Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery: A Randomised Trial
Phase: NA
Conditions: Cornea, Astigmatism, Cataract
Sponsor: Moorfields Eye Hospital NHS Foundation Trust

06.02.2009 
 
An exploratory randomised controlled clinical trial comparing a multifocal toric 
intraocular lens with standard multifocal lens plus incisional astigmatic 
surgery in patients undergoing bilateral cataract surgery 
 
 
 
 
 
Version 1.2 
 
Study Protocol 
 
 
 
 
 
 
 
 
 
 
Principal Investigator: 
Vincenzo Maurino, MD 
 
 
Clinical Trial Centre: 
Moorfields Eye Hospital 
Cataract Centre at St. Ann’s 
London 
 

 
2 / 16 
 
Study Synopsis 
 
Title 
Toric Multifocal intraocular lens Vs non toric  multifocal lens combined 
with incisional astigmatic surgery in patients undergoing bilateral cataract 
surgery. 
 
Investigators 
Vincenzo Maurino, MD 
Oliver Findl, MD 
Vinod Gangwani MRCOphth 
Moorfields Eye Hospital, City Road, London EC1V 2PD. 
Tel. +442075662055  Fax. +442031160190     
email: Vincenzo.Maurino @moorfields.nhs.uk 
 

 
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Background 
Spectacle independence is a central aim in modern cataract surgery. 
Although bilateral monofocal IOL implantation, aiming for emmetropia or 
low myopia, leads to high levels of patient satisfaction in distance vision, 
spectacle dependence for reading and other near vision tasks is the usual 
result. One technique available to surgeons to reduce spectacle 
dependence is to use multifocal IOL. With increasing demands for 
complete spectacles independence from patients after cataract surgery, 
multifocal IOLs  have been  introduced widely in cataract surgery. This 
should result in less spectacle dependence for patients.  
Residual astigmatism after cataract surgery can influence the post 
operative outcome of multifocal IOLs and lead to to poor visual 
performance of the multifocal lenses. Hence it is important to correct the 
astigmatism during cataract surgery to get the optimal result with 
Multifocal IOLs. Currently patients with high degrees of corneal 
astigmatism are denied multifocal lenses and in patients with low degrees 
of corneal astigmatism the option offered  is attempting to correct the 
corneal astigmatism with corneal incisional surgery such as limbal 
relaxing incisions. 
Combining a multifocal optic with a toric optic that corrects corneal 
astigmatism, so called multifocal toric lenses would correct the corneal 
astigmatism more precisely and therefore make the patient as much as 
possible spectacle independent. Results with toric IOLs (without a 
multifocal component) have achieved very good astigmatic control. 
Precise alignment of the cylindrical axis of the IOL with the astigmatic axis 
of the cornea is key for success.  
The alternative method to reduce corneal astigmatism as part of cataract 
surgery is to make relaxing incisions (cuts) on the steeper axis of the 
cornea. This technique is in use since more than 2 decades and is widely 
used in clinical routine. As with toric IOLs, precise alignment of the cuts 
with the axis of astigmatism is essential. The disadvantage of the 
incisional techniques is the variability of the effect between patients since 
it depends on factors such as the extent of scarring of the cuts after 
surgery as well as corneal thickness and shape. Also, there may be a 
tendency for regression of the effect during the first 9 months after 
surgery. Furthermore there is a small risk of infection of the corneal 
incision and microbial keratitis after limbal relaxing incision has been 
described. The main advantage is the low cost. 
 
 
 
 
 
 
 
 
 
 
 
 

 
4 / 16 
 
Study objectives 
Purpose of the present study is to compare the outcome of multifocal toric 
intraocular lens with standard multifocal lens plus incisional surgery in 
patients undergoing bilateral cataract surgery 
Study design 
Randomised controlled trial with intra-patient comparison 
 
Study population 
60 eyes (30 patients) with cataract and corneal astigmatism of 1.00 to 
2.50 D 
 
Investigational Product 
(Medical Device) 
 
First eye to be operated: 
Multifocal toric IOL (Rayner, UK), or LRI with 600µm knife according to 
the Donnenfeld nomogram + Multifocal IOL (Rayner, UK). 
The contralateral eye will receive the alternative treatment 
Main outcome variables 
 
• 
Composite scoring of unaided distance and near vision 
(monocularly) 
• 
Residual astigmatism evaluation by Subjective Refraction and 
autorefraction (Topcon)  
• 
Any intraoperative or postoperative complications 
 
 
Additional outcome 
variables 
 
Simulated K-readings using corneal topography (Pentacam) 
Rotational stability of the IOL - angle of axis as measured from 
retroillumination photographs: Orientation [degrees] 
• 
Dysphototpsia and satisfaction/ questionnaire - monocularly 
• 
Reading speed Salzburg reading test - monocularly 
• 
Glare testing – monocularly(Oqas) 
 

 
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1 
INTRODUCTION .................................................................................................7 
1.1 
Background........................................................................................................................................... 7 
1.2 
Rationale ................................................................................................................................................ 9 
1.3 
Risk/benefit assessment.................................................................................................................... 9 
2 
STUDY OBJECTIVE ......................................................................................... 10 
3 
INVESTIGATIONAL PLAN ............................................................................... 10 
3.1 
Design................................................................................................................................................... 10 
3.2 
Selection of study population......................................................................................................... 10 
3.2.1 
Number of subjects ......................................................................................................................... 10 
3.2.2 
Pre-study screening........................................................................................................................ 10 
3.2.3 
Inclusion criteria............................................................................................................................... 10 
3.2.4 
Exclusion criteria ............................................................................................................................. 10 
3.3 
Investigational Product (Medical Device) .................................................................................... 11 
3.3.1 
Medical Device (IOL) used in the study ....................................................................................... 11 
3.4 
Study protocol .................................................................................................................................... 11 
3.4.1 
Study Visits....................................................................................................................................... 11 
3.4.2 
Withdrawal and replacement of subjects..................................................................................... 13 
3.5 
Variables and schedule of observations ..................................................................................... 13 
3.5.1 
Outcome variables .......................................................................................................................... 13 
4 
METHODS OF EVALUATION........................................................................... 13 
4.1 
Assessment of residual astigmatism ........................................................................................... 13 
4.2 
Assessment of corneal astigmatism ............................................................................................ 13 
4.3 
Assessment of visual acuity........................................................................................................... 14 
4.4 
Assessment of IOL position and rotation.................................................................................... 14 
4.5 
Data handling procedures ............................................................................................................... 15 

 
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     4.5.1 
Data 
Management…………………………………………………………………………………….11 
4.6 
Biometric methods............................................................................................................................ 15 
4.6.1 
Biometric methods - outcome variables....................................................................................... 15 
4.6.2 
Biometric methods - Adverse events/Safety investigations...................................................... 15 
4.7 
Data Analysis & Use of study findings......................................................................................... 15 
 
 

 
7 / 16 
 
 
1 
Introduction 
1.1 
Background 
             Spectacle independence is a central aim in modern cataract surgery. Although bilateral 
monofocal IOL implantation, aiming for 0.00 to -0.50D, leads to high levels of patient 
satisfaction, spectacle dependence for reading and other near vision tasks is the usual result. 
Most surgeons faced with a patient with bilateral cataract would leave them either emmetropic 
or with very low levels of post-operative myopia in both eyes. This leaves most patients 
dependant on spectacles for near visual tasks. 
One technique available to surgeons to reduce spectacle dependence is to  use a multifocal 
IOL. Recent diffractive IOL designs have improved spectacle independence while reducing 
the glare phenomena(1)(6). A European study of the Restor diffractive IOL found that 74.4% 
never wore spectacles, glare and haloes occurred in 8.5% and 4.2% of patients respectively 
and 95.7% of patients said that they would have the same implant again(2). Only one patient 
out of 127 had the IOL explanted because of glare and haloes. FDA data for the Restor 
reported a spectacle independence figure of 80% (www.fda.gov/cdrh/pdf4/p040020.html). 
Bilateral implantation with contemporary multifocal lens implants reduce spectacle 
dependence and is well tolerated; but it involves compromise for the quality of distance vision. 
Residual astigmatism after cataract surgery can influence the post operative outcome and 
lead to poor performance of these lenses (3). Hence it is important to correct the astigmatism 
during cataract surgery to get the optimal result with Multifocal IOLs. The options available to 
correct astigmatism is either to implant a multifocal toric IOL or make limbal relaxing incisions 
combined with a multifocal IOL. 
 
With increasing demands of patients concerning refractive outcome after cataract surgery, 
toric IOLs that correct corneal astigmatism have been introduced more widely to cataract 
surgery. Originally toric IOLs were used mainly for patients with high degrees of astigmatism, 
especially after corneal surgical procedures such as penetrating keratoplasties. Recently, toric 
IOLs are available from numerous manufacturers to correct lower amounts of astigmatism 
which are much more prevalent. This should result in less spectacle dependence of patients 
due to the precise nature of the astigmatic correction (4).  
The new multifocal toric lenses combine the separate optical features of a standard multifocal 
lens and the toric lens to provide a superior multifocal outcome with precise and sustainable 
toric correction. 
 
The alternative method to reduce corneal astigmatism as part of cataract surgery is to make relaxing 
incisions (cuts) on the steeper axis of the cornea. This technique is in use since more than 2 decades 

 
8 / 16 
 
and is widely used in clinical routine(5). As with toric IOLs, precise alignment of the cuts with the axis 
of astigmatism is essential. Nomograms for these astigmatism correcting incisions are available 
depending on the extent and the orientation of astigmatism and the age of the patient. The 
disadvantage of the incisional techniques is the variability of the effect between patients since it 
depends on factors such as the extent of scarring of the cuts after surgery as well as corneal 
thickness and shape. Also, there is a tendency for regression of the effect during the first 9 months 
after surgery. Furthermore there is a risk of infection of the corneal incision and microbial keratitis after 
limbal relaxing incision has been described. The main advantage is only the low cost. 
 
Concerning alignment, the axis is defined by either corneal keratometry or topography, or both. 
Misalignments may be caused intra- or postoperatively. Intraoperatively, misalignment may happen 
due to cyclotorsion of the eye in the lying position or due to local anaesthesia, and due to imprecision 
of positioning of the IOL in the bag or of placing the astigmatism correcting incisions on the cornea. 
These imprecisions can be dealt with by preoperative marking of the eye in the sitting position and use 
of meticulous positioning of the IOL or incisions during surgery.  
 
A Rayner single-piece open-loop IOL made of hydrophilic acrylate was shown to have a good haptic 
memory and is thought to adhere to the capsule resulting in little to no rotation after surgery. A toric 
optic design has been added to this multifocal IOL design.  
One of the front and back surfaces of the lens defines a toric surface for an astigmatic optical 
correction, and one of the front and back surfaces, which can be the same surface or the opposite 
surface, defines a multifocal surface for a presbyopic optical correction, to provide visual acuity for 
astigmatic presbyopes 
 
There is currently a study being conducted at Moorfields Eye Hospital comparing monofocal lenses 
with LRI surgery versus toric monofocal lenses. However this does not compare with the current 
proposal as in multifocal IOL surgery astigmatism control is definitively more important than in 
monofocal IOL surgery. The presence of residual postoperative astigmatism after multifocal IOLs 
cataract surgery is not advisable and most of the companies making multifocal IOLs advise not to 
operate on patients with more than 2.00 diopters of astigmatism and advocate minimizing astigmatism 
by means of incisional corneal surgery at the time of the cataract surgery. 
Residual post-operative astigmatism leads to poor performance of multifocal lenses. One reason is 
that multifocal IOLs do reduce significantly contrast sensitivity especially in some light condition and 
adding astigmatism does have a negative impact in further reducing contrast sensitivity. Furthermore, 
the presence of astigmatism makes the multifocal generated near , intermediate and distance images 
more blurred and thus makes the brain process of learning to focus on a given image for near, 
intermediate and distance much more difficult for the patient. 
 

 
9 / 16 
 
Toric multifocal IOLs are the latest multifocal IOLS generation and do have the huge 
potential of massively improve the outcome of multifocal IOL surgery hence the relevance of 
this exploratory study. Finally whilst a monofocal toric IOL does have only a toric surface the 
multifocal toric IOL does have a more complex construction incorporating the multifocal and 
toric surfaces on one single IOL and hence comparison in terms of astigmatism reduction 
between the monofocal and multifocal IOLs may not be meaningful since a new variability is 
introduced with the multifocal toric IOL. 
 
 
 
We plan to compare the visual performance and outcome of the  non toric multifocal IOL combined 
with corneal incisional surgery to correct astigmatism with a toric multifocal IOL alone. 
 
 
 
1.2 
Rationale 
To assess the efficacy of multifocal IOL with corneal pre-existing astigmatism and compare the 
outcomes of a multifocal toric IOL or a standard multifocal IOL combined with limbal relaxing incisions. 
 
1.3 
Risk/benefit assessment 
Safety: both IOL used are CE approved and toric monofocal is well estabilished already .  One 
of the major problems of all studies with multifocal IOL is astigmatism correction. Hence the 
incorporation of toric component to the multifocal IOL should result in a better performance of 
the multifocal IOL in patients with corneal astigmatism. 
 
The investigation will show whether multifocal toric IOLs are superior to corneal incisional 
surgery plus standard multifocal IOL that is readily used in clinical practise, in correcting  
astigmatism in patients with age-related cataract. This study will also show if correction of 
astigmatism with a toric mutifocal IOL leads to better visual performance of the multifocal IOL. 
Since the IOL design studied is well known and has a long track record in the non-toric 
variant, and the non-invasive measuring procedures in this study are well tolerated, the 
benefit/risk ratio is acceptable. The contra lateral eye will receive limbal relaxing incisions with 
the multifocal IOL in the non-toric form. Since only patients that have low to moderate 
astigmatism are included in the trial, the difference in outcome should be small enough to 
ensure that the postoperative difference in residual astigmatism is small enough to not 
compromise binocular vision. 
 

 
10 / 16 
 
2 
Study objective 
Purpose of the present study is to compare efficacy of multifocal IOL after correction of 
astigmatism with either implanting a multifocal toric IOL or implanting a standard multifocal 
IOL combined with limbal relaxing incisions. 
 
 
3 
Investigational plan 
3.1 
Design 
Randomised controlled trial with intra-patient comparison (bilateral study) 
 
3.2 
Selection of study population 
The participants will be selected by the clinical investigators 
3.2.1 
Number of subjects 
60 eyes of 30 patients with bilateral cataract. 
 
3.2.2 
Pre-study screening 
The following examination will be carried out in each patient before cataract surgery: 
- 
A full ophthalmic examination including slit lamp biomicroscopy and retinal examination. 
3.2.3 
Inclusion criteria 
- 
Bilateral cataract and be planning to have both eyes operated on. 
- 
Age 21 and older 
- 
Have cataracts that allow IOL master biometry 
- 
Regular corneal astigmatism 1.00 up to 2.50 D  
- 
Difference of corneal astigmatism in both eyes to be equal to or less than 0.75D 
- 
written informed consent to surgery and participation in the study 
- 
Speak English 
 
 
3.2.4 
Exclusion criteria  
Any of the following will exclude a subject from the study: 
- 
Relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic 
cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. 
Marfan syndrome) 

 
11 / 16 
 
- 
Irregular corneal astigmatism on Pentacam topography 
Surgery should be : 
- 
Performed by consultants 
- 
Second eye to be listed within 3-4 weeks whenever possible. 
 
 
3.3 
 Investigational Product (Medical Device) 
The investigator will dispense the investigational product only to subjects included in this 
study. 
All IOL supplies will be stored in accordance with the manufacturers' instructions. 
Details of the exact date of IOL implantation will be documented in the case report form. 
 
3.3.1 
 Medical Device (IOL) used in the study  
Toric Multifocal IOL (Rayner) – Model M-Flex T 588 or 638 - CE marked since January 2007 
Non-toric Multifocal IOL (Rayner) – Model M-Flex 630F - CE marked since 2006 (in routine 
use) 
 
3.4 
Study protocol 
The study will be performed at the Moorfields Cataract Centre, St. Ann’s outreach, London. 
3.4.1 
Study Visits   
On the day of pre-operative examination, the patient will undergo a full ophthalmic 
assessment and routine biometry is performed using the IOL Master by Zeiss for axial length 
measurement and K-readings. Additionally, a corneal topography (Pentacam) will be 
performed. The software for calculating the toric power is supplied by the manufacturer 
Rayner. The most appropriate of the available toric powers of the IOL will be used. 
 
Surgery is performed under topical anaesthesia. Preoperatively, the horizontal meridian will be 
marked in the sitting position with a blue marking pen or insulin syringe at the limbus. The 
temporal 
self 
sealing 
incision, 
injection 
of viscoelastic substance, capsulorhexis, 
phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic 
substance into the capsular bag are performed as standard procedure. According to 
randomisation, the multifocal toric IOL will implanted or corneal limbal relaxing incisions (LRI) 
according to the Donnenefeld nomogram will be performed combined with standard multifocal 
IOL. 
 
The IOL is implanted via injector into the capsular bag. Following the implantation of the IOL, 
the toric axis is positioned in the planned axis by rotating the IOL. Then the viscoelastic 

 
12 / 16 
 
substance is aspirated thoroughly from the eye. 
 
The LRI eye will receive a temporal or an on-axis incision with limbal relaxing incision with a 
600µm single-use steel blade combined with a non-toric multifocal IOL. The location, length 
and site of LRIs will be made after calculation according to the Donnenfeld nomogram 
(www.lricalculator.com).  
 
Extra trial visit 
           3-4 months after the second eye has been operated on. 
 
 
Follow-up examinations are performed as depicted in the table: 
 
Assessments/Examinations 
Visit 0 
Visit 1 
Visit 2       Visit 3 
 
 
 
 
PreOp 
Op day 
(after 1 hr) 
1 month   3 months 
 
Autorefractor 
X 
 
X           X 
 
Subjective Refraction 
 
 
             X 
 
Near, Distance  VA 
 
 
X          X 
 
IOL Master Keratometry 
X 
 
X          X 
 
Topography (Pentacam) 
X 
 
X         X 
 
 
 
 
 
 
Retroillumination photo 
 
X 
  X        X 
 
Slitlamp examination 
X 
X 
X        X 
 
Dysphototpsia and 
satisfaction questionnaire 
 
 
             X 
 
Reading speed(Salzburg 
reading test) 
 
 
              X 
 
Contrast Vision(Pelli Robson 
chart) 
 
 
              X 
 
Glare testing(oqas) 
 
 
               X 
 
 
Postoperative standard medication: dexamethasone gtt, qid for 2 weeks and then bid for one 
week, chloramphenicol gtt qid for 2 weeks 
 
 

 
13 / 16 
 
3.4.2 
Withdrawal and replacement of subjects 
Subjects must be withdrawn under the following circumstances: 
- 
at their own request 
3.5 
Variables and schedule of observations 
3.5.1 
Outcome variables 
Main outcome variables 
 
• 
Composite scoring of unaided distance and near vision 
(monocularly and binocularly) 
• 
Residual astigmatism evaluation by Subjective Refraction and 
autorefraction (Topcon) and  
• 
Any intraoperative or postoperative complications 
 
 
Additional outcome 
variables 
 
Simulated K-readings using corneal topography (Pentacam) 
Rotational stability of the IOL - angle of axis as measured from 
retroillumination photographs: Orientation [degrees] 
• 
Dysphototpsia and satisfaction questionnaire - monocularly 
• 
Reading speed Salzburg reading test - monocularly 
• 
Glare testing (Oqas)– monocularly 
• 
Post-operative dominance will be established using the visual 
acuity results to ensure that there are equal numbers of dominant 
and non-dominant eyes in both groups 
 
4 
Methods of evaluation 
4.1 
Assessment of residual astigmatism 
Measurement of residual astigmatism will be derived from autorefraction with an autorefractor 
(Topcon) with mean reading of 5 consecutive measurements in IOL mode, a subjective 
refraction by an optometrist using trial lenses and the cross cylinder method. All these 
measurements are non-invasive, non-contact and readily used in daily clinical practice. 
 
4.2 
Assessment of corneal astigmatism 
Measurement of corneal astigmatism before and after surgery will be performed using the 
autokeratometry function of the IOL-Master (Zeiss) and the Scheimpflug technique 

 
14 / 16 
 
(Pentacam, Oculus). In the latter case, the simulated K-readings of the central 4 mm zone will 
be used. 
 
4.3 
Assessment of visual acuity 
Measurement of uncorrected and best corrected visual acuity will be done using a back-lit 
EDTRS chart placed at 4m. 
Near and distance  unaided and corrected visual acuity will be measured  
 
Reading speed, reading acuity and ciritical print size monocularly (Salzburg Reading 
Desk)  
The Salzburg Reading Desk (SRD) is the prototype of a reading chart that measures 
reading speed and reading distance. Contrast and light conditions are preset and reading 
distance (+/- 0.2 cm), reading speed and their changes during the examination are 
measured. This ensures an objective evaluation of measurements under the same 
conditions at every follow-up.  
 
 
Contrast vision under photopic and mesopic conditions (Pelli-Robson Chart) 
 
Glare testing monocularly by Oqas: 
The OQAS system consists of laser diagnostic sensory equipment, a computer workstation 
and custom designed software. It works by sending in an infrared light source and directly 
measuring the point spread function (PSF) of the optical system of the eye. Because OQAS 
measures all light reflected back off the retina, the measurement contains the effects of light 
scatter and all high order abrrations. 
 
 
Dysphotopsia and satisfaction questionnaire – comparing the visual quality of the eyes as 
assessed under different conditions – to be filled in by patients at home shortly before the 3 
months follow-up (see attachment) 
 
4.4 
Assessment of IOL position and rotation 
IOL axis measurements are assessed from photos attained with a high-resolution digital 
retroillumination imaging system. The optical system consists of a Zeiss 120 slit-lamp for 
observation and imaging. A Zeiss retrolux illumination module is supplied with illumination 
provided by a Zeiss anterior segment flashpack through a fiber optic cable. For image 
acquisition we use a colour digital camera (Canon D5). The main advantage of this camera is 
the high light sensitivity of the large CCD chip, resulting in a high signal-to-noise ratio in the 

 
15 / 16 
 
acquired images. The images are directly transferred to a personal computer and saved to 
hard-disc. The images are assessed using a dedicated analysis software. 
 
The axis marks are identified with a cursor and the axis of the IOL is registered. In order to 
ensure consistent alignment of the patient’s head at each follow-up, the patient’s head will be 
positioned as straight as possible according to the examiners subjective impression. A pilot 
study has shown this to be reproducible to about 2° concerning axis documentation. 
 
4.5 
Data handling procedures 
A case record form will be completed for each patient. The entries will be checked by trained 
personnel and any errors or inconsistencies will be checked immediately. 
 
4.5.1 
Data Management 
 
 
All data will be entered into a specially designed ACCESS database by the  
 
Research Fellow.  This database will be on the H drive of Moorfields Eye  
 
 
Hospital intranet and will be password protected and only accessible by  
 
 
authorised personnel. 
4.6 
Biometric methods 
4.6.1 
Biometric methods - outcome variables 
The outcome variables will be assessed using descriptive statistics. 
4.6.2 
Biometric methods - Adverse events/Safety investigations 
All adverse events will be properly listed and an appropriate method will be used to 
summarise the data. 
4.7 
Data Analysis and Use of study findings 
We propose to generate a composite measure with 4 categories based on measures of 
distance and near visual acuity, but will use this pilot data (with patient questionnaire data) to 
determine how best to do this.   
 
Components of the Visual Scoring System 
 
 
A 
B 
C 
D 
 
Excellent 
Good 
Average 
Poor 
Distance VA  
(log mar) 
0.0 or better 
ie. 6/6 or better
<0.0 to 0.18 
ie. 6/6 to 6/9 
<0.18 to 0.30 
ie. <6/9 to 6/12 
<0.30  
ie. <6/12 
Near VA  
 
N5 or better 
<N5 toN6 
<N6 to N8 
<N 8 

 
16 / 16 
 
 
The findings of this pilot study will be published by the investigators in a scientific journal and 
presented at scientific meetings, and will be used to power a full-scale randomised controlled 
trial.  
 
4.8 
Benefits and Risks 
Patients will have the opportunity to take part in a project that offers them the chance to be 
spectacle independent. The risks to the patients above those of the surgery itself will come 
from intolerance of whichever treatment arm they are randomised to. These risks are low, The 
European study of diffractive IOLs found that 74.4% never wore spectacles, glare and haloes 
occurred in 8.5% and 4.2 % respectively and 95.7 % of patients said they would have the 
same implant again (2).  
Where a patient is intolerant of the multifocal IOL they will be offered bilateral sequential IOL 
exchange with monofocal implants. Any  further refractive surgery(7) required (e.g. residual 
bothersome astigmatism) will be performed if needed and after risks/benefit explanation and 
the costs will be met by the company sponsoring the trial (Rayner).  In addition, Rayner 
Intraocular Lenses Ltd have agreed to supply all the lenses required for this trial free of charge 
and have agreed a small unrestricted grant of upto £5,000 to cover the costs of the study. 
 
 
References: 
 
1. 
Davison JA, Simpson MJ, History and development of apodized diffractive intraocular 
lens. J Cataract Refract Surg 2006; 32: 849-58 
2. 
Kohnen T, Allen D, Boureau C, et al. European multicentre study of acrysof ReSTOR 
apodized diffractive intraocular lens. Ophthalmology 2006; 113: 584 
3. 
Hayashi K, Hayashi H, et al. Influence of astigmatism on multifocal and monofocal 
intraocular lenses. Am J Ophthalmol. 2000 Oct;130(4):477-82 
4. 
Bauer NJ, de Vries NE, et al. Astigmatism management in cataract surgery with the 
AcrySof toric intraocular lens. J Cataract Refract Surg. 2008 Sep;34(9):1483-8 
5. 
Müller-Jensen K, Fischer P, Siepe U. Limbal relaxing incisions to correct astigmatism in 
clear corneal cataract surgery. J Refract Surg. 1999 Sep-Oct;15(5):586-9. 
6. 
De Vries NE, Webers CA, et al. Long-term follow-up of a multifocal apodized diffractive 
intraocular lens after cataract surgery. J Cataract Refract Surg. 2008 Sep;34(9):1476-82. 
7. 
Jendritza BB, Knorz MC, Morton S. Wavefront-guided excimer laser vision correction 
after multifocal IOL implantation. J Refract Surg. 2008 Mar;24(3):274.