of the device and includes any event that is a result of a 
user error. 
Serious Adverse Event 
(SAE)  
A Serious Adverse Event (SAE): 
• 
results in death 
• 
is life-threatening* 
• 
requires inpatient hospitalisation or prolongation of existing hospitalisation** 
• 
results in persistent or significant disability/incapacity 
• 
is a significant or important medical event 
*The term "life-threatening" in this context refers to an event in which the participant was 
at risk of death at the time of the event; it does not refer to an event which hypothetically 
might have caused death if it were more severe. 
**Hospital admissions for elective procedures will not be reported as SAEs. All unplanned 
hospital admissions will be reported as SAEs, regardless of duration of hospital stay. This 
includes visits to ED departments.   
NOTE Device deficiencies that might have led to a serious adverse event where a suitable 
action had not been taken or an intervention had not been made or if circumstances had 
been less fortunate are handled under the serious adverse event reporting system.  
Suspected 
Serious 
Adverse 
Device 
Effect 
(SADE) / Serious Adverse 
Reaction (SAR) 
An Suspected Serious Adverse Device Effect (SADE)/ Serious Adverse Reaction (SAR) which 
has previously been identified in the study protocol that results in:  
• 
Death  
• 
Life threatening illness or injury 
• 
Hospitalisation or prolongation of existing hospitalisation. 

 
 
 
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• 
Persistent or significant disability or incapacity.  
• 
Foetal distress, foetal death or congenital anomaly or birth defect. 
• 
Is otherwise considered medically significant by the Investigator 
All cases judged by either the reporting medically qualified professional or the sponsor.  
Any hospitalisation planned prior to enrolment is not a SADE.  
Unanticipated 
Serious 
Adverse 
Device 
Effect 
(USADE)  
Any serious adverse device effect on health or safety or any life-threatening problem or 
death caused by, or associated with a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the study protocol or 
application (including a supplementary plan or application), or any other unanticipated 
serious problem associated with a device that related to the rights, safety or welfare of 
the subject. 
9.2 Responsibilities  
A sponsor or investigator may take appropriate urgent safety measures in order to protect research 
participants against any immediate hazard to their health or safety, without prior authorisation from a 
regulatory body. 
The CI takes primary responsibility for the conduct of this study. They will also lead and manage all 
investigators of this study and coordinate with the sponsor. They are responsible for the adherence and 
implementation of safety reporting relating to the study visits at the UoP (PAHC building). 
The PI is responsible for management of the participant recruitment and clinical interventions at the 
UHP site.  The PI is also responsible for the adherence and implementation of safety reporting relating 
to the cataract surgery, clinical care or at the site of REI of Derriford Hospital and for coordination with 
CI. 
9.3 Reporting of AEs and ADEs  
Only the following AE’s occurring during the study, observed by the investigator or reported by the 
participant will be recorded on the CRF.   
− AE’s related to the treatment, but not including well known side effects due to eye drops such 
as blurriness. 
− AE’s associated with falls. 

 
 
 
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The following information will be recorded: description, date of onset and end date, severity, 
assessment of relatedness to device, other suspect drug or device and action taken.  Follow-up 
information should be provided as necessary.   
The relationship of AEs to the device will be assessed by a medically qualified investigator and will be 
followed up until resolution, or the event is considered stable.  Any events continuing at the end of the 
study will be followed up by the participants GP and/ or the routine clinical care team until discharge. 
This will apply to participants who withdraw from the study. 
9.4 Recording and reporting of SAEs, SADEs and USADEs  
This study uses CE marked devices and is not regulated by the Medicines and Healthcare products 
Regulatory Agency (MHRA).  All SAE/SADE/UADEs need to be reported to the sponsor R&D within one 
working day of the investigator team becoming aware of them.  The Chief Investigator will assess the 
event for expectedness using the current study protocol, see section 9.5 Known (expected) 
complications associated with Toric IOL surgery. 
Reports of related and unexpected SAEs/ SADE’s should be submitted by the Sponsor to ethics within 
15 days of the Chief Investigator or Principal becoming aware of the event, using the SAE report form 
for non-CTIMPs published on the HRA website.  
All reporting to R&D should be by e-mail the Research Governance Manager (RGM) or their Deputy 
giving as much information about the incident as possible. 
The RGM will undertake an initial review of the information.  Events will be followed up until resolution, 
any appropriate further information will be sent by the research team in a timely manner.  Any events 
continuing at the end of the study will be followed up by the participants GP and/ or the routine clinical 
care team until discharge.  This will apply to participants who withdraw from the study. 
Reporting to the Manufacturer will be done in liaison with the Chief Investigator.  
The Manufacturer has a legal obligation to report all events that need to be reported to the Nominated 
Competent Authority immediately (without any unjustifiable delay) if a link is established between the 
event and the device, but no more than: 

 
 
 
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• 2 days following the awareness of the event for Serious Public Health Threat. 
• 10 days following awareness of the event for Death or unanticipated serious deterioration 
in health. 
• 30 days following the awareness of the event for all other event meeting the SAE criteria. 
In the event of an accident, incident or near miss relating to cataract surgery or clinical care or happens 
at the Derriford Hospital, in addition to previous reporting requirements, the recording and reporting 
should follow the Incident Management Policy of the University Hospitals of Plymouth NHS Trust.  The 
PI or need to report via UHP Datix and notify the CI and Sponsor.  
In addition, all accidents, incidents, near misses during study visit at PAHC building of UoP must be 
reported following the Universities internal procedures.  The CI will assess the seriousness of the event 
for reporting to the Health and Safety Department according to the Health and Safety Policy of the 
University and notify the sponsor and PI.  
9.5 Known (expected) complications associated with Toric IOL surgery 
Intraoperative risks 
• Anterior segment bleeding 
• Posterior capsular rupture 
• Zonular dehiscence 
• Incomplete continuous curvilinear capsularhexis 
• Severe iris/corneal Trauma 
• Anterior vitrectomy 
Post-operative complications: 
• endophthalmitis (inflammation of the internal eye tissues, most commonly caused by an 
infection) and bleeding. 
• irregular astigmatism 
• dry eye 
• keratectasia (progressive myopia, irregular astigmatism, ghosting, fluctuating vision and 
problems with scotopic vision.  The progression leads to severe loss of corrected visual acuity) 
• Patient reported subjective complaints of halos, glare, and ghost images. 
• Wound leak 
• Flat anterior chamber 
• Hyphema 
• Vitreous in anterior chamber 
• Vitreous in wound 

 
 
 
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• Raised IOP  
• Pupillary block 
• Anterior synechiae 
• Posterior synechiae 
• Deposits on IOL 
• Fibrin in Pupil 
• Nuclear remnants 
• Cortical Remnants 
• Retinal detachment 
• Cystoid macular oedema 
• Anterior capsular Opacification 
• Posterior capsular opacification 
• Intraocular lens tilt and decentration 
• Cells/flare in the anterior chamber 
Toric IOLs have a few other potential complications.  Astigmatism may be overcorrected or under-
corrected. 
As mentioned previously, the Toric IOL may rotate off-axis.  There will be some partial effect if it rotates 
off-axis.  For example, the correction effect of the Toric IOLs is reduced by 10% for every 3o rotation off-
axis.  For the lens to lose its full effect, it would have to be off axis by 30o.  Prevention of IOL rotation 
includes complete removal of Ophthalmic Viscosurgical Devices (OVDs), especially posterior to the IOL. 
Most patients do extremely well following this surgical technique.  The technical surgical learning curve 
for the surgeon is minimal for an outcome that is reliably predictable.  Toric IOLs, exclusively or in 
conjunction with astigmatic keratotomy and/or strategic cataract incision placement, can result in 
excellent management of astigmatism. 
9.6 Notification of deaths  
Any study death in relation to the cataract surgery should be reported by the corresponding surgeon 
and CI, following the Care of Deceased Patient Policy of the UHP.  The study sponsor must also be 
notified as per the reporting of SAEs, SADEs and USADEs in 9.3.  
9.7 The type and duration of the follow-up of participants after adverse reactions.  
All adverse events must be followed-up until resolution or death of the participant.  Any events 
continuing at the end of the study will be followed up by the participants’ GP and/ or the routine clinical 
care team until discharge. 
9.8 Reporting urgent safety measures   

 
 
 
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The investigator and sponsor have the authority to deviate from the protocol if doing so relates to the 
immediate safety of a participant, where continuing to follow protocol would put that participant at 
risk.  This is classed as an urgent safety measure and must be reported to REC immediately and in any 
event within three days, in the form of a substantial amendment, that such measures have been taken 
and the reasons why.  
 
10. STATISTICS AND DATA ANALYSIS 
10.1 
Sample size calculation 
Sample size test calculation was carried out with the G*Power 3.1 program (Faul et al., 2007) for 
comparison of the main outcome measure of dynamic balance (between IOL design) using mixed 
ANOVA (repeated measures, between factor being the type of IOL).  
Based on of the dynamic balance measurement (JERK score) in a previous study (Mancini et al., 2011) 
an estimated medium effect size (0.25) will be used.  With a power of 85% and level of significance (p) 
set at 0.05 and effect size of 0.25, 55 participants will be required in each group (Monofocal vs Toric 
IOL).  Accounting for a 20% drop out rate, 70 participants will therefore be recruited in each group (A 
total of 140 participants). 
10.2 
Planned recruitment rate 
140 participants will be recruited over three-year period (minimal sample size of 110 plus 20% drop out 
rate estimation) 
According to latest data from the National Ophthalmology audit database by the Royal College of 
Ophthalmologists, the REI of UHP performed 2525 cataract between 1st of September 2018 to 31st 
August 2019.  The PI who performed cataract surgery at the REI reported around 3000 cataracts surgery 
were performed last year and the number is estimated to be similar this year.  Due to COVID, there 
were longer waiting list and the waiting time between first and second cataract surgery at UHP has 
increased to about 4 months. 
Approximately 40% patients undergo cataract surgery on both eyes (Jaycock, 2009 #281) (Day, 2015 
#282).  Among patients eligible for cataract surgery in NHS, 42% were reported to have mild to 
moderate astigmatism (>1.0 D) (Day, 2019 #283).  Therefore, it is estimated about 500 patients at REI 
annually will meet the inclusion criteria (needing cataract surgery in both eye with mild-moderate 
astigmatism) and our target for 140 participants out of the potential 1500 patients over three year 

 
 
 
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should be a feasible number (10% of potential eligible patients), especially with the increasing number 
of cataract surgeries done every year. 
10.3 
Statistical analysis plan 
All data will be assessed for normality using a combination of assessing histogram plots and the Shapiro-
Wilks Normality Test.  Descriptive summary statistics for outcome measures relating to vision (acuity 
and refraction) will be recorded as mean +/- standard deviation. 
Mixed ANOVA and post-hoc Bonferroni tests will be used to determine the statistical differences in the 
baseline characteristics and outcome measures between the Toric monofocal IOLs group and the non-
Toric monofocal IOLs group.  The between-subjects factor would be type of IOL lens and the within-
subjects factor would be time (pre-surgery vs post-surgery).  Level of significance will be set at 0.05. 
 
 

 
 
 
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10.3.1 Summary of baseline data and flow of patients 
Randomization 
Sample size calculation 
with the G* Power 3 
program 
N=140 
Randomization list generated in 
 MS Excel at the 
commencement of the study by 
the Chief investigator: 
independent of assessment and 
intervention 
Execution- randomization list will be 
held by the PI (ophthalmologist at REI) 
so that they know who is allocated into 
either the intervention or control groups 
according to the list. 
Outcome measures 
Trial description 
Outcome recorded 
Primary 
outcomes 
Dynamic stability 
1.Eye gazing 
characteristics 
Gazing duration on obstacles 
during the obstacle 
negotiation.  
Area of interest and 
corresponding glazing duration 
during stair walking 
1. Gazing duration and frequency 
on obstacles and area of 
interest. 
 
2. Heat map on area of interest 
from eye tacking device 
 
all data will be recorded and saved in file 
name in the format: participant number-
obstacle-trial1/2/3-date. 
2.Movement 
biomechanics 
-participants perform Timed up 
and go (TU&G) test involving 
getting up from chair ,then 
walking over 3m level ground, 
turning and walking back to sit 
down on the chair 
 
- participants walk over a 3m 
level ground with obstacles of 
different contrast colour to 
background.  
 
- accelerometers of head tilting 
and change in movement of 
centre of gravity will be 
recorded during TU&G test and 
during crossing over obstacles. 
1. accelerometers data of change 
in head tilting and centre of 
gravity will be recorded  
2. Duration in seconds of TU&G 
test 
 
all data will be recorded and saved in file 
name in the format: participant number-
obstacle-trial1/2/3-date. 
Secondary 
outcomes 
1.Refraction and visual 
acuity 
-standardized protocol for 
routine visual function test 
-vision 20/20, sphere cylinder, axis 
-DVA, NVA 
-IOL rotation (for Toric IOL group only) 
2.Questionnaire 
Short Fall Efficacy Scale International 
Fear of Falling Questionnaire 
CAT-PROM 5 Quality of life Questionnaire 
• A CRF form has been prepared for this study 

 
 
 
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10.3.2 Primary outcome analysis- Dynamic stability in three functional activities 
The following outcomes will be collected at three time points: before surgery, 3 to 6 months after first 
and second eye surgery. 
Outcome measures 
Data collected 
Data type/ details 
Quantitative Statistical Analysis 
Dynamic stability 
during turning, 
obstacle crossing 
and stair walking 
Accelerometers data (angular 
position and acceleration) of 
change in head tilting and 
centre of mass will be recorded  
 
Performance of TU&G test 
Interval 
 
Centre of mass and head movement 
will be calculated using ProMove 3D 
(Inertia Technology, The Netherlands) 
and MATLAB.  
 
The angular position, velocity and 
acceleration of the sensors will be 
tracked on each participant 
 
Duration in seconds of TU&G test 
The average reading of the 3 
trials in each functional activity 
will be calculated. 
 
Mixed ANOVA and post-hoc 
Bonferroni tests will be used to 
determine the differences 
between the Toric IOLs group 
and Monofocal IOLs group 
before surgery and 6 months 
after second eye surgery. 
10.3.3 Secondary outcome analysis 
Outcomes 
Data collected 
Data type 
Quantitative statistical Analysis 
Eye glazing 
characteristics 
during obstacle 
crossing and stair 
walking 
Gazing duration on 
obstacles and area of 
interest on environment 
during stair walking 
 
Area of interest 
determined by heat map 
(area with highest 
frequency of gazing) 
Interval 
 
Gaze pattern of 
location of hotspots 
and duration of gaze 
will be collected using 
Tobii pro eye tracker. 
 
% time spent on 
fixation of highlighted 
object or area of 
interest 
 
Best performance 
among 3 trials will be 
used. 
Mixed ANOVA and post-hoc Bonferroni tests will be used 
to determine the differences between the Toric IOLs group 
and Monofocal IOLs group before surgery and 6 months 
after second eye surgery. 
Refraction and 
visual acuity 
 
-Visual acuity (vision, 
sphere, Cylinder, Axis, 
DVA, Add NVA) 
-IOL tilt and decentration 
-IOL rotation (for Toric 
IOL group only) 
Interval 
 
Average tilt, 
decentration and 
rotation of lens will be 
analysed by calculating 
average value in Toric 
and monofocal groups. 
Bland Altman will be 
used to study the 
agreement of position-
level of error for IOLs 
tilt, decentration and 
rotation. 
Mixed ANOVA and post-hoc Bonferroni tests will be used 
to determine the differences between the Toric IOLs group 
and Monofocal IOLs group before surgery and 6 months 
after second eye surgery. 
 
Unaided and aided distance visual acuity will be recorded 
in Log MAR and comparisons between the two lenses pre 
and post cataract surgery will be conducted using a two- 
way ANOVA.  
Post-operative refractive astigmatism will be analysed 
using the Alpins method*. 
Correlation between SIA and TIA will be assessed, and 
dependent t-tests will be used to analyse the remaining 
metrics in the two groups 
Questionnaire 
Short Fall Efficacy Scale 
International 
Ordinal 
(non-parametric) 
Mixed ANOVA and post-hoc Bonferroni tests will be used 
to determine the differences between the Toric IOLs group 

 
 
 
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Fear of Falling 
Questionnaire 
CAT-PROM 5 Quality of 
life Questionnaire 
and Monofocal IOLs group before surgery and 6 months 
after second eye surgery. 
 
*Post-operative refractive astigmatism will be analysed using the Alpins method. Cylindrical power and 
axis will be converted to vectors (J0 and J45; Equations 1 &2).  
Equation 1: Calculation of J0 
𝐽0=𝐽cos2𝛼  
J0 = cylindrical effect at 180°  
J = cylindrical power  
a = axis in radians 
Equation 2: Calculation of J45 
𝐽45=𝐽sin2𝛼  
J45 = cylindrical effect at 45°  
J = cylindrical power  
a = axis in radians 
 
Target induced astigmatism (TIA) is the astigmatic correction predicted to occur and will be calculated 
with Equation 3. 
Surgically induced astigmatism (SIA) is the astigmatic correction achieved post-operatively and 
calculated as Equation 4.  
 
Equation 3: Target induced 
astigmatism 
𝑇𝐼𝐴= √((𝑃𝑟𝑒𝑂𝑝 𝐽0 −𝑃𝑟𝑒𝑑𝑖𝑐𝑡𝑒𝑑 𝑟𝑒𝑠𝑖𝑑𝑢𝑎𝑙 𝐽0 )2 +( 𝑃𝑟𝑒𝑂𝑝 𝐽45−𝑃𝑟𝑒𝑑𝑖𝑐𝑡𝑒𝑑 𝑟𝑒𝑠𝑖𝑑𝑢𝑎𝑙 𝐽45)2) 
Equation 
4: 
Surgically 
induced astigmatism 
S𝐼𝐴= √((𝑃𝑟𝑒𝑂𝑝 𝐽0 −𝑃𝑜𝑠𝑡𝑂𝑝 𝐽0 )2 +( 𝑃𝑟𝑒𝑂𝑝 𝐽45−𝑃𝑜𝑠𝑡𝑂𝑝 𝐽45)2) 
 
The Correction index (CI) is the ratio of SIA to TIA (Equation 5) and difference vector is the difference 
between TIA and SIA (Equation 6).  
Equation 5: Correction Index 
𝐶𝐼= 𝑆𝐼𝐴𝑇𝐼𝐴 
Equation 6: Difference Vector 
𝐷𝑖𝑓𝑓𝑒𝑟𝑒𝑛𝑐𝑒 𝑉𝑒𝑐𝑡𝑜𝑟=𝑇𝐼𝐴−𝑆𝐼𝐴 
 
10.4 
Subgroup analyses 
Within the Toric IOLs group, a subgroup of participants presented with post-surgery IOL rotation > 5 
degree will be isolated to compare the outcomes. This subgroup of participants is very likely to need 

 
 
 
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another adjustment surgery. Their data will inform the impact of IOLs rotation on surgery complications 
and whether such rotation may be related to degree of astigmatism.  
In both the Toric IOLs and non-Toric IOLs group, subgroups of different degree of astigmatism: mild 
(<1.50), moderate (1.5-3.0) and severe (3.0+) will be differentiated to compare the outcomes to help 
inform if Toric IOLs offer similar beneficial effect across cataract patients with wide range of 
astigmatism. This will help to identify which patients should be referred for Toric IOLs and support 
evidence-based practice. 
10.5 
Participant population 
Participants will be adult cataract patients of any sex, aged 50 years or above with astigmatism >1.0D 
who have already consented for bilateral cataract correction surgery at the REI of Derriford Hospital.  
10.6 Procedure(s) to account for missing or spurious data  
If the participants miss the study visit appointment without notification, they will be contacted for two 
more attempts within two months of the planned visit date. A letter of notification will be sent to their 
home address and if they have not replied within four weeks, they will be withdrawn from the study 
and any related data will be discarded. 
 
11. DATA MANAGEMENT  
11.1 
Data collection tools and source document identification 
A case report form (CRF) has been prepared for this study to record the participants’ data collected 
during the three study visits. The CRF data will be used to perform statistical analysis and aid audit of 
data during and after the trial. 
Printed copies of CRF will be used in the three study visits for data collection.  An electronic copy will 
be made and stored in a designated folder of the MS OneDrive provided and maintained by the UoP.  
All study data will be recorded in pseudonymised form using designated participant identification code.  
Access to the drive is password protected and limited to the research team.  All original singed 
pseudonymised CRF will be stored in a designated and lockable cabinet at the Optometry department 
of the UoP and the informed consent forms will be stored separately in another designated lockable 
cabinet to minimize risk of exposing participant identity. 

 
 
 
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Guidance can be found here: 
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2
010/08/WC500095754.pdf 
11.2 
Data handling and record keeping  
All research team members of this study are registered medical or Allied Health Professionals who have 
completed update training on the Data Protection legislation including the General Data Protection 
Regulation (GDPR) and bounded by a code of conduct.  The UHPNT and UoP both have their own policy 
to ensure compliance of data protection and their own IT team to support electronic system for data 
storage. Password protected laptop and MS OneDrive will be provided by the UoP and maintained by 
their IT team.  A lockable filing cabinet in a locked room at the Optometry department of the UoP will 
be provided to store any paper records containing participant data. 
 
11.3 
Access to Data 
Direct access will be limited to the research team members (CI, PI and co-investigators).  Further access 
will be granted to authorised representatives from the UoP, UHP and the regulatory authorities to 
permit study related monitoring, audits, and inspection in line with participant consent. 
11.4 
Archiving 
At the end of the study, electronic data files will be share with UHPNT for archiving using MS OneDrive. 
All original documents and data files will be detained and archived for 10 years in line with Trust policy.  
 
12. MONITORING, AUDIT & INSPECTION 
The study will be subject to monitoring by UHP under their remit as sponsor to ensure adherence to 
the UK Policy Framework for Health and Social Care Research (2017).  First routine monitoring visit will 
occur within approximately 30 days of local R&D Confirmation of Capacity and Capability. The 
subsequent level of monitoring will be determined by a risk assessment, or on a for cause basis. The 
study may also be audited/ inspected by regulatory bodies to ensure compliance with national 
regulations. 

 
 
 
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13. ETHICAL AND REGULATORY CONSIDERATIONS 
13.1  Research Ethics Committee (REC) review& reports 
• Before the start of the trial, sponsorship approval will be sought from and the UHP and HRA 
approval will be obtained through the Integrated Research Application System (IRAS) system. 
• Substantial amendments that require review by REC will not be implemented until the REC 
grants a favourable opinion for the trial. 
• All correspondence with the REC will be retained in the Trial Master File/ Investigator Site File  
• an Annual Progress Report (APR) will be submitted by the CI to the REC within 30 days of the 
anniversary date on which the favourable opinion was given, and annually until the study is 
declared ended 
• the CI will notify the REC of the end of the study 
• if the trial is ended prematurely, the CI will notify the REC, including the reasons for the 
premature termination 
• within one year after the end of the trial, the CI will submit a final report with the results, 
including any publications/abstracts, to the REC 
13.2  
Peer review 
The research protocol has been reviewed by the funder, Carl Zeiss Meditec AG. The study is also part 
of PhD project of Ms Sherrie Choy under the UoP and the research protocol has been reviewed by 
independent reviewer Dr Antonio Del Aguila-Carrasco who is a lecturer in Optometry and have 
expertise in IOLs research methodology and statistics. The research methodology and statistics have 
been reviewed by Prof Victoria Allgar, Director of the Peninsula Clinical Trials Unit (PenCTU) of the UoP. 
13.3  
Public and Patient Involvement 
A Public and Patient Involvement (PPI) has been included at the protocol development stage. A total of 
seven participants were involved in the PPI to comment on the proposed study. A summary report can 
be found in appendix 16.4 
This study follows on directly from previous research and is similar in structure to the clinical trials on 
IOLs conducted by the research team. We have evaluated the use of these lenses at UHP which 
demonstrated excellent visual outcomes following Toric implantation:   

 
 
 
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Swampillai AJ, Khanan Kaabneh A, Habib NE, Hamer C, Buckhurst PJ. (2020) Efficacy of toric intraocular 
lens implantation with high corneal astigmatism within the United Kingdom's National Health Service. 
Eye 34 (6) 1142-1148. 
With regards to similar randomised clinical trials, our experience comes from a very similar RCT with 
the same recruitment strategy and number of follow ups. The study has been published last year as 
shown in the reference below. 
Law EM, Aggarwal RK, Buckhurst H, Kasaby HE, Marsden J, Shum G, Buckhurst PJ. (2020) Visual function 
and subjective perception of vision after bilateral implantation of monofocal and multifocal IOLs: a 
randomized controlled trial. Cataract Refract Surg. 2020 Jul;46(7). 
Cataract surgery is a positive experience. Regardless of the arm that the participant is randomised to, 
they will have good visual outcomes following removal of the cataract. Our previous experience of IOL 
RCTs have been that participants have a positive experience and that we have few dropouts. 
13.4  Regulatory Compliance  
• The study will not commence until a HRA research ethics have been granted 
• All the data will be handled in line with GDPR 
• This research project will follow the standard operating procedure of the sponsor and be 
regulated by their R&D team throughout the study period.  
• This research project will also need to comply with the research governance and ethics 
standard of the UHP. 
 
13.5  Protocol compliance  
• Participants not meeting the eligibility criteria specified in the trial protocol will not be 
recruited to the study. 
• Should any accidents happen at any time during the study visits, they will be adequately 
documented on the accident report forms and reported to the CI and the sponsor UHP, in 
compliance to the Incident Management Policy of the UHP. 
• Deviations from the protocol which are found to frequently recur are not acceptable and will 
require immediate action and could potentially be classified as a Serious Breach. 

 
 
 
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13.6  Notification of Serious Breaches to GCP and/or the protocol  
A “Serious Breach” is a breach which is likely to effect to a significant degree –  
a) 
on the safety or physical or mental integrity of the participants of the trial; or  
b) 
on the scientific value of the trial or  
c) 
on the rights of trial participants  
• the sponsor and research committee of the UoP will be notified immediately of any case where 
the above definition applies during the trial conduct phase  
• the sponsor will notify the licensing authority in writing of any serious breach of  
a) 
the conditions and principles of GCP in connection with that trial; or   
b) 
the protocol relating to that trial, as amended from time to time, within 7 days of 
becoming aware of that breach  
13.7  Data protection and patient confidentiality  
The CI, PI and all co-investigators have completed update training in Good Clinical Practice (GCP) by 
NIHR and must comply with the requirements of the Data Protection Act 2018 with regards to the 
collection, storage, processing, and disclosure of personal data. 
The study data collected for each participant will be pseudonymised, each participant will be assigned 
a unique study number upon being recruited for the study.  The participants identifiable information 
i.e. name, DOB, address and contact details will be separately kept from the study data, on a UoP 
computer, only accessible by the researchers of this research project (a copy will be held by the PI at 
UHP).  The password protected encrypted laptop and MS OneDrive will be provided by the UoP and 
maintained by their IT team.  A lockable filing cabinet in a locked room at the Optometry department 
of the UoP will be provided to store any paper records containing participant data. 
At the end of the study, all data will be transferred to the sponsor, UHP, and stored for 10 years in line 
with Trust policy.  
UHP will be the Data Controller for this study, responsible for the management and oversight of the 
data. The UoP will be the Data Processor.  The CI, Professor Phillip Buckhurst of the UoP will be, 
responsible for ensuring that identifiable and pseudonymised information are handled and managed 

 
 
 
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appropriately. The study coordinator is delegated the task of day-to-day management of data within 
the study.   
All members of the research team have a shared responsibility for ensuring the confidentiality of the 
data and that it is handled appropriately in accordance to Data Protection legislation.  
 
13.8  Financial and other competing interests for the CI, PIs at each site and committee members 
for the overall trial management  
The funder, Carl Zeiss Meditec AG, is a commercial company. They are one of the NHS approved IOLs 
supplier but do not supply the cataract clinic of UHP at the time of writing this protocol. The funder 
supplied IOLS for this research project, a full-time PhD studentship, travel subsidy for patients’ study 
visit and expenses for research presentation in conferences. The CI, PI and other co-investigators have 
no other financial interest for the research activities. 
13.9  Indemnity 
This is an NHS-sponsored research study. If an individual suffers negligent harm as a result of 
participating in the study, NHS indemnity covers NHS staff and those people responsible for conducting 
the trial who have honorary contracts with the relevant NHS Trust. In the case of non-negligent harm, 
the NHS is unable to agree in advance to pay compensation, but an ex-gratia payment may be 
considered in the event of a claim.  
The PI is an ophthalmologist, and all co-investigators are allied health professional, they all have their 
additional professional liability insurance with their professional governing body for clinical negligence 
and public liability insurance. 
If a SAE happens during any of the three study visits (on the University site), it has to be reported 
formally to the study CI, Professor Phillip Buckhurst, to assess the seriousness and causality, if deemed 
to be serious it must be reported to the Study Sponsor within 24 hours and would trigger a Serious 
Incident Requiring Investigation (SIRI) by the University.  Additionally, the Optometry department of 
the UoP is responsible for any insurance claim regarding loss or damage to equipment used in the three 
study visits at their campus. 

 
 
 
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UoP has in force an insurance for Professional Negligence indemnity for research and consultancy service. 
It also has in force an employer’s and public liability insurance to cover activities on campus.  
https://www.plymouth.ac.uk/about-us/university-structure/service-areas/procurement/insurance-
certificates 
 
13.10  Post-study care 
No further follow up will be required from the researcher after the third study visit. The participants 
will be continued their usual care. 
Information about the intervention, benefits, risk and right of the participants will be outlined in the 
PIS with contact details to the chief investigator or study coordinator.  A copy of PIS will be retained by 
the participants. 
13.11  Access to the final study dataset 
Direct access will be limited to research team members (CI, PI and co-investigators). Further access will 
be granted to authorised representatives from the UoP, the R&D offices of UHPNT and the regulatory 
authorities to permit study-related monitoring, audits, and inspections in line with participant consent. 
 
14. DISSEMINIATION POLICY 
14.1  
Dissemination policy 
The UHP owns the data arising from the study. 
The research data will be recorded pseudonymously.  The data collected will then be stored in password 
protected University MS OneDrive for data analysis.  
The data will then be analysed by the CI and co-investigators in its pseudonymous form.  No identifiable 
details will be used in any stage of the analysis. 
This project is part of a PhD thesis of the study coordinator.  The results in anonymous form will be 
placed in the thesis for publication on the University’s library system (PEARL).  
A lay summary of study results will be sent to participants.  
14.2  Authorship eligibility guidelines and any intended use of professional writers. 

 
 
 
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Authorship of the content generated by the result will be credited to the research team members: Prof 
Nabil Habib, Prof Phillip Buckhurst, Ms. Sherrie Choy, Dr Catriona MacLennan, Prof Gary Shum, Dr Hetal 
Buckhurst and Prof Victoria Allgar, who have shown substantial contributions to the conception and 
design of this study, analysis and interpretation of data, revising intellectual content critically, writing 
up for publication and being accountable for all research enquiry and integrity.  
The first author will be Ms. Sherrie Choy.  She is the PhD student of this study.  She acts as trial 
coordinator and data manager, as well as conducting outcome measure assessments in the study 
visits.   
Corresponding authors will be Dr Catriona MacLennan, who take primary responsibility for 
communication with the journal during any manuscript submission, peer review and publication 
process to meet the journal's administrative requirements.  
No professional writers will be used in the publication of the study and UHP will be acknowledged in all 
publications.  

 
 
 
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15. REFERENCES 
ASBELL, PA, DUALAN I, MINDEL J, BROCKS D, AHMAD M, EPSTEIN S. Age-related cataract. Lancet. 2005 Feb 12-
18;365(9459):599-609. doi: 10.1016/S0140-6736(05)17911-2. PMID: 15708105. 
BLACK, A. & WOOD, J. 2005. Vision and falls. Clinical and Experimental Optometry, 88, 212-222. 
BRIAN, G. & TAYLOR, H. 2001. Cataract blindness: challenges for the 21st century. Bulletin of the World Health 
Organization, 79, 249-256. 
FAUL, F., ERDFELDER, E., LANG, A. G. & BUCHNER, A. 2007. G*Power 3: a flexible statistical power analysis 
program for the social, behavioral, and biomedical sciences. Behav Res Methods, 39, 175-91. 
FOSTER, A. 2001. Cataract and “Vision 2020—the right to sight” initiative. British Journal of Ophthalmology, 85, 
635. 
JOHNSON, L., SUPUK, E., BUCKLEY, J. G. & ELLIOTT, D. B. 2013. Effects of induced astigmatism on foot placement 
strategies when stepping onto a raised surface. PLoS One, 8, e63351. 
KESSEL, L., ANDRESEN, J., TENDAL, B., ERNGAARD, D., FLESNER, P. & HJORTDAL, J. 2016. Toric Intraocular Lenses 
in the Correction of Astigmatism During Cataract Surgery: A Systematic Review and Meta-analysis. 
Ophthalmology, 123, 275-286. 
KHAN, M. I. & MUHTASEB, M. 2011. Prevalence of corneal astigmatism in patients having routine cataract surgery 
at a teaching hospital in the United Kingdom. J Cataract Refract Surg, 37, 1751-5. 
LORD, S. R. 2006. Visual risk factors for falls in older people. Age Ageing, 35 Suppl 2, ii42-ii45. 
LORD, S. R., SMITH, S. T. & MENANT, J. C. 2010. Vision and falls in older people: risk factors and intervention 
strategies. Clin Geriatr Med, 26, 569-81. 
MANCINI, M., HORAK, F. B., ZAMPIERI, C., CARLSON-KUHTA, P., NUTT, J. G. & CHIARI, L. 2011. Trunk 
accelerometry reveals postural instability in untreated Parkinson's disease. Parkinsonism Relat Disord, 
17, 557-62. 
MONACO, G. & SCIALDONE, A. 2015. Long-term outcomes of limbal relaxing incisions during cataract surgery: 
aberrometric analysis. Clin Ophthalmol, 9, 1581-7. 
READ, S. A., VINCENT, S. J. & COLLINS, M. J. 2014. The visual and functional impacts of astigmatism and its clinical 
management. Ophthalmic and Physiological Optics, 34, 267-294. 
SIDEROV, J., MEHTA, D. & VIRK, R. 2005. The legal requirement for driving in the United Kingdom is met following 
pupil dilatation. Br J Ophthalmol, 89, 1379-80. 
SWAMPILLAI, A. J., KAABNEH, A. K., HABIB, N. E., HAMER, C. & BUCKHURST, P. J. 2020. Efficacy of toric intraocular 
lens implantation with high corneal astigmatism within the United Kingdom’s National Health Service. 
Eye, 34, 1142-1148. 
WILKINS, M. R., ALLAN, B. & RUBIN, G. 2009. Spectacle use after routine cataract surgery. Br J Ophthalmol, 93, 
1307-12. 
 

 
 
 
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16. APPENDICIES 
16.1  Appendix 1-Risk  
Risks associated with trial interventions 
A ≡ Comparable to the risk of standard medical care 
Justification:  The participants recruited in the study are on the list to receive cataract correction surgery. There is 
no difference in risk of surgery between Toric and standard intraocular lens. The two additional study visits may 
cause additional risk due to movement tasks but the additional fall risk would be the same as in any other daily 
activities as this group of participants are active community dwelling elderly. 
Briefly justify the risk category selected : 
What are the key risks related to 
therapeutic interventions you plan to 
monitor in this trial? 
How will these risks be minimised? 
IMP/Intervention  
Body 
system/Hazard 
Activity 
Frequency 
Comments 
Surgery 
complication 
Eye infection 
Usual pre-surgery screening 
and post-surgery care 
1 pre-surgery clinic 
appointment and at 
least 2 post- surgery 
follow up 
Risk level: A 
Reaction to 
eyedrops during eye 
examination 
Eye 
Eye drops will only be 
administrated by chartered 
optometrists. Allergy 
history will checked again 
before administering.  
Once in each study 
visits. Two visits in 
total 
Risk level: A  
Dynamic stability 
test 
Fall 
Mobility assessment will be 
conducted by experienced 
physiotherapists. 
Equipment and 
environment check will 
take place prior to start of 
each testing. 
Two study visits. 
Risk level: A 
All 
participants 
are 
ambulatory 
community 
dwelling 
individuals so 
the risk will be 
similar to 
normal 
mobility 
activities. 
 
 
 

 
 
 
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16.2  Appendix 2 - Schedule of Procedures 
Procedures 
Visits x3 
Screening 
Baseline 
(study visit 1) 
Treatment Phase 
(routine cataract surgery 
schedule and care) 
Follow Up after 
1st eye surgery 
(study visit 2) 
Follow Up after 
2nd eye surgery 
(study visit 3) 
Informed consent 
x 
x 
 
 
 
 
Demographics 
 
x 
 
 
 
 
Medical history 
x 
x 
 
 
 
 
General eye examination 
 
x 
 
 
x 
x 
Visual function 
-visual acuity 
-astigmatism power 
x 
x 
 
 
x 
x 
Eligibility assessment 
x 
 
 
 
 
 
Randomisation 
x 
x 
 
 
 
 
Dispensing 
of 
Toric 
and 
Monofocal IOLs 
 
x 
x 
x 
 
 
Compliance 
(IOLs post-op care) 
 
 
x 
x 
 
 
Dynamic stability assessment  
1. 
Motion sensor and eye 
tracking during Timed 
up & go test (TUG)  
 
x 
 
 
x 
x 
Dynamic stability assessment  
2. 
Motion sensor and eye 
tracking during walking 
over obstacles 
 
x 
 
 
x 
x 
Dynamic stability assessment 
3. 
Motion sensor and eye 
tracking 
during 
stair 
walking 
 
x 
 
 
x 
x 
Risk of fall Questionnaires 
-Short Fall Efficacy Scale 
-Fear of falling 
 
x 
 
 
x 
x 
Quality of life questionnaire 
-CAT-PROM5 
 
x 
 
 
x 
x 
IOL orientation 
 (Toric IOL only) 
 
x 
 
 
x 
x 

 
 
 
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16.3 Appendix 3- Safety Reporting Flow Chart 
 
 
 

 
 
 
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16.4 Appendix 4-Summary of Patient and Public Involvement 
 
Patient and public involvement on research project “Vision and balance changes after bilateral 
implantation of Toric versus non-Toric intraocular lenses in Cataract patients with astigmatism”. 
 
Project title: Pseudophakic vision and lifestyle changes after bilateral implantation of Toric versus non-
Toric intraocular lenses in Cataract patients with astigmatism 
IRAS ID: 286913 
 
Chief Investigator: Prof. Phillip Buckhurst 
Principal Investigator: Prof Nabil Habib 
Collaborators: Dr Catriona MacLennan, Prof Gary Shum, Dr Hetal Buckhurst, Ms Sherrie Choy 
 
Date: 28th June-2nd July 2021 
 
Background of study project 
Cataract is one of the major causes of visual impairment and blindness in the aging population. In UK, 
cataract alone accounts for over a third of the cases of vision impairment in those over 75 years. The 
Royal College of Ophthalmologists estimated around 50% increase in the expected number of cataract 
operations over the next 20 years. During cataract surgery the natural lens within the eye is removed and is 
replaced with an artificial lens called an intraocular lens (IOLs). Cataract surgery using standard monofocal IOLs 
can correct visual error such as short sightedness or long sightedness.  
However, these IOLs do not correct astigmatism which refers to the imperfection in the curvature of 
the cornea- the clear and dome-shaped covering in front of the eye. An eye with severe astigmatism is 
oval in shape (like a rugby ball) instead of spherical (like a football). This oval shape reduces vision and 
causes some distortion. Degree of astigmatism is measured in dioptre (D). A perfect eye has zero 
dioptre. Most people can have between 0.5-0.75 D and people with 1.5D or more typically need to wear 
contact lenses or eyeglasses for clear vision. Astigmatism can cause impaired vision, which has been 
shown to reduce quality of life and increase fall risk. It has been reported that around one fifth of people 
attending for cataract surgery have astigmatism (Swampillai et al., 2020). A modern type of IOLs called 

 
 
 
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Toric IOLs provides an alternative design with correction of astigmatism. The Toric IOLs offers better 
vision correction and may reduce the need for spectacles for cataract patients with astigmatism. 
Therefore, full correction of refractive error for cataract patients of any degree of astigmatism using 
specialized Toric IOL could be a more cost-effective and patient-centred approach. 
This study aims to determine if Toric intraocular IOLs, when compared to standard IOLs, provide better 
visual function, dynamic stability and quality of life. This information has the potential to influence the 
availability of types of IOLs offered to cataract patients in NHS. 
 
Table 1. PPI for Toric IOLs study using GRIPP 2-SF* 
Section and Topic 
Item description 
1. Aim of the PPI 
The project “Pseudophakic vision and lifestyle changes after bilateral 
implantation of Toric versus non-Toric intraocular lenses in Cataract patients 
with astigmatism” is a RCT comparing the effect on dynamic balance, vision 
function and quality of life changes between Toric intraocular lens versus 
(IOLs) conventional monofocal non-Toric IOLs used in cataract surgery.  
The aim of the PPI is to obtain comment from cataract patients and general 
public about the research proposals, intended outcome measures and any 
other potential practicality of the research implementation before the start of 
the research and to support research ethics application.  
2. Methods 
 
Public and Patient recruitment: 
1. Cataract patients awaiting surgery 
The optometry clinic of University of Plymouth -Centre of Eyecare Excellence 
(CEE) has been contacted to help recruiting cataract patients who has been 
referred for cataract surgery. A list of 20 patients referred for cataract surgery 
in the last six months was obtained. Ten of them had previous consent for 
further contact for research related activities. Five out of them were 
successfully recruited for this PPI. They were given a choice for an online 
group meeting or individual telephone interview and all of them preferred 
telephone interview.  

 
 
 
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2. Post-surgery cataract patient and care 
One cataract patient who recently had received multifocal IOLS for his 
cataract surgery seven weeks ago. He and his carer who worked at UOP, 
attended PPI online zoom meeting with the researcher. 
3. Community optometrist 
One community optometrist from CEE was recruited for face-to-face interview 
about the research project. 
4. Physiotherapist researcher 
One Physiotherapist researcher who had health research and PPI experience 
with Multiple Sclerosis patients was interviewed via online Zoom meeting.  
 
Contents of PPI 
During the interview, all participants were given a short description about the 
background of the project and the study design including the description of 
interventions (Toric IOLs) and control (conventional non-Toric IOLs), the 
randomization of two groups of participants, number and duration of study 
visits, what happened during the study visits, what data would be collected, 
any potential risks of intervention and assessments and who were the 
researchers. They were all offered a copy of the participant information sheets 
and consent forms to be sent via email. Discussion with participants were 
focus on the following areas: 
1. Views on the design and importance of the study 
2. Views on patients being randomly assigned to either one type of 
intraocular lens in Cataract surgery 
3. Views on assessments used study visits 
4. Views on the number, length, timing and location of study visits 
5. Views on information (PIS and consent form) for potential research 
participants 
6. Views on any other practicality of the research implementation 
7. Views on the plan of data collection and analysis 

 
 
 
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8. Views on the plan of dissemination of results 
3. Results 
 
The PPI for this project included a range of participants: five cataract patients 
who were awaiting surgery, one recent post-cataract surgery patient, one 
carer, one local community optometrist and one experienced researcher who 
has PPI and health research experience.  
 
PPI contributed to the study in several areas, including: 
 
1. Patient information:  
- 
almost all patients had not heard of Toric IOLs before. In fact, they 
reported there were not aware of different types of design of IOLs and 
had not been offered any discussions during their medical follow up. 
Only one patient who had private ophthalmologist consultation before 
was aware of Toric IOLs but chose to have non-Toric IOLs at NHS for 
financial reason. All of them felt the PIS should include details about 
what was Toric IOLs and how was it different than the conventional 
one. A few of the patients reported they were particularly interested in 
the risk and complications. 
2. Research Design and Importance.  
- 
All participants were supportive of this research project and felt it 
could provide more evidence about what Toric IOLs could offer and 
who might benefit from this type of IOLs. One participant who worked 
in visual arts said she needed perfect eyesight for work, but she was 
not given any choice about IOLS for her cataract surgery in NHS. She 
felt our research project was important as it could provide information 
for patients to make choice whether to go private for the best types of 
IOLs or to provide evidence so that NHS in the future can provide Toric 
IOLs to cataract patients.  
3. Practical consideration of the research implementation. 
 
 

 
 
 
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- 
All participants felt one pre-surgery study visit and one post-surgery 
study visit after cataract surgery were appropriate amount and the 
duration of 60 minutes was within their expectation. 
- 
The planned post-surgery visit was within 6 months after the surgery. 
The patient who had recent cataract surgery reported he was able to 
resume his normal daily activities about a week after the surgery and 
felt it was safe for the post-surgery study visits to take at 3-6 months 
after the surgery. The community optometrist also reported most 
complications such as eye infection or wound complication happened 
in the first month after the surgery and agreed it was appropriate to 
arrange post-surgery study visit for 3-6 months afterwards. 
- 
All participants in this PPI were local and they all know where the 
Plymouth Marjon University are and had no concerns about taking 
transport (bus or taxi) or having friends or family to drop off/pick up 
from there. They all reported this study site was much preferable than 
hospital site especially due to current COVID situation.  
- 
All participants said they would participate in such research project.  
Although they would not expect any monetary support but felt there 
were other patients who would be put off due to extra cost and time 
needed for participation. When mentioned there would be about £20 
travel subsidy and they all felt it was enough amount to support 
commuting or parking.   
- 
The health researcher suggested to simplify the subsidy process 
especially the administrative procedures. She had previous experience 
with Multiple Sclerosis patients and most of them ended up not 
claiming due to too many forms to fill.  
- 
The initial plan for the study involving potential participants having 
their vision assessment at the Optometry department at PAHC building 
and movement assessment at Biomechanics lab. Although both labs 
are at Marjon Campus, but it involves two sites as the PAHC belongs to 

 
 
 
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the University of Plymouth and the Biomechanics lab belongs to the 
Plymouth Marjon University. The Physiotherapist researcher who are 
academic staff of the University of Plymouth suggested it was possible 
to share the biomechanics practical room (FF22) to conduct the 
movement assessment to reduce the number of sites and travelling for 
patients. 
- 
Eyedrop use of eyedrops is not a worry for all PPI patients but will be 
helpful to have a consistent advice with local optometry and REI. A 
copy of post eyedrop care was obtained from the CEE. 
 
4. Review and communicate the research 
- 
All participants welcomed the idea of a separate WhatsApp group or 
email newsletter to maintain contact and keep update about the 
research progress. 
- 
The physiotherapist researcher shared her experience of reducing 
dropout rate especially when the study duration is long. She said 
simple update information such as update of number of participants, 
upcoming events or care advice could really help with group retention 
and future PPI. 
4. Discussion 
 
Following the PPI, the search team had two follow up meetings to discuss the 
feedback from the participants and any modification needed for the research 
protocol and patient information. A draft of PPI summary was produced and 
reviewed during the meeting. 
5. Reflection 
 
Actions to be taken following the PPI are summarized as below: 
1. Update on the participant information sheet to expand on explanation 
of what Toric IOLs are and their potential risk. 
2. Update the advice about post eyedrop care to be consistent with the 
Royal Eye Infirmary of UNPNT and CEE of University of Plymouth. No 
driving and operation of heavy machine after the pupil dilating 

 
 
 
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eyedrop and patients should either take public transport or have 
someone to drive them to and from the study visit appointments. 
3. To arrange the dynamic balance assessment at the same building 
(PAHC) as the visual assessment instead of using Marjon Biomechanics 
lab to reduce number of study sites and to reduce the amount of 
walking required by patients during study visits. 
4. Post-surgery study visit to be arranged at 3 to 6 months instead of 
after 6 months after second eye surgery 
 
*GRIPP2 short form (Staniszewska et al., 2017) 
The GRIPPS-SF is an international, evidence based, community consensus informed guidelines for the 
reporting of patient and public involvement (PPI) in research. It aims to provide a consistent and high 
quality of reporting in PPI. GRIPP2 is available in long form and short form. The short form (GRIPPP2-
SF) has been used for this project as the PPI is not the focus of this research project. 
 
References: 
BLACK, A. & WOOD, J. 2005. Vision and falls. Clinical and Experimental Optometry, 88, 212-222. 
BRIAN, G. & TAYLOR, H. 2001. Cataract blindness: challenges for the 21st century. Bulletin of the 
World Health Organization, 79, 249-256. 
FAUL, F., ERDFELDER, E., LANG, A. G. & BUCHNER, A. 2007. G*Power 3: a flexible statistical 
power analysis program for the social, behavioral, and biomedical sciences. Behav Res 
Methods, 39, 175-91. 
FOSTER, A. 2001. Cataract and “Vision 2020—the right to sight” initiative. British Journal of 
Ophthalmology, 85, 635. 
JOHNSON, L., SUPUK, E., BUCKLEY, J. G. & ELLIOTT, D. B. 2013. Effects of induced astigmatism 
on foot placement strategies when stepping onto a raised surface. PLoS One, 8, e63351. 
KESSEL, L., ANDRESEN, J., TENDAL, B., ERNGAARD, D., FLESNER, P. & HJORTDAL, J. 2016. 
Toric Intraocular Lenses in the Correction of Astigmatism During Cataract Surgery: A 
Systematic Review and Meta-analysis. Ophthalmology, 123, 275-286. 
KHAN, M. I. & MUHTASEB, M. 2011. Prevalence of corneal astigmatism in patients having routine 
cataract surgery at a teaching hospital in the United Kingdom. J Cataract Refract Surg, 37, 
1751-5. 
KHANDELWAL, S. S., JUN, J. J., MAK, S., BOOTH, M. S. & SHEKELLE, P. G. 2019. Effectiveness of 
multifocal and monofocal intraocular lenses for cataract surgery and lens replacement: a 
systematic review and meta-analysis. Graefe's Archive for Clinical and Experimental 
Ophthalmology, 257, 863-875. 
LAURENDEAU, C., LAFUMA, A. & BERDEAUX, G. 2009. Modelling lifetime cost consequences of 
toric compared with standard IOLs in cataract surgery of astigmatic patients in four European 
countries. J Med Econ, 12, 230-7. 
LORD, S. R. 2006. Visual risk factors for falls in older people. Age Ageing, 35 Suppl 2, ii42-ii45. 

 
 
 
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LORD, S. R., SMITH, S. T. & MENANT, J. C. 2010. Vision and falls in older people: risk factors and 
intervention strategies. Clin Geriatr Med, 26, 569-81. 
MANCINI, M., HORAK, F. B., ZAMPIERI, C., CARLSON-KUHTA, P., NUTT, J. G. & CHIARI, L. 2011. 
Trunk accelerometry reveals postural instability in untreated Parkinson's disease. 
Parkinsonism Relat Disord, 17, 557-62. 
MONACO, G. & SCIALDONE, A. 2015. Long-term outcomes of limbal relaxing incisions during 
cataract surgery: aberrometric analysis. Clin Ophthalmol, 9, 1581-7. 
READ, S. A., VINCENT, S. J. & COLLINS, M. J. 2014. The visual and functional impacts of 
astigmatism and its clinical management. Ophthalmic and Physiological Optics, 34, 267-294. 
STANISZEWSKA, S., BRETT, J., SIMERA, I., SEERS, K., MOCKFORD, C., GOODLAD, S., 
ALTMAN, D. G., MOHER, D., BARBER, R., DENEGRI, S., ENTWISTLE, A., LITTLEJOHNS, 
P., MORRIS, C., SULEMAN, R., THOMAS, V. & TYSALL, C. 2017. GRIPP2 reporting 
checklists: tools to improve reporting of patient and public involvement in research. BMJ, 358, 
j3453. 
SWAMPILLAI, A. J., KAABNEH, A. K., HABIB, N. E., HAMER, C. & BUCKHURST, P. J. 2020. 
Efficacy of toric intraocular lens implantation with high corneal astigmatism within the United 
Kingdom’s National Health Service. Eye, 34, 1142-1148. 
VISSER, N., BAUER, N. J. & NUIJTS, R. M. 2013. Toric intraocular lenses: historical overview, patient 
selection, IOL calculation, surgical techniques, clinical outcomes, and complications. Journal of 
Cataract & Refractive Surgery, 39, 624-637. 
WILKINS, M. R., ALLAN, B. & RUBIN, G. 2009. Spectacle use after routine cataract surgery. Br J 
Ophthalmol, 93, 1307-12. 
 
 
 
 

 
 
 
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16.6  Appendix 5 – Amendment History 
Amendment 
No. 
Protocol version 
no. 
Date issued 
Author(s) 
of 
changes 
Details of changes made 
 
V1.0. April 2022 
11th April 2022