Examination of New Visual Acuity and Clinical Crowding Tests for Better Detection of Amblyopia
Phase: NA
Conditions: Amblyopia
Sponsor: Anglia Ruskin University

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
i
 
 
 
 
 
 
 
 
HRA Protocol Compliance Declaration 
 
This protocol has regard for the HRA  
guidance and order of content 
 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
ii
 
 
 
AN EXAMINATION OF NEW VISUAL ACUITY AND CROWDING DISTANCE TESTS, 
FOR BETTER DETECTION OF AMBLYOPIA. 
 
 
New visual acuity and crowding tests for better detection of amblyopia. 
 
 
 
PROTOCOL VERSION NUMBER: 5.0 
DATE: 17/02/2021 
 
 
 
IRAS Number: 238449 
 
Sponsor number: FST/FREP/17/739 
 
 
  
 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
iii 
SIGNATURE PAGE 
 
The undersigned confirm that the following protocol has been agreed and accepted and that 
the Chief Investigator agrees to conduct the study in compliance with the approved protocol 
and will adhere to the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, 
and other regulatory requirement. 
I agree to ensure that the confidential information contained in this document will not be 
used for any other purpose other than the evaluation or conduct of the investigation 
without the prior written consent of the Sponsor. 
I also confirm that I will make the findings of the study publically available through 
publication or other dissemination tools without any unnecessary delay and that an honest 
accurate and transparent account of the study will be given; and that any discrepancies 
from the study as planned in this protocol will be explained. 
 
For and on behalf of the Study Sponsor: 
 
Signature: .................................................................................... 
Date: ....../....../...... 
Name (please print): 
.......................................................................................................  
 
Position: ........................................................................................  
 
 
Chief Investigator: 
Signature: .................................................................................... 
Date: ....../....../...... 
Name: (please print): 
...................................................................................................... 
 
 
 
 
Research Supervisor: 
Signature: .................................................................................... 
Date: ....../....../...... 
Name: (please print): 
...................................................................................................... 
 
 
 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
iv 
 
 
LIST OF CONTENTS 
 
GENERAL INFORMATION 
Page No. 
HRA PROTOCOL COMPLIANCE DECLARATION  
i 
TITLE PAGE 
 
ii 
RESEARCH REFERENCE NUMBERS 
 
ii 
SIGNATURE PAGE 
iii 
LIST OF CONTENTS 
 
iv 
KEY STUDY CONTACTS 
v 
STUDY SUMMARY 
vii 
FUNDING 
 
ix 
ROLE OF SPONSOR AND FUNDER 
xi 
ROLES & RESPONSIBILITIES OF STUDY STEERING GROUPS AND INDIVIDUALS  
 
xiii 
STUDY TIMELINE AND FLOW CHART  
xviii 
SECTION  
1. BACKGROUND 
 
1 
2. RATIONALE  
5 
3. THEORETICAL FRAMEWORK 
10 
4. RESEARCH QUESTION/AIM(S)  
11 
5. STUDY DESIGN/METHODS AND DATA ANALYSIS 
13 
6. STUDY SETTING 
25 
7. SAMPLE AND RECRUITMENT 
27 
8. ETHICAL AND REGULATORY COMPLIANCE (inc confidentiality and risk) 
32 
9. DISSEMINATION  POLICY 
43 
10. REFERENCES 
45 
11. APPENDICES 
52 
  
 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
v 
KEY STUDY CONTACTS 
Principal Investigator 
Louisa Haine – Postgraduate Researcher 
COS 407; Anglia Vision Research, 
Department of Vision and Hearing Sciences, 
Faculty of Science and Technology, 
Anglia Ruskin University, 
Cambridge 
CB1 1PT 
Phone: 01223 698584 
Email: louisa.haine@aru.ac.uk  
 
Chief Investigator / Research 
Supervisor  
(Study Co-ordinator) 
Dr Sarah Waugh – Reader in Vision Sciences 
Department of Optometry and Vision Sciences,  
University of Huddersfield 
HD1 3DH 
Phone: 01484 422288 
Email: s.j.waugh@hud.ac.uk  
 
Sponsor 
Anglia Ruskin University 
Contact on behalf of the Sponsor 
Professor Peter Bright  
Chair: FREP (Faculty of Science and Technology 
Research Ethics Panel) 
Department of Psychology, 
Faculty of Science and Technology, 
Anglia Ruskin University, 
Cambridge 
CB1 1PT 
Phone: 01223 698647 
peter.bright@aru.ac.uk 
 
Joint-sponsor(s)/co-sponsor(s)  
N/A 
 
Funder(s) 
Contact on behalf of the Sponsor/funder 
Anglia Ruskin University (via The Doctoral School)  
Dr Alan White 
Director of Doctoral School 
Research and Innovation Development Office 
Anglia Ruskin University, 
Chelmsford 
CM1 1SQ 
Phone: 01245 684957 
alan.white@aru.ac.uk 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
vi 
Key Protocol Contributors 
Louisa Haine – Postgraduate Researcher 
COS 407; Anglia Vision Research, 
Department of Vision and Hearing Sciences, 
Faculty of Science and Technology, 
Anglia Ruskin University, 
Cambridge 
CB1 1PT 
Phone: 01223 698584 
Email: louisa.haine@aru.ac.uk 
Dr Sarah Waugh – Reader in Vision Sciences, 
Dr Sarah Waugh – Reader in Vision Sciences 
Department of Optometry and Vision Sciences,  
University of Huddersfield 
HD1 3DH 
Phone: 01484 422288 
Email: s.j.waugh@hud.ac.uk  
 
Dr Monika Formankiewicz – Senior Lecturer, 
COS 204 / COS 408; Anglia Vision Research, 
Department of Vision and Hearing Sciences, 
Faculty of Science and Technology, 
Anglia Ruskin University, 
Cambridge 
CB1 1PT 
Phone: 01223698843 
Email: monika.formankiewicz@aru.ac.uk 
Fax: 01223417712 
 
Committees 
FRDSC: Faculty Research Degrees Sub-Committee 
Professor Michael Cole – Deputy Dean (Research and 
External Income) 
Chair, Faculty of Science and Technology FRDSC 
SCI 712 
Cambridge 
Phone: 01223 698525; michael.cole@aru.ac.uk  
Fax: 01223 417712 
 
FREP – Faculty Research Ethics Panel 
Professor Peter Bright 
Chair, Faculty of Science and Technology FREP 
SCI 604 
Cambridge 
Phone: 01223 698647 peter.bright@aru.ac.uk  
Fax: 01223 417712 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
vii 
STUDY SUMMARY 
Study Title 
An examination of new visual acuity and crowding distance tests for 
better detection of amblyopia. 
Internal ref. no.  
(or short title) 
New visual acuity and crowding tests for better detection of 
amblyopia. 
Study Design 
In this single centre study, assessment of three theoretical 
enhancements to visual acuity testing 1) crowding-enhanced 
letters, 2) crowded-enhanced contrast-modulated letters and 3) 
measurement of crowding distance, will be tested using clinical 
tests in a control group and in amblyopic children.  Results from 
these 3 tests will be compared to each other and to those from the 
Sonksen logMAR Test (SLT) the current clinical standard, as 
measured by a clinician.  Comparisons across test, and between 
participant groups, will enable us to determine the optimal test, or 
combination of tests, for detecting amblyopia.  Visual acuities and 
crowding distance will be measured prospectively in a randomised 
controlled trial. Results will also be obtained in a control group, a 
sample of false-positive referrals to the hospital, and compared to 
that already obtained on normal healthy children (Waugh et al., 
2018). 
The testing will take place in a clinical room neighbouring the 
ACPOS (Addenbrooke’s Community Paediatric Ophthalmology 
Service) clinic, which is hosted within the University Eye Clinic at 
Anglia Ruskin University (ARU). 
Study Participants 
Test participants; 42 Male and female, 3 to 11-year-old children 
diagnosed 
as 
having 
amblyopia 
(21 
strabismic 
and 
21 
anisometropic) by clinicians within Addenbrookes Community 
Paediatric Ophthalmology Service (ACPOS), hosted by the University 
Eye Clinic at Anglia Ruskin University (ARU) will be recruited. 
Control Participants; 21 Male and female, 3 to 11-year-old children 
who have either been falsely referred into ACPOS (Addenbrookes 
Community Paediatric Ophthalmology Service) by the national 
vision screening service, but who are subsequently found to have 
satisfactory visual function; or visually healthy volunteers who have 
already passed vision screening will be recruited. 
All participants must be able to perform the Sonksen logMAR Test 
(SLT) either verbally, or by using a matching card. 
Planned Size of Sample 
(if applicable) 
Total participant pool: n=63 
Anisometropic amblyopes n=21;  
Strabismic amblyopes n=21;  
Control group n=21. 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
viii 
Follow up duration (if 
applicable) 
This project requires one visit by each participant.  However 
participants may choose to participate more than once (up to a 
maximum of 3 times) during the recruitment and testing period 
(within the 2 year data collection period). 
 
Planned Study Period 
It is planned that recruitment and testing will take place over 2 year 
period. (See Gantt Chart for estimated project delivery dates). 
Research 
Question/Aim(s) 
 
This study aims to investigate whether proposed modifications to 
visual acuity tests will offer better sensitivity to the detection of 
amblyopia than the Sonksen logMAR test (SLT).  It will also 
determine whether differences in outcomes occur for 
anisometropic, versus strabismic amblyopes. 
 
 
 
 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
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FUNDING AND SUPPORT IN KIND 
 
FUNDER(S) 
(Names and contact details of ALL 
organisations providing funding and/or 
support in kind for this study) 
FINANCIAL AND NON FINANCIALSUPPORT 
GIVEN 
 
1) Anglia Ruskin University  
 
(via The Doctoral School)  
Dr Alan White 
Director of Doctoral School 
Research and Innovation Development 
Office 
Anglia Ruskin University, 
Chelmsford 
CM1 1SQ 
Phone: 01245 684957 
alan.white@aru.ac.uk 
 
2) Anglia Ruskin University 
via Quality Related Research Funds from 
HEFCE (Higher Education Funding Council 
for England) to FST and Anglia Vision 
Research. 
 
Professor Michael Cole 
Deputy Dean (Research and External 
Income) 
Faculty of Science and Technology 
Anglia Ruskin University 
CP1 1PT 
 
michael.cole@aru.ac.uk  
 
 
The Research Supervisor/Chief investigator 
(Dr Sarah J Waugh) has been awarded a Vice 
Chancellor’s Studentship to provide fees 
and a living stipend to support a PhD 
student, (Louisa Haine), throughout the 
course of this study. 
 
 
 
 
 
Quality Related Research Funding from 
HEFCE awarded to ARU has been approved 
for the Research Supervisor to reimburse 
participants’ parents/carers for their time 
(£10 per participation visit in the form of an 
amazon voucher) for this project. 
 
Quality Related Research Funding has been 
approved for the Research Supervisor to 
cover the cost of computer hardware and 
software required for the execution and 
analysis of data generated from this project. 
 
 
 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
x 
Contact on behalf of the Sponsor 
 
Professor Peter Bright,  
Chair of Faculty of Science and Technology Research Ethics Panel (FST FREP),  
 
Department of Psychology, 
Faculty of Science and Technology, 
Anglia Ruskin University, 
Cambridge 
CB1 1PT 
Phone: 01223698647 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
xi
ROLE OF STUDY SPONSOR AND FUNDER 
The Sponsor and the Funder for this project is Anglia Ruskin University (ARU).   
The Principle Investigator on this study is a PhD student (Louisa Haine) funded through an 
ARU Vice-Chancellor’s PhD Studentship, awarded to the Chief investigator / Research 
Supervisor (Dr Sarah J Waugh).  The award funds the PhD student’s fees and bursary.   
The study design, conduct, data analysis and interpretation, manuscript writing, and 
dissemination of results is the responsibility of the research student (The Principal 
Investigator) and the research supervisory team led by Dr Sarah J Waugh (The Chief 
Investigator /The Research Supervisor).   
The Sponsor of this project, with regards to ethics approval, is the Chair of the Faculty of 
Science and Technology Research Ethics Panel, Professor Peter Bright. 
The following relevant information with respect to student funding, the dissemination of 
research results and public engagement, has been taken from the “Anglia Ruskin University 
Vice Chancellor’s PhD Studentships Terms and Conditions 2017-18 (Ver 2.0)”. 
Tenure of the studentship  
Anglia Ruskin University expects studentship holders to maintain regular contact with their 
supervisors and other institutional authorities during the period of the award. The length of 
a studentship will not exceed three years. Continuation of all studentships is subject to the 
student’s satisfactory annual progress. Funding for a student will cease once he or she has 
submitted their doctoral thesis, or reaches the end of the stated studentship duration, 
whichever is sooner. 
 
Publication and Dissemination of Research  
It is ARU policy that the results of the research it supports should be disseminated as widely 
as possible, for the benefit of other researchers and of the wider community (however, also 
see our statement regarding intellectual property rights below).  
 
ARU has established arrangements for ensuring that these are deposited in our on-line 
repository and made available to other researchers. Students should consult their supervisors 
about those arrangements. Doctoral students should ensure that their thesis (or any other 
output such as an exhibition or performance) includes an acknowledgement of the support 
they have received from ARU.  
 
Publication of any aspect of the research resulting from an ARU-funded studentship, through 
publications and other forms of media communication, including media appearances, press 
releases and conferences, must acknowledge the support received from the ARU.  
 
Research students should discuss with their supervisors whether any or all of the results of 
their work should be published.  
If a student, or anybody else, publishes any aspect of the research resulting from an ARU 
funded studentship, through publications and other forms of printed or electronic media 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
xii 
communication, including media appearances, websites, press releases and conferences, 
they must acknowledge the support received from ARU.  
 
Learned societies and other organisations (such as the Institute of Historical Research) collect 
and publish information about doctoral theses completed and in progress. ARU strongly urges 
the submission of relevant information if asked to do so.  
 
Exploitation and Intellectual Property Rights  
ARU asserts the right to ownership of all intellectual property (IP) rights arising from research 
it funds through a VC PhD Studentship.  A student should not enter into any agreement that 
may affect rights to exploit the IP arising from their work without first consulting the Director 
of RIDO (Research and Innovation Development Office of ARU).  
 
Roles and Responsibilities for Project 
It is up to the research student (The Principal Investigator) supervised by her Research 
Supervisor (and other members of the research supervisory team) under the auspices of the 
Faculty Research Degrees Sub-committee, to contribute to an approved study design and 
proposal.  The study conduct, data analysis and interpretation, manuscript writing, and 
dissemination of results is also the responsibility of the research student (The Principal 
Investigator) in collaboration with her Research Supervisor (and other members of the 
research supervisory team) who are also in control the final decision regarding any of these 
aspects of the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
xiii 
ROLES AND RESPONSIBILITIES OF STUDY MANAGEMENT 
COMMITTEES/GROUPS & INDIVIDUALS 
Study Steering Groups                      
Information about research conducted by research students for a research degree is available 
in “Research Degrees Regulations” for Anglia Ruskin University found at: 
https://web.anglia.ac.uk/anet/academic/research_regulations.phtml . 
Brief information about relevant study management groups is provided here. 
Research Committee 
The Research Committee is responsible for the development and implementation of Anglia 
Ruskin University’s Research, Innovation and Knowledge Exchange Strategy.  
Research Degrees Subcommittee (RDSC) 
The Senate’s Research Degrees Subcommittee (RDSC) is responsible, on behalf of the 
Research Committee, for the development of research degrees in Anglia Ruskin University 
and for developing, monitoring and reviewing Anglia Ruskin University’s quality assurance 
and enhancement policies and procedures for monitoring and reviewing the quality of the 
student experience. Some of the Subcommittee’s responsibilities and procedures are 
devolved to Faculty Research Degrees Subcommittees (FRDSCs).  
Faculty Research Degrees Subcommittees (FRDSC) 
FRDSCs monitor the progress of all research degrees students within the faculty and receive 
and approve documents relating to various key stages in a student’s progress.  
This proposed study has been approved by three reviewers, two with subject-specific 
expertise, from outside the Research Supervisory Team, but within the Faculty of Science and 
Technology, Anglia Ruskin University.  The report by reviewers recommended (on 21/2/18) 
that the research proposal is approved by FRDSC, as being suitable for PhD level study.  
Approval will be ratified at the FRDSC meeting 3/5/18.  
Research Ethics Subcommittee (RESC) 
This Subcommittee of the Research Committee considers policies and procedures relating to 
the ethics of research investigations involving human participants, human tissue and organs, 
animals and other research that presents ethical issues undertaken by staff and students of 
Anglia Ruskin University. Responsibility for the approval of individual research ethics 
applications is devolved by Research Ethics Subcommittee to Faculty Research Ethics Panels.  
Doctoral Supervisors for the Proposed Study 
First Supervisor – Dr Sarah J Waugh (Anglia Vision Research) 
Second Supervisor – Dr Monika A Formankiewicz (Anglia Vision Research) 
Third Supervisor – Dr Akash S Chima (Anglia Vision Research) 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
xiv 
Doctoral supervisors (Updated – 17/02/2021) 
First Supervisor – Dr Monika A Formankiewicz (Anglia Vision Research) 
Second Supervisor – Dr Sarah Lalor (Anglia Vision Research) 
Third Supervisor – Dr Sarah J Waugh (External - University of Huddersfield) 
Advisor - Dr Akash S Chima (External – University of the Highlands and Islands) 
 
The research student and members of the research supervisory team are members of Anglia 
Vision Research, one of two research groups in the Department of Vision and Hearing 
Sciences, Faculty of Science and Technology.  Quality Related (QR) funding (HEFCE) from the 
University is distributed to researchers via Research Group within the Faculties.  Dr Monika 
Formankiewicz is the Director of Anglia Vision Research, a research group within the 
Department of Vision and Hearing Sciences, as well as the ARU Academic Lead for ACPOS 
(Addenbrooke’s Community Paediatric Ophthalmology Service).  ACPOS is the NHS 
Addenbrooke’s Hospital funded service from which this project’s participants will be 
recruited.  It is hosted within the Department of Vision and Hearing’s University Eye Clinic at 
Anglia Ruskin University. 
Role of First Supervisor (The Research Supervisor): taken from “Expectations of First 
Supervisors” https://web.anglia.ac.uk/anet/rido/docschl/info.phtml  
• To possess knowledge of key University contacts for research degree candidates and 
supervisors. 
• To provide, with other members of the supervisory team, expert guidance and advice 
to the candidate. 
• To respond promptly to all communications. 
• To provide pastoral support for candidates. 
• To communicate effectively with other members of the supervisory team. 
• To be responsible for identifying other members of the supervisory team. 
• To support the candidate in undertaking an initial assessment or revision of their 
Research Skills Training Needs Analysis. 
• To ensure that research candidates undertake a programme of skills acquisition so 
that they can demonstrate a comprehensive range of research skills as determined by 
the Joint Statement of the Research Councils. 
• To facilitate and monitor the research candidate’s progress. 
• To set objectives for the candidate to publish their research. 
Role of the Research Student (The Principal Investigator): relevant aspects taken from 
“Research Degrees Regulations” for Anglia Ruskin University found at: 
https://web.anglia.ac.uk/anet/academic/research_regulations.phtml . 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
xv
Training and Development:  Research students are required by the RDSC to attend all of the 
compulsory sessions of the Researcher Development Programme. These are designed to 
support students during their programme of research and are part of the broader researcher 
development activity offered by the Doctoral School.  
 
Stage 1 of the compulsory sessions is linked to the Research Proposal application. Stages 2a 
and 2b are linked to the application for Upgrade/Confirmation of Registration. Stage 3 is 
designed to help candidates prepare for their viva.  As part of the Stage 1 training, all students 
must pass the online module Intellectual Property in the Research Context.  
 
All candidates must complete a Research Skills Training Needs Analysis to establish their skills 
development needs and create a personal development plan. This must be updated and 
submitted each year as part of the process of Annual Review.  
 
All postgraduate research degree candidates must attend either a) Introduction to Research 
Ethics and Integrity (in Human Research) development offered by the Doctoral School or b) 
pass the online module Ethics 1 - Good Research Practice. A copy of the relevant training 
certificate must be provided to the Researcher Development Programme Administrator in the 
Doctoral School.  
 
All postgraduate research degree candidates whose research falls under risk categories 
yellow, red or purple (as determined by completing the Stage 1 Research Ethics Application 
Form), are also required to pass the online module Ethics 2 - Research with Human Subjects 
in the Health and Social Sciences or an equivalent course approved by the Chair of the 
appropriate Faculty Research Ethics Panel.  
 
Intellectual Property  
All postgraduate research degrees students are required to sign an undertaking that, in 
instances where they are formally notified as working on a project having commercial 
sponsors or commercial potential, they will enter into a confidentiality agreement, and assign 
their Intellectual Property rights to Anglia Ruskin.  
 
Research Ethics: Research students need to consider ethical issues at an early stage and 
should consult the relevant web pages for further advice:  
http://www.anglia.ac.uk/researchethics.  
A Research Proposal Ethics Checklist must be submitted with the Research Proposal. 
Submission of the checklist does not constitute applying for ethical approval, which is a 
separate process.  Approval from other entities (e.g. NHS, Ministry of Defence) is in some 
cases regarded as equivalent to our own. In cases such as the proposed study, HRA approval 
will be ratified by the Faculty of Science and Technology Research Ethics Panel (FREP). 
 
Patient & Public Involvement  
ARU encourages students and supervisors to identify and exploit opportunities for wider 
promotion of their research activities including media activities, public engagement, or 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
xvi 
knowledge transfer activities where this might be desirable or appropriate and to 
demonstrate excellence and impact. 
A previous study has been conducted by the Research Supervisor to obtain data using the 
same new visual acuity tests to be used in the proposed study, on 200 normal healthy 
children.   A selection of these results have been accepted for presentation at Vision Sciences 
Society 2018, Florida, U.S.A.  (Waugh, S. J. et al. (2018) ‘Crowding distance in healthy children’, 
in Vision Sciences Society).  This initial study has allowed for previous public involvement to 
shape the design of the proposed research project.   
The involvement of the public / patients in the proposed study will be participation during the 
testing / experimental phase.  
Participants will be able to request access to the general conclusions of the study, and the 
results will be disseminated publically at research conferences and in scientific journals. 
 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
xvii 
PROTOCOL CONTRIBUTORS 
Key Protocol Contributors; 
Louisa Haine – Postgraduate Researcher 
Cos 407, Anglia Vision Research, 
Department of Vision and Hearing Sciences, 
Faculty of Science and Technology, 
Anglia Ruskin University, Cambridge, CB1 1PT 
Phone: 01223698584 
Email: louisa.haine@aru.ac.uk  
 
Dr Sarah J Waugh – Reader in Vision Sciences, 
Department of Optometry and Vision Sciences,  
University of Huddersfield 
HD1 3DH 
Phone: 01484 422288 
Email: s.j.waugh@hud.ac.uk  
 
Dr Monika A Formankiewicz – Senior Lecturer, 
Cos 204 / Cos 408, Anglia Vision Research, 
Department of Vision and Hearing Sciences, 
Faculty of Science and Technology, 
Anglia Ruskin University, Cambridge, CB1 1PT 
Phone: 01223698843  
 
 
Fax: 01223417712 
Email: monika.formankiewicz@aru.ac.uk 
 
KEY WORDS: Amblyopia, visual acuity, crowding, anisometropia, strabismus, paediatrics.   
 
 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
xviii 
PROPOSED STUDY FLOW CHART / GANTT CHART 
 
 
 
 
Oct - Dec Jan - March Apr - June July - Sept Oct - Dec Jan - Mar Apr - June July - Sept Oct - Dec Jan - March Apr - June July - Sept
PHD RESEARCH ACTIVITY
Research proposal writing and submission
Literature Reading
Protocol writing
Ethical application writing
Ethics board meeting (NRES)
Experiment
Data analysis
Conference presentations
THESIS
Write up
Title
Literature review
Methodology
Results & data analysis
Discussion
Conclusions
Abstract
References and formatting
Proof reading, Printing and Binding
Submission of Thesis
Submit
Louisa Haine -  PGR
Year 1 (2017-2018)
Year 2 (2018 - 2019)
Year 3 (2019 - 2020)
Oct - Dec Jan - March Apr - June July - Sept Oct - Dec Jan - Mar Apr - June July - Sept Oct - Dec Jan - March Apr - June July - Sept
PHD RESEARCH ACTIVITY
Research proposal writing and submission
Literature Reading
Protocol writing
Ethical application writing
Ethics board meeting (NRES)
Experiment
Data analysis
Conference presentations
THESIS
Write up
Title
Literature review
Methodology
Results & data analysis
Discussion
Conclusions
Abstract
References and formatting
Proof reading, Printing and Binding
Submission of Thesis
Submit
Louisa Haine -  PGR
Year 1 (2017-2018)
Year 2 (2018 - 2019)
Year 3 (2019 - 2020)

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
1 
Research protocol 
Study title 
An examination of new visual acuity and crowding distance tests, for better detection of 
amblyopia. 
 
Short Study Title 
New visual acuity and crowding tests for better detection of amblyopia. 
 
Background: 
Amblyopia, or ‘lazy eye’, is defined as a reduction in visual acuity (i.e. best corrected vision) 
of one or both eyes, due to abnormal visual development during childhood without organic 
cause (Von Noorden, 1974). Undetected and untreated it leads to permanent 
neurodevelopmental visual loss (Von Noorden, 1974; Daw, 2014). It is ordinarily associated 
with anisometropia (an interocular difference in refractive error), strabismus (ocular 
misalignment) or stimulus deprivation (such as seen in individuals with congenital cataracts). 
Amblyopia is thought to be due to the disruption of the normal development of binocular 
vision early in life (Wiesel and Hubel, 1963; Rauschecker and Singer, 1981; Crawford et al., 
1983).  It is a preventable and leading cause of monocular vision loss, with a prevalence of 
around 3% (Attebo et al., 1998), and increases the lifetime risk of bilateral visual impairment 
(BVI) from 10% seen in the general population, to 18% in amblyopic individuals (van Leeuwen 
et al., 2007).  Early treatment of amblyopia is widely believed to be key to success (Epelbaum 
et al., 1993; Flynn et al., 1998, 1999; Wu and Hunter, 2006). Diagnosis of amblyopia is 
necessary for treatment to be initiated, therefore early diagnosis is important. 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
2 
Amblyopia is a diagnosis by exclusion, with its principal diagnostic criterion being a reduction 
in visual acuity (Sengpiel, 2013).  While visual acuity loss is the clinical diagnostic focus of 
amblyopia, amblyopia also affects other fundamental properties of spatial vision such as 
crowding, contrast sensitivity, hyperacuity, stereopsis and reading speed (McKee, Levi and 
Movshon, 2003; Hamm et al., 2014; Kelly et al., 2017; Birch and Kelly, 2017). Both strabismic 
and anisometropic amblyopia demonstrate reductions in visual acuity and contrast 
sensitivity, however strabismic amblyopes suffer additional spatial distortion of and abnormal 
spatial interactions between, visual targets.  These quantifiable differences in spatial vision 
measured for the two conditions, indicate a difference in underlying neural bases for them 
(Hess and Bradley, 1980; Hess, Campbell and Zimmern, 1980; Levi and Klein, 1982; McKee, 
Levi and Movshon, 2003; Wong, 2012; Song, Levi and Pelli, 2014). More recently, evidence 
suggests that amblyopia not only affects visual processing at the primary visual cortex, but 
that the deficit due to amblyopia extends to, and becomes more exaggerated at, extra-striate 
cortex.   For example, measures of modulation sensitivity for contrast-modulated gratings and 
detection of second-order motion show greater losses than are found for first-order stimuli 
(such as standard contrast sensitivity gratings) in the amblyopic eye (Wong, Levi and McGraw, 
2001, 2005; Gao et al., 2015). 
 
Amblyopia is particularly sensitive to the phenomenon known as “visual crowding” in which 
letters presented together are not as easily individually recognised as those presented in 
isolation (Korte, 1923). Despite numerous extensive medical and scientific studies, the 
process by which crowding causes visual confusion and impaired recognition of targets like 
letters, is still not fully understood (Levi, 2008). Initially, visual crowding was thought to occur 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
3 
due to physiological and anatomical limitations of low-level cortical visual processing(Flom, 
Weymouth and Kahneman, 1963; Estes, Allmeyer and Reder, 1976; Ts’o and Gilbert, 1988; 
Gilbert et al., 1989), however more recent studies have demonstrated that higher cognitive 
factors such as figural and global aspects of visual processing, are strong contributors 
(Manassi, Sayim and Herzog, 2012; Herzog and Manassi, 2015).  
 
Crowding is clearly demonstrated in peripheral vision in normal healthy individuals; middle 
letters of a word are harder to distinguish than letters on either end.  However its presence 
has been confirmed in central vision of individuals with strabismic amblyopia, and to a lesser 
extent, those with anisometropic amblyopia (Stuart and Burian, 1962; Flom, Weymouth and 
Kahneman, 1963; Levi and Klein, 1985; Hess, Dakin and Kapoor, 2000; Kemper and Patel, 
2011; Spiegel et al., 2013; Lev, Yehezkel and Polat, 2014)(Flom, Weymouth and Kahneman, 
1963; Levi and Klein, 1985; Spiegel et al., 2013; Hess, Dakin and Kapoor, 2000; Kemper and 
Patel, 2011; Stuart and Burian, 1962; Lev, Yehezkel and Polat, 2014).  This means that 
crowding can be incorporated into vision charts in a clinical setting, as its presence will 
enhance visual acuity loss in the central vision of amblyopic eyes, but not in normal eyes.  
Traditionally, high contrast visual acuity charts have been used to examine visual acuity limits. 
In amblyopia however, central vision can be much more restricted by crowding from visual 
clutter, than by visual acuity itself (Song, Levi and Pelli, 2014).   Although currently available 
clinical vision charts attempt to incorporate crowding features, they are not successful at 
doing so in normal adults and some anomalous patients, and it is thought that they could be 
substantially improved (Hairol, Formankiewicz and Waugh, 2013; Formankiewicz and Waugh, 
2013; Song, Levi and Pelli, 2014; Pelli et al., 2016).  The proposed study will test whether 

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IRAS Number: 238449 
 
 
4 
recent suggestions for theoretical improvements in vision tests will actually result in more 
favourable outcomes with respect to diagnosing amblyopia, in the target developing 
population, i.e., young children. 
 
 

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IRAS Number: 238449 
 
 
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Rationale 
 
In the UK, a national vision screening is employed to detect amblyopia and other undiagnosed 
visual conditions in school-aged children, so that they can be managed effectively.  Better 
detection of amblyopia could be achieved by modifying current visual acuity tests, which 
measure the spatial resolution limit (or capacity for clarity and sharpness) of vision (Chung, Li 
and Levi, 2007; Formankiewicz and Waugh, 2013; Hairol, Formankiewicz and Waugh, 2013; 
Song, Levi and Pelli, 2014) and by measuring crowding distance; previously unmeasured in a 
clinical setting. By strengthening crowding magnitude, and better quantifying its spatial 
distance in paediatric populations, it is hoped that the ability to detect amblyopia, and 
monitor its improvement with treatment will be significantly enhanced.  
 
Three recent suggestions regarding modifications to current visual acuity tests may lead to 
improved detection of crowding-sensitive conditions, such as amblyopia. First, closer 
placement of surrounding letters to the target letter should increase the magnitude of 
crowding in the amblyopic eye in particular, leading to increased visual acuity differences 
between eyes (Formankiewicz and Waugh, 2013; Lalor, Formankiewicz and Waugh, 2016). 
Second, contrast modulated stimuli should enhance crowding in amblyopic eyes (Chung, Li 
and Levi, 2007, 2008; Hairol, Formankiewicz and Waugh, 2013).  Third, a new thinner font will 
allow clinical measures of foveal crowding distance (Pelli, Waugh, Martelli et al., 2016). In this 
project, these three modifications will be tested for the first time in the target clinical 
population.  

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IRAS Number: 238449 
 
 
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Formankiewicz and Waugh (2013) and Song, Levi & Pelli (2014) reported that optotypes 
(letters or symbols) on a vision chart should be placed closer together than they currently are 
on commercially-available charts, which use 2.5 to 5 stroke-widths separation between target 
and neighbouring letters.  Closer placement disrupts target optotype identification in normal 
peripheral vision (Formankiewicz and Waugh, 2013) and in central vision of amblyopic eyes 
due to crowding (Song, Levi and Pelli, 2014).  In one vision test in the proposed study, a 
laterally-reversible target letter (e.g., H, O, T or V) will be surrounded by four other letters (U, 
A, L, C). This arrangement, in which letters were separated by 0.5 optotype widths (or 2.5 
stroke widths) was first formally used in the Cambridge Crowding Test (Atkinson et al, 1988).  
In the proposed experiments, the surrounding letters will be placed 1 stroke-width away from 
the target letter (see Figure 1), the optimal position recommended by recent studies 
(Formankiewicz and Waugh, 2013; Song, Levi and Pelli, 2014).   
 
 
Figure 1: Modified Cambridge Crowding Test optotype arrangement 
 
Visual acuities for target letters will be measured for both amblyopic and non-amblyopic eyes 
of child participants, in a clinical environment.  These results will be compared with visual 

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acuities acquired during the clinical appointment using the Sonksen logMAR Test (SLT), which 
is the standard visual acuity test used in Cambridge University Hospital, Addenbrooke’s 
Orthoptic Department (see Figure 2).   
 
 
Figure 2: The Sonksen logMAR Test (SLT) 
 
In the Sonksen logMAR Test (SLT), a single line of 4 letters separated from each other by 5 
stroke-widths (or 1 optotype width), is contained within a box, separated from the letters also 
by 5 stroke-widths. 
 
Recognition of target optotypes created by contrast-differences (second-order stimuli) is 
prone to greater crowding effects than is recognition of optotypes created by luminance-
differences (first-order stimuli) (Wong, Levi and McGraw, 2001, 2005; Chung, Li and Levi, 
2008; Hairol, Formankiewicz and Waugh, 2013).  This effect is present in normal vision, 
however even greater visual losses for contrast-defined targets, as well as stronger crowding 
effects, have been reported in amblyopia (Chung, Li and Levi, 2008).  By presenting a contrast-
modulated (CM) target letter (H, O, T or V) surrounded by four other letters (U, A, L, C) placed 
1 stroke-width away (in the modified Cambridge Crowding Test arrangement), this research 
aims to examine whether this second-order vision test will exaggerate differences between 
the eyes of amblyopic children, when compared to those measured in visually ‘normal’ 

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children. The results will again be compared to those obtained with the Sonksen logMAR test 
(SLT), a first-order vision test, to compare their sensitivities to amblyopia detection.   
 
Finally, crowding distance, the spatial distance over which crowding occurs, in normal foveal 
(central) vision is small (2-4 arcmin) and cannot be measured with current standard clinical 
optotypes due to their large size (5 arcmin for 0.0 logMAR acuity) (Danilova and Bondarko, 
2007; Huurneman et al., 2012; Siderov, Waugh and Bedell, 2013; Pelli et al., 2016).  To get 
around this difficulty,  a new vision test was recently created to quantify the crowding 
distance or “critical spacing” of crowding (Pelli, Waugh, Martelli et al., 2016).  It uses a new 
“Pelli” font (see Figure 3), which is much thinner horizontally than standard clinical fonts, 
allowing the optotypes to get closer to each other in physical space.  This ‘Crowding Distance 
Test’ permits quantification of the critical spacing of crowding for the first time in a clinical 
population.  The new “Pelli” font, each optotype appearing like tall skinny numbers, has 
already been trialled on ‘visually normal’ school-aged children (Waugh et al., 2018), but not 
yet examined on children with greater sensitivity to visual crowding, i.e.,  amblyopes.  The 
third vision test in the proposed research, will investigate whether or not “crowding distance” 
measures made in each eye, results in greater inter-ocular differences, leading to better 
detection of anisometropic and strabismic amblyopia than does the current clinical standard 
visual acuity test, the Sonksen logMAR test (SLT).  

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Figure 3: ‘Pelli’ font 
 
By using closer first-order target optotypes, second-order target optotypes, and quantifying 
crowding distance in paediatric populations, the ability to detect amblyopia and monitor 
amblyopia treatment, could be significantly improved for the first time since the 1960s.  At 
that time crowding was first quantified in a clinical population of adult amblyopes (Flom, 
Weymouth and Kahneman, 1963) and was subsequently incorporated into commercially 
available tests as best practice.  

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Research questions and aims 
 
Research question: 
“Do the new vision test modifications offer better sensitivity to detection of inter-ocular 
difference leading to improved detection and monitoring of amblyopia, than the Sonksen 
logMAR test (SLT)? 
 
Secondary research question: 
“Is there a difference in sensitivities of these modifications to detecting strabismic amblyopia 
versus anisometropic amblyopia?” 
 
Hypotheses 
Null hypothesis 1 (H1O): The new crowding tests do not offer better sensitivity to inter-ocular 
differences in acuity in amblyopic children, than the Sonksen logMAR test (SLT).  
Alternative hypothesis 1 (H1a): The new crowding tests do offer better sensitivity to inter-
ocular differences in acuity in amblyopic children, than the Sonksen logMAR test (SLT).  
Null hypothesis 2 (H2O): There is no difference in the sensitivities of the new tests to detecting 
strabismic amblyopia, versus anisometropic amblyopia. 
Alternative hypothesis 2 (H2a): There is a difference in the sensitivities of the new tests to 
detecting strabismic amblyopia, versus anisometropic amblyopia. 
 

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The following steps will be taken in order to complete this project: 
1. Critically appraise relevant literature about the effects of crowding on visual acuity in 
normal and amblyopic adults and children for first-order and second-order optotypes.    
2. Design a study to incorporate three suggested modifications to current visual acuity 
and crowding tests, in a sample of child control and amblyopic participants. 
3. Statistically analyse the results, comparing those obtained on control and amblyopic 
children, as well as with data already gathered from normal healthy children. Data 
from the new tests will be compared with each other and with those obtained using 
the standard clinical vision test (the Sonksen logMAR Test: SLT).  
4. Accept or reject the given null hypotheses and discuss impact on clinical practice in a 
written thesis, as well as disseminate results at scientific conferences and in scientific 
peer-reviewed journals. 
 
 
 

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IRAS Number: 238449 
 
 
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Study design, methods of data collection and data analysis 
Study design 
In this single centre study results from the ‘Enhanced Cambridge Crowding Test’, ‘Contrast-
modulated Cambridge Crowding Test’ and the ‘Crowding Distance Test’ in their ability to 
detect amblyopia will be assessed using a prospective quantitative randomised controlled 
design. The results obtained from the experimental groups (anisometropic and strabismic 
amblyopia) will be compared to Sonksen logMAR test (SLT) results (assessed and documented 
by the ACPOS clinicians).  They will also be compared to those obtained in this study from a 
control group.  The testing will take place in a clinical room neighbouring the ACPOS 
(Addenbrooke’s Community Paediatric Ophthalmology Service) clinic, which is hosted within 
the University Eye Clinic at Anglia Ruskin University (ARU). 
 
Study procedure 
Prospective participants will be identified by their clinician at their ACPOS clinical 
appointment, and given participant information leaflets. Healthy volunteers will also be 
accepted as control participants and given participant information leaflets. All participants 
will be required to provide informed assent, and their parent/guardian provide written 
informed consent before the experiments are conducted and after the nature and 
consequences of the study are explained. COVID tracking consent forms  The recruitment and 
consent process will be monitored by the Principal investigator within the University Eye Clinic 
at ARU.  
 

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All tests will be conducted with the child’s corrective lenses if required, after consent and 
assent is achieved. The child’s Ophthalmology clinical team will be informed of their 
participation by use of an addendum into the clinical notes, if recruited through the ACPOS 
clinic. To reduce the risk of potential exposure to COVID-19 by participants during testing, the 
researcher will wear an apron and a mask. The researcher, participant and parent will wash 
their hands upon entering the testing room (which has its own sink and sanitising soap) and 
wear masks (Medical F2 as per ACPOS clinical protocol). Children under 11 may choose to not 
wear a mask. Individual risk assessments are conducted at the time of appointment creation 
by ACPOS/Addenbrooke’s staff. All high-risk participants and parents will NOT have 
appointments entered into the recruitment system.  All participants are children, so risk is 
minimal. All equipment will be Clinell wiped before and after use. Disposable occlusive 
patches and social distancing will also be used throughout testing. 
 
The testing session is expected to take 45 to 60 minutes, depending upon the attention span 
and cooperation of the child; this includes regular breaks and relaxation points. It will not be 
possible to blind the researcher as to which group test participants have been allocated, as 
those patients with strabismic amblyopia will likely be easily identified due to the presence of 
their strabismus. 
 
Background information will be recorded on data collection sheets (Appendix 1), and results 
of the vision tests are recorded as data files on the experimental/display computer.  
Participants need only complete one testing session, but may complete to 3 sessions over the 

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24 month period.  Additional sessions would allow for analysis change over time. Participants 
are free to decide on the length of their participation and can leave the study at any time. 
 
Background information 
Prior to testing, the following relevant clinical information will be taken from the patient’s 
digital medical records, or measured and recorded by the PI who is a registered Orthoptist;  
1. Age  
2. Gender 
3. Diagnosis and Amblyopia subtype 
4. Identification of fellow and amblyopic eye 
5. Most recent SLT visual acuity result for each eye, for healthy volunteers this will be 
assessed by the PI. 
6. Current refractive correction 
7. Stereoacuity measurement. For healthy volunteers this will be assessed by the PI to 
ensure inclusion criteria are met. 
 
This information will be used to identify which group the participant will be recruited to 
(anisometropic, strabismic or control) and also to aid randomisation of initial testing eye 
within each group. The participant will also be allocated a participant number and all results 
will be recorded using this participant number to preserve anonymity. 
 
 

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IRAS Number: 238449 
 
 
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Randomisation 
Each group will undergo covariate adaptive randomisation using minimisation to select which 
eye will be examined first (Hu et al., 2014). Test participants will have either their Amblyopic 
eye (AE) or Fellow eye (FE) assessed first for all 3 experiments, and control participants will 
have either their Right eye (RE) or Left eye (LE) assessed first. This will ensure equal 
distribution of known confounding variables (e.g. amblyopia density, occlusion regime, 
gender) for testing order bias between eyes.  This minimisation process will allow for better 
statistical analysis and extrapolation of results. The order of experiments will be 
counterbalanced to prevent testing order bias.  
 
It will not be possible to guarantee equal distribution within groups across age, as it is 
expected that most recruited participants will be around 5 years of age because the National 
Vision Screening programme occurs during the first year of school.  
 
Materials  
The presentation and control of visual stimuli will use custom-written Matlab programmes 
(MathWorks™, Natick, USA), using the ‘Psychophysics Toolbox Version 3 (PTB-3)’ on a 
15”MacBook Pro with Retina Display, operating an Intel HD 630 Graphics card. The monitor 
will be calibrated and gamma corrected using an OptiCal photometer (Cambridge Research 
Systems). This will secure a linear progression of luminances, ensuring the input selected 
matches the luminance output produced, allowing for correct interpretation of the results. 
The screen resolution will be set to the highest possible spatial resolution (1920x1200 pixels) 

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and the frame rate will be set to the highest frame rate compatible with the aforementioned 
spatial resolution.  
 
Optotypes for the ‘Enhanced Cambridge Crowding Test’, ‘Contrast-modulated Cambridge 
Crowding Test’ and the ‘Crowding Distance Test’ will each be printed onto respective 
matching cards, allowing for participants to point to what they see, if they are unable or 
unwilling to name the displayed visual stimuli.  
 
Methodology  
All participants will have the tests explained to them in the form of an astronaut story and 
they will complete tasks (the 3 modified vision tests) in order to help the astronaut complete 
his/her missions successfully.  This will ensure that the examination is fun and engaging, with 
the aim of improving compliance and concentration. The eye not being tested will be occluded 
with an eye patch, or a patch that clings to a spectacle lens. All assessments will be completed 
at 3m, as this will allow the researcher to sit near the child so they can encourage compliance. 
Amblyopic eyes may be moved closer to the screen to accommodate for their poorer vision, 
and their threshold scores recalculated accordingly. 
 
Staircase procedures will be used to measure vision (Lalor, 2018; Pelli, Waugh, Martelli et al, 
2016; Waugh et al., 2018).  The staircase is a quick, efficient and popular method of 
determining an accurate visual acuity threshold; it is therefore an appropriate method of 
evaluating visual acuity thresholds with young children in clinical settings (Cornsweet, 1962; 
Corwin, Kintz and Beaty, 1979; Witton, Talcott and Henning, 2017).  

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
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Participants will be required to identify the central target optotype presented onto the 
screen, from different surrounding optotypes. No feedback will be given about the accuracy 
of their response. In each trial, unlimited time is provided for responses to be made, however 
prompt answers will be encouraged.  Guesses are required when the target optotype is near 
to the participant’s visual resolution limit.  To mitigate anxiety for these trials, the staircase 
procedures also include intermittent “catch” trials, which are single large optotypes much 
larger (0.3 logMAR) than the expected acuity threshold.  These catch trials do not contribute 
to threshold calculations.  Catch trials also reduce the predictability of the test, another 
advantage when testing children (Bach, 1996).  
 
A staircase procedure ends once visual threshold is reached.  This involves averaging a 
number of reversals (normally 6), however the first 2 reversals are disregarded to prevent 
overestimation of the visual acuity threshold (Witton, Talcott and Henning, 2017).  The total 
number of averaged reversals can be reduced from 4 to 2 if necessary with only a slight loss 
of accuracy, depending upon the child’s age, concentration and attention span. 
 
Computer generation of visual stimuli 
In order to produce computer-generated visual acuity optotypes, every size of the two types 
of optotype (letters and ‘Pelli’ numbers) have been carefully checked and calibrated to ensure 
accurate physical size.  Optotypes are constructed using Matlab (MathWorksTM, Natick, USA) 
matrices and scaled to allow for a large range of stimulus sizes to fit on the screen.  
 

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Psychophysics toolbox software (Pelli, 1997) is combined with Matlab for the generation and 
experimental display of sequences of stimuli.  Optotype sizes produced and participant 
viewing distance (3m) is used to calculate an accurate size or logMAR acuity score (log of the 
minimum angle of resolution in minutes of arc). The custom-written program guarantees that 
all stimuli in this study are constructed in multiples of whole numbers of pixels, so that exact 
logMAR scores are calculated (not estimated).  The lower limit of optotype size is restricted 
by a minimum number of pixels required to adequately form each optotype.  
 
Contrast-modulated optotypes for the ‘Contrast-modulated Cambridge Crowding Test’ are 
created using dynamic noise (Smith and Ledgeway, 1997) to ensure that static luminance 
clumps are not useful for identifying them.  Optotypes can then only be extracted by the visual 
system using differences in contrast, not luminance (see Figure 5).  For each stimulus frame, 
different binary (black or white) checks of noise are drawn onto the screen and the noise is 
multiplied by a square-wave optotype profile.  The screen cycles through several noise pages 
every 4 temporal frames (tied to the temporal resolution limit of the screen), so that the noise 
appears to twinkle in time.  The size of the black and white noise checks on the stimulus screen 
is scaled to the overall optotype size, such that each letter consists of 15 noise checks, which 
has been found to be most effective for measurement of vision (Pelli and Farell, 1999) and 
ensures that the noise is resolvable at all optotype sizes. 
 
Experiment 1 –Enhanced Cambridge Crowding Test 
The participant will be shown the Cambridge Crowding Test letter matching card prior to the 
start of the experiment, and asked to name the letters, with whatever names they wish to 

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use. If they cannot do this with ease, they will be allowed to match what they see, by pointing 
to an optotype on the matching card (see Figure 4). 
 
 
 
Figure 4: “Enhanced Cambridge Crowding test” matching card 
 
A laterally-reversible target letter (e.g., H, O, T or V) will be displayed and surrounded by 
four other letters (U, A, L, C) as per the Cambridge Crowding Test (Atkinson et al., 1988). The 
surrounding letters will be placed 1 stroke-width away from the target letter (see Figure 1).  
Isolated letters will also be presented.  The child will identify the central letter only. Once 
threshold is reached the experiment will stop. After a short break, the second eye is tested 
in the same manner. It is expected that this should take approximately 5 minutes based on 
pilot experiments. This is the end of experiment 1. 
 
 

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IRAS Number: 238449 
 
 
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Experiment 2 – Contrast-modulated Cambridge Crowding Test 
The participant will again be allowed to match (see Figure 5) or name the visually displayed 
optotypes. 
 
 
Figure 5: “Contrast Modulated Cambridge Crowding Test” matching card 
 
A contrast modulated letter will be displayed on the computer screen in an arrangement as 
per Experiment 1, with the surrounding letters placed 1 stroke-width away from the target 
letter. The participant will identify the central letter, the size of which will vary according to 
the staircase procedure until size threshold is reached; then the experiment will stop. 
Examination of both eyes will take approximately 5 minutes, including a comfort break, based 
on pilot experiments.  
 

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IRAS Number: 238449 
 
 
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Experiment 3 – “Crowding Distance Test” 
The participant will be shown the “Crowding Distance Test” matching card prior to the start 
of the experiment, and ask to name the numbers.  They will be able to indicate what they see 
by either calling out the number or pointing to it on the matching card (see Figure 6). 
 
 
Figure 6: “Crowding Distance Test” matching card 
 
A trigram arrangement (a trio of numbers) with 1 stroke width separation, will be presented 
according to an adaptive staircase procedure. The child will identify the central number and 
visual threshold will be established using a staircase procedure.  The second eye will be 
examined in the same manner taking approximately 5 minutes, based on pilot experiments. 
 
Following a short break, repeated numbers (two repeating numbers that fill the screen) 
separated by 1 stroke width separation, will be presented.  The repeated arrangement is 
helpful when eye movements are unstable, as it allows the eye to find the target optotype 
regardless of where on the screen it lands.  This procedure will be repeated with the other 

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eye.  The anticipated time to complete the measure in both eyes is around 5 minutes. This is 
the end of Experiment 3, and the end of the testing session. 
 
The order of tests or experiments will not always be the same, but will be counterbalanced 
across participants within any experimental group to ensure that thresholds are not biased 
due to practice, attention, or fatigue effects. 
 
Throughout the study, participants will be offered stickers and stamps on a ‘passport’ to 
maintain interest and concentration, as well as making the study fun and engaging.  The tests 
follow a story line about a teddy astronaut visiting outer space, and alien toys helping the 
participants to interpret the signs (optotypes) along the way.  Soft toy teddies and aliens will 
decorate the room and be available to help the child if need be.  This has been found to be 
helpful particularly with young children (Waugh et al, 2018). 
Following completion of the vision tests, participants will be asked if they wish to be involved 
again with the study. If they do, then they will be tested again following their next Orthoptic 
review with the ACPOS clinic, or at a time that suits the family best. If they do not, this is the 
end of their participation. 
 
Consideration of measurement tools, validity and reliability 
The results will be generalizable to the entire UK screening population of 3 to 11-year-olds, 
due to the use of a control group, ensuring external validity. 

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24 
 
Participant bias will be controlled and intra-observer reliability maximised using the rigorous 
set of forced-choice psychophysical testing procedures described above and a single 
specialized researcher. The researcher is a qualified clinical Orthoptist with many year’s 
experience working with children in vision screening clinics, ensuring that the results will be 
obtained as accurately and consistently as possible.  Test/re-test reliability is ensured by the 
use of randomization of the order in which the eyes are examined, and counterbalancing the 
order of the experiments.  
 
Statistical consideration and Data management and analysis  
Anonymised data from the 3 experiments will be stored digitally on the experimental 
computer, which is password protected and only accessible to members of the research team.  
Data will be compiled in an Excel spreadsheet, ready for analysis. 
 
The data will be analysed using SPSS or Statistica with Repeated Measures Analysis of 
Variance models. Visual acuities, crowding and critical spacing estimates will be compared 
between normal and amblyopic groups.   Confirmation of normality and sphericity will be 
assessed with a Shapiro-Wilk test and Mauchley’s Test of Sphericity and where necessary, 
error rates will be adjusted with a Huynd-Feldt Correction in order to ensure that type 1 errors 
(incorrect rejection of the null hypothesis) are less likely.  
 

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The rate of improvement of visual acuity, crowding and critical spacing over the treatment 
period will also be compared (in those participants who opt to complete more than one 
assessment session) between the three modified tests, and the SLT.  
 
A Bland-Altmann analysis will also be used to assess levels of agreement between the 
different test measures, rather than examination of correlation alone. This is because while a 
high correlation may be an interesting finding, it does not necessarily indicate agreement 
between the different test measures (Martin Bland and Altman, 1986).  
 
 
 

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IRAS Number: 238449 
 
 
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Study Setting 
The study will take place in a first floor clinical room with daylight fluorescent lighting, within 
the University Eye Clinic on Bradmore Street, Cambridge; and will take place Monday to 
Friday, 9am to 5pm. 
Clinic Address: 
University Eye Clinic, 
Bradmore Street, 
Cambridge, 
CB1 1PT 
Telephone: 
01223 698070 
Site 
Activities 
ACPOS clinic  - based at the University Eye 
Clinic 
Patient Identification point 
Potential participants approached and 
given study information leaflets by ACPOS 
clinician. 
Experimental/clinical room – based at the 
University Eye Clinic 
Recruitment, consent, recording of 
background information, completion of 
visual acuity testing. 
 
 
The study room is a modified clinical room.  It contains appropriate seating for a participant 
to be tested as well as sufficient and comfortable space for the presence of the researcher 
and the participant’s parent/guardian. Bathrooms are located on the same corridor, and 
access to the first floor is available via stairs or a lift. Telephones are present within the testing 

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room and additional staff are present in the building at all times the clinic is open, ensuring 
that help can be obtained at all times should an unexpected emergency arise.  University first-
aid is available directly using the phone in the testing room.  The clinical suitability of these 
rooms for the purposes of visual acuity assessment has been evaluated by Anglia Ruskin 
University and an appropriate risk assessment has been completed. 
 
 

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Sample and Recruitment 
Study population and sampling technique: 
This study will prospectively examine children who fail vision screenings at school and those 
already being treated. Amblyopic and control participants (aged 3 to 11 years) will be 
identified via ACPOS (Addenbrooke’s Community Paediatric Ophthalmology Service) hosted 
by the University Eye Clinic.  The ACPOS clinic will be a Patient Identification Centre (PIC), and 
an information poster will be present in the ACPOS waiting room to alert patients that they 
may be asked if they would like to participate (Appendix 1). 
 
Potential participants will have been identified by ACPOS clinicians as having anisometropic 
or strabismic amblyopia. Control participants of similar age will also be recruited via the 
ACPOS clinic as false positive referrals from the screening service. Healthy volunteers will also 
be acceptable as control participants. The pool of amblyopes projected for 18 months is 
n=278; 60% strabismic, n=167 (based on a 2016-2017 Addenbrookes audit).   
 
As the participants will mostly have undertaken the normal screening programme and be 
following treatment plans as guided by the Royal College of Ophthalmology, these results 
should be able to be generalised to all UK 3 to 11-year-olds diagnosed with amblyopia. 
 
 
 

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Eligibility Criteria – Inclusion criteria: 
• Test participants; Male and female 3 to 11-year-old children diagnosed by ACPOS 
clinicians as likely having amblyopia (strabismic or anisometropic).  They will be tested 
following 6 weeks (or more) of refractive adaption. 
 
• Control Participants; Male and female 3 to 11-year-old children who have been falsely 
referred into the Hospital Eye Service (ACPOS) by the visual screening service, or 
healthy volunteers who have satisfactory visual functions, as per the national 
screening guidelines.  
 
• All participants must be able to complete the Sonsken logMAR Test (SLT) either 
verbally or via use of a matching card. 
 
Eligibility Criteria – Exclusion criteria: 
• Uncorrected refractive error. 
• The presence of any other vision limiting medical condition, not listed in the inclusion 
criteria. 
• Any prior or existing medical history of epilepsy or seizures. 
 
 

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Sample Size: 
Based on data produced from previous studies, the outcome data obtained from this study 
will come from an underlying continuous and normal distribution.   
 
As the first alternative hypothesis is two-tailed, a t-test is appropriate for the calculation of 
sample size, to find an estimated effect size, with standard deviations known for the visual 
acuity measures (Hulley and Cummings, 1988). A comparison of means during statistical 
analysis (Repeated Measures ANOVA) makes this a suitable strategy for determining sample 
size. 
 
The effect size is set at 0.100 logMAR, which is the minimum inter-ocular difference that 
should exist for the participant to be classified as amblyopic (Elliott and Firth, 2009). The 
standard deviation of the visual acuity measure is set as ±0.100 logMAR.  In adults, visual 
acuity repeatability measures of ±0.1 logMAR have been found (Klein et al, 1983; Arditii & 
Cagenello, 1993; Siderov & Tiu, 1999).  Lalor (2018), who used staircase procedures like those 
proposed, found for children aged 3 to 16 years, standard deviations of ±0.06 logMAR.  Pilot 
studies with the Crowding Distance Test have suggested even lower standard deviations  of 
the test measures (Waugh et al., 2018). 
 
Using a standardarised effect size of 1 (effect size/sd of measure; or Cohen’s d of 1), a 
significance level or probability of committing a type 1 error (incorrect rejection of null 
hypothesis), of 0.05; and the probability of committing a type 2 error (incorrect acceptance 
of null hypothesis) of 0.2 (power of 0.8), a sample size of n=16 participants in each group 

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(amblyopes and control participants) will be required to achieve statistical significance, if a 
difference exists.  
 
In brief, the data generated will be analysed using a Repeated Measures Analysis of Variance 
(with Huyndh-Feldt correction for violation of sphericity of variance).  In this procedure means 
are compared.  Also post-hoc Tukey comparisons between groups can be made; or a Dunnett 
test comparing each group (anisometropic; strabismic) to the control group (normal controls)  
 
The above calculation is sufficient for a comparison of means.  The second hypothesis involves 
three distinct groups with independence of observation.  An alternative way to estimate sample 
size is to conduct a one-way ANOVA using an effect size Cohen’s f, is set at 0.4 (for “large” effect 
size) to examine for large effect sizes. Once again, the significance level or probability of 
committing a type 1 error is set at 0.05, and the probability of committing a type 2 error is set at 
0.2, to yield a study power of 80%.  
 
Following this power calculation, a sample size of n=21 participants in each group 
(anisometropic amblyopes, strabismic amblyopes and control participants) will be required 
to achieve statistical significance, if a difference exists.  
 
These figures produce an estimated total sample size of n=32 for testing Hypothesis 1 (16 
amblyopes and 16 controls), and n=63 for testing Hypothesis 2 (21 anisometropic amblyopes, 
21 strabismic amblyopes and 21 controls).  
 

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In order to fulfil both these criteria for hypotheses 1 and 2, and achieve statistical significance, 
we will recruit n=21 in each group (anisometropic amblyopes, strabismic amblyopes and 
control participants), with a total recruitment number n=63. 
 
Recruitment and identification of participants: 
The study will be publicised in a number of ways. 
1. A poster will be displayed in the waiting room of the ACPOS clinic in order to raise 
awareness of the study to those who attend the clinic (Appendix 1). 
2. Clinicians / the direct care team at ACPOS, will identify eligible participants during their 
clinical appointments, and offer them a study information leaflet. ACPOS will be the 
Patient Identification Point (PIC). An application will be made for the Principal 
Investigator to have a research passport (letter of access/ honorary research contract) 
in order to help identify potentially suitable participants attending the ACPOS clinic. 
The Principal Investigator is suitable for this task as she worked as the clinician in this 
clinic prior to starting this study. 
 
Interested persons will be given the parent / guardian and paediatric information sheets 
(Appendix 1) and their medical history checked to ensure they meet all the inclusion criteria 
and none of the exclusion criteria, prior to recruitment.  For ACPOS individuals who do not 
wish to take part, the clinician will add an addendum to the participant’s clinical notes to 
ensure that the participant is not approached again as a potential participant. 

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The clinician will notify the researcher if the participant wishes to take part, or the participant 
can contact the researcher directly using the details on the information leaflet. The researcher 
will then discuss the research with the prospective participant and their parent/guardian, 
giving opportunity for further questions to be asked and answered. If the participant and their 
parent/guardian demonstrate understanding of the requirements of the study and wish to 
consent to take part, the parent/guardian will be given a consent form to sign, and a record 
of clear assent will be taken from the participant (Appendix 1). Both parental consent and 
clear participant assent must be obtained in order for the participant to be recruited.  Once 
consent and assent are provided, the researcher will add an addendum to the participant’s 
clinical notes to inform clinicians. This will again ensure that the participant is not repeatedly 
approached as a potential participant.  
 
While participants will not be paid for their participation in the study, they will be offered a 
£10 Amazon gift voucher as compensation for their time as a result of participating in the 
study. 
 
 

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Ethical considerations 
This research will be conducted in full conformation with the principles of the “Declaration of 
Helsinki”, Good Clinical Practice (GCP) and within the laws and regulations of the United 
Kingdom; and on approval by Anglia Ruskin University and the local NHS research ethics 
committee (REC). Prior to recruitment, participants will be given full written information 
about the study, in order to allow them to make an informed decision as to whether or not 
they wish to participate. Participation will require both signed informed consent from a legal 
guardian and informed assent from the child following the provision of age appropriate 
written information.  Participants can also withdraw from the study at any point without any 
given reason, without prejudice.  
 
The sensitivity of the new tests, compared with the existing SLT test, will not be known until 
data analysis is complete. If the data suggest that the new tests provide additional useful 
clinical insight into the participant’s visual condition, this information will be shared with the 
Ophthalmology clinical team to ensure the participants continue to receive appropriate 
management. 
 
The supervisory team already hold ethics approval to conduct similar testing on children who 
attend the University Eye Clinic outside the hospital system, and the researcher is a trained 
Orthoptist with many years of clinical hospital experience, testing vision in children and 
adults. 
 

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Assessment and management of potential risks: 
Possible potential for Physical harm: Eye strain and fatigue. Screen refresh rates and flicker 
present in contrast-modulated optotypes may be a trigger for individuals with a history of 
seizures or Epilepsy, therefore individuals with these conditions are excluded from this 
research. 
 
Potential for distress: Subjects may become slightly anxious or bored, if they struggle to 
visually identify images when asked. Mediation of anxiety and boredom can be managed 
providing support and encouragement throughout testing, by delivering the testing in the 
form of a game thereby making testing fun, and ensuring that the subject knows they can 
withdraw from the testing at any time. Boredom will also be reduced by use of Catch trials, in 
order to ensure that the child has not become disengaged with testing. 
 
Participants and parents/guardians will be informed of these risks prior to recruitment in 
written form. Children will also be given age appropriate written information explaining what 
they will be doing. This will also be explained again verbally, prior to consent forms being 
signed. 
 
 
 

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Patient safety 
The following precautions have been taken for this study, 
• Any child with a prior or existing medical history of epilepsy or seizures will be 
excluded from the study, due to an associated risk of screen flicker. 
• Each examination will take place in a well-lit testing room at Anglia Ruskin University, 
with the child’s parent / guardian present at all times during the experiment. 
• Regular breaks will be given throughout testing in order to prevent fatigue and 
boredom. 
• Participants are free to withdraw from the study at any point without any given reason 
and without prejudice. 
• If the participant reveals information which raises safeguarding issues, then these 
concerns will be raised with the child’s clinician, who will be able to check if the child 
already has protection plans in place and ensure that the hospital or community 
safeguarding team can examine the situation in more detail. 
 
There are minimal risks to the child participants. These are similar to those experienced during 
normal clinical appointments. Frequent breaks between tests are always possible and they 
are made to be fun and engaging. Sometimes the child will need to guess, but support and 
encouragement will be provided throughout. 
 
 
 

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Research Ethics Committee (REC) and other reviews 
Peer Review 
This study proposal has been examined by the Research Supervisory Team prior to submission 
to the FRDSC (Faculty Research Degree Subcommittee) for peer review. 
 
This proposed study has been approved by three reviewers, two with subject-specific 
expertise, from outside the Research Supervisory Team, but within the Faculty of Science and 
Technology, Anglia Ruskin University.  The report by reviewers recommended (on 21/2/18) 
that the research proposal is approved by FRDSC, as being suitable for PhD level study.  
Approval will be ratified at the FRDSC meeting 3/5/18.  
 
Research Ethics Subcommittee (RESC) 
This Subcommittee of the Research Committee considers policies and procedures relating to 
the ethics of research investigations involving human participants, human tissue and organs, 
animals and other research that presents ethical issues undertaken by staff and students of 
Anglia Ruskin University. Responsibility for the approval of individual research ethics 
applications is devolved by Research Ethics Subcommittee to Faculty Research Ethics Panels. 
Before the start of the study, a favourable opinion will be sought from the HRA and a REC for 
the study protocol, informed consent forms and other relevant documents. 
 

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Substantial amendments that require review by NHS REC will not be implemented until that 
review is in place and other mechanisms are in place to implement at site and all 
correspondence with the REC will be retained. 
 
It is the Chief Investigator’s responsibility to produce the annual reports as required and the 
Chief Investigator will notify the REC of the end of the study. An annual progress report (APR) 
will be submitted 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. 
 
If the study is ended prematurely, the Chief Investigator will notify the REC, including the 
reasons for the premature termination. Within one year after the end of the study, the Chief 
Investigator will submit a final report with the results, including any publications/abstracts, 
to the REC. 
 
The Chief Investigator will ensure that appropriate approvals and research passports/letters 
of access from participating organisations are in place before any research takes place.  
 
Amendments 
For any amendment to the study, the Chief Investigator, in agreement with the sponsor will 
submit information to the REC in order for them to issue approval for the amendment. The 
Chief Investigator will work with sites (Addenbrookes R&D, the ACPOS clinic and ARU) so they 

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39 
can put the necessary arrangements in place to implement the amendment to confirm their 
support for the study as the amendments state. 
 
Patient & Public Involvement  
ARU encourages students and supervisors to identify and exploit opportunities for wider 
promotion of their research activities including media activities, public engagement, or 
knowledge transfer activities where this might be desirable or appropriate and to 
demonstrate excellence and impact. 
 
A previous study has been conducted by the Research Supervisor to obtain data using the 
same new visual acuity tests to be used in the proposed study, on 200 normal healthy 
children.   A selection of these results have been accepted for presentation at Vision Sciences 
Society 2018, Florida, U.S.A.  (Waugh, S. J. et al. (2018) ‘Crowding distance in healthy children’, 
in Vision Sciences Society).  This initial study has allowed for previous public involvement to 
shape the design of the proposed research project.   
 
The involvement of the public / patients in the proposed study will be participation during the 
testing / experimental phase.  
 
Participants will be able to request access to the general conclusions of the study, and the 
results will be disseminated publically at research conferences and in scientific journals. 

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Protocol compliance 
The Chief Investigator will be expected to conduct the study in compliance with the approved 
protocol agreed upon by the Sponsor and REC approval. All protocol deviations should be 
identified, documented and reviewed for impact on subject safety and data integrity by the 
Chief Investigator. The Chief Investigator should implement any required operational 
corrective action to address deviations and collaborate with the Sponsor/ research 
supervisory team to determine whether a deviation requires a protocol amendment. 
 
Data protection, storage and destruction policy: 
As per the university and UK Data service guidelines, data generated by and pertaining to this 
study will be appropriately destroyed at the following intervals; 
 
Pseudo-anonymised research data based 
on clinical samples for public health 
To be kept (in encrypted form) for between 
15 – 20 years and then destroyed. 
Consent forms 
To be securely kept at the University with 
the research data as per the UK Data 
service guidelines. 
 
Hard copies of personal data (consent forms and anonymised data sheets) will be stored 
throughout the duration of the study in a locked filing cabinet within the Department of Vision 
and Hearing Sciences, Anglia Ruskin University; in a secure room requiring passcode protected 
access.  Digital copies (all password protected) of the study information (pseudo-anonymised 

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with name removed), will be scanned and encrypted and stored on University password-
protected virtual space accessible only to members of the research team, after which physical 
copies will be confidentially shredded at the conclusion of the study.  Data will be shared 
publicly via University protected space known as ARRO (ARU Research Repository Online) 
https:\\arro.anglia.ac.uk.  The data will also become open-access if required during the 
publication process. This research is not externally funded, however the data will be stored 
for 20 years after publication on the University secure space, according to RCUK Concordat 
on Open Research Data. 
 
It will be the responsibility of the Principal investigator to ensure that the filing cabinet holding 
personal data during the term of the project is not accessed by any person outside members 
of the research team. She will also ensure that after the retention period, these paper-based 
data are confidentially shredded using University systems for doing so. 
 
Confidentiality 
 
In accordance with General Data Protection Regulation (GDPR), the following precautions will 
be taken; 
• The results will be obtained and processed for a specific purpose, with full-informed 
assent given by the subject and informed written consent by their guardian. 
• The information gathered will be relevant and not excessive for the purpose of the 
study. 

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• The information gathered will not be kept for longer than necessary. 
• The personal patient information will be kept in a locked secure filing cabinet, and all 
the results anonymised. 
• All digital information will be anonymised and password protected. The data cannot 
be overwritten and is backed-up to a secure, university owned, password protected 
wireless hard drive. 
 
Indemnity 
Indemnity will be provided by Anglia Ruskin University who have hold professional indemnity 
insurance with U.M Association Limited (Appendix 1). 
 
Professional Indemnity details 
 
 Limit of Indemnity  
£10,000,000 any one claim and in the 
aggregate except for Pollution where cover 
is limited to £1,000,000 in the aggregate.  
Cover provided by  
U.M. Association Limited and Excess Cover 
Providers led by CNA Insurance Company 
Limited  
 
 
 

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43 
 
Clinical Trials liability details 
Limit Of Indemnity  
£30,000,000 any one claim and in the 
aggregate, including claims costs and 
expenses.  
Cover provided by  
U.M. Association Limited and Excess 
Cover Providers led by QBE Insurance 
(Europe) Limited  
 
 
Public and products liability details 
 
 Limit Of Indemnity  
£50,000,000 any one event and in the 
aggregate in respect of Products Liability 
and unlimited in the aggregate in respect 
of Public Liability.  
Cover provided by  
U.M. Association Limited and Excess 
Cover Providers led by QBE Insurance 
(Europe) Limited  
 
 
 

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Employers’ liability details 
 
Limit of Indemnity  
£50,000,000 any one event unlimited 
in the aggregate.  
Includes  
Indemnity to Principals  
Cover provided by  
QBE Insurance (Europe) Limited and 
Excess Insurers.  
 
Access to full dataset 
Only the Chief investigator, Principal investigator and the allocated Research Supervisors will 
have access to the full dataset for this single centre study. It is not envisaged that the dataset 
will be used for secondary analysis. Site investigators will be granted access to the full dataset, 
only if a formal written request is made to the FRDSC, and approved. 
 
 

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Study Outcome Dissemination 
Exploitation and Intellectual Property Rights  
ARU asserts the right to ownership of all intellectual property (IP) rights arising from research 
it funds through a VC PhD Studentship.  A student should not enter into any agreement that 
may affect rights to exploit the IP arising from their work without first consulting the Director 
of RIDO (Research and Innovation Development Office of ARU).  
 
Publication and Dissemination of Research  
On completion of the study, the data will be analysed and tabulated and a Final Study Report 
prepared.  It is ARU policy that the results of the research it supports should be disseminated 
as widely as possible, for the benefit of other researchers and of the wider community.  
 
ARU has established arrangements for ensuring that the results and full anonymised dataset 
are deposited in an on-line repository and made available to other researchers. Researchers 
should consult their supervisors about those arrangements, as to which on-line repository 
would be most suitable for their research area. In this study, data will be stored via the 
internal publications repository known as ARRO. Doctoral students should ensure that their 
thesis (or any other output such as an exhibition or performance) includes an 
acknowledgement of the support they have received from ARU.  
 
Publication of any aspect of the research resulting from an ARU-funded studentship, through 
publications and other forms of media communication, including media appearances, press 
releases and conferences, must acknowledge the support received from the ARU.  

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46 
 
Research students should discuss with their supervisors whether any or all of the results of 
their work should be published.  If a student, or anybody else, publishes any aspect of the 
research resulting from an ARU funded studentship, through publications and other forms of 
printed or electronic media communication, including media appearances, websites, press 
releases and conferences, they must acknowledge the support received from ARU.  
 
Learned societies and other organisations (such as the Institute of Historical Research) collect 
and publish information about doctoral theses completed and in progress. ARU strongly urges 
the submission of relevant information if asked to do so.  
 
It is anticipated that this study will be written in an appropriate journal style, authored by the 
Principal investigator and the student research supervisors, and published in a leading vision 
science or medical journal such as Journal of Vision, Vision Research, British Journal of 
Ophthalmology, Investigative Ophthalmology and Vision Science or Nature. Results will also 
be presented at appropriate scientific and medical conferences such as the Vision Sciences 
Society (VSS) and the Association for Research in Vision and Ophthalmology (ARVO). The 
outcomes and results of this research will be made available to all of the participants of the 
study in a written format using suitable and understandable lay language. It will also be 
possible for the participant to specifically request results after the results have been 
published. 
 
 

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Siderov, J., Waugh, S.J. and Bedell, H.E., 2013. Foveal contour interaction for low contrast 
acuity targets. Vision Research, 77, pp.10–13. 
Smith, A. and Ledgeway, T., 1997. Separate detection of moving luminance and contrast 
modulation: fact or artifact? Vision Research, 37(1), pp.45–62. 
Song, S., Levi, D.M. and Pelli, D.G., 2014. A double dissociation of the acuity and crowding 
limits to letter identification, and the promise of improved visual screening. Journal of Vision, 
14(5), p.3. 
Spiegel, D.P., Li, J., Hess, R.F., Byblow, W.D., Deng, D., Yu, M. and Thompson, B., 2013. 
Transcranial Direct Current Stimulation Enhances Recovery of Stereopsis in Adults With 
Amblyopia. Neurotherapeutics, 10(4), pp.831–839. 
Stuart, J.A. and Burian, H.M., 1962. A Study of Separation Difficulty: Its Relationship to Visual 
Acuity in Normal and Amblyopic Eyes. American Journal of Ophthalmology, 53(3), pp.471–
477. 
Ts’o, D.Y. and Gilbert, C.D., 1988. The Organization of Chromatic and Spatial Interactions in 
the Primate Striate Cortex. The British journal of ophthalmology, 8(5), pp.1712–1727. 
Waugh, S.J., Pelli, D.G., Alvaro, L.A. and Formankiewicz, M.A., 2018. Crowding distance in 
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Wiesel, T.N. and Hubel, D.H., 1963. Single-Cell Responses In Striate Cortex Of Kitten Depreived 
of Vision in One Eye. Journal of Neurophysiology, 26(6), pp.1003–17. 
Witton, C., Talcott, J.B. and Henning, G.B., 2017. Psychophysical measurements in children: 
challenges, pitfalls, and considerations. PeerJ, 5, p.e3231. 
Wong, A.M.F., 2012. New concepts concerning the neural mechanisms of amblyopia and their 
clinical implications. Canadian Journal of Ophthalmology / Journal Canadien d’Ophtalmologie, 
47(5), pp.399–409. 
Wong, E.H., Levi, D.M. and McGraw, P. V., 2001. Is second-order spatial loss in amblyopia 
explained by the loss of first-order spatial input? Vision Research, 41(23), pp.2951–2960. 
Wong, E.H., Levi, D.M. and McGraw, P. V., 2005. Spatial interactions reveal inhibitory cortical 
networks in human amblyopia. Vision Research, 45(21), pp.2810–2819. 
Wu, C. and Hunter, D.G., 2006. Amblyopia: Diagnostic and therapeutic options. American 
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Louisa Haine – Amblyopia research protocol 5.0 
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Appendices 
 
 
 

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Appendix 1 – Documentation 
Research CV for Principal Investigator 
Page 56 
Parent / Guardian Information Sheet 
Page 58 
Participant Information Sheet (PIS) 
Page 62 
Parent / Guardian consent form 
Page 64 
Participant assent form 
Page 65 
Cover Sheet and Data Collection Sheet 
Page 66 
Study poster for ACPOS waiting room 
Page 68 
Insurance Flowchart 
Page 69 
COVID form 
Page 70 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
56 
 
CURRICULUM VITAE 
 
Name:  
 
Mrs Louisa Haine 
Present appointment: (Job title, department, and organisation.) 
 
Post Graduate Researcher, Anglia Vision Research, Anglia Ruskin University, Cambridge. 
Address: (Full work address.) 
 
Louisa Haine, 
Anglia Vision Research, 
Department of Vision and Hearing Sciences, 
Room 407, 
Coslett Building, 
Anglia Ruskin University, 
Cambridge. 
Telephone number: 
Email address: 
 
(01223) 698584 
 
louisa.haine@pgr.anglia.ac.uk 
Qualifications: 
BSc (Hons) Orthoptics 
City and Guilds PTLLS 
City and Guilds CTLLS 
MMedSci (Vision and Strabismus) 
Professional registration: (Name of body, registration number and date of registration.) 
 
HPC – reg no. OR 05763, registered since 01/09/2009 
BIOS – reg no. 3121 since 01/01/2010 
Society for Education and Training, associate status – member no. AH000082, registered 
since 09/04/2013 

Louisa Haine – Amblyopia research protocol 5.0 
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Previous and other appointments: (Include previous appointments in the last 5 years and 
other current appointments.) 
 
01/04/17 – 10/11/17: Specialist Orthoptist, Addenbrookes Hospital, Cambridge. 
01/07/11 – 01/04/17: Lead Orthoptic Clinical Tutor, Addenbrookes Hospital, Cambridge. 
01/09/08 – 01/07/11: Orthoptist, Addenbrookes Hospital, Cambridge. 
Research experience: (Summary of research experience, including the extent of your 
involvement.  Refer to any specific clinical or research experience relevant to the current 
application.) 
 
Taken part in departmental audits including completing questionnaires, obtaining patient 
notes for audit purposes, written a paper on superior oblique myokymia and obtained patient 
consent to use their details for a published case study. 
 
Completed a research project as part of the MMedSci. This involved writing of research 
protocols and information leaflets, obtaining local NHS ethics approval using the IRAS 
system, recruitment of participants, randomisation, assessment and statistical analysis. 
 
Obtained monies via a grant application to the Cambridge Eye Trust, to help fund the 
purchase of equipment necessary for the vision and strabismus MMedSci research project. 
Research training: (Details of any relevant training in the design or conduct of research, for 
example in the Clinical Trials Regulations, Good Clinical Practice, consent or other training 
appropriate to non-clinical research.  Give the date of the training.) 
 
GCP certificate: 16/8/2016 
Epigeum online – Intellectual property in the research context:  03/10/2017 
Epigeum online - Ethics 1: Good Research Practice: 02/10/2017 
 
Relevant publications: (Give references to all publications in the last two years plus other 
publications relevant to the current application.) 
 
August 2014: Poster presentation at the British and Irish Orthoptic Society Scientific 
Conference - Glasgow: ‘A CASE OF CHRONIC SUPERIOR OBLIQUE MYOKYMIA WITH 
COMPENSATORY HEAD POSTURE’. 
Signature: 
Date: 
L.Haine 
26/3/18 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
58 
 
 
 
 
 
INFORMATION FOR PARENTS / GUARDIANS 
 
ARU’s response to COVID -19 pandemic.  
ARU takes its responsibilities regarding COVID-19 seriously. Further details regarding this are 
provided below.  
Test and trace  
As part of ARU’s response to the COVID-19 pandemic, we need to collect personal data from 
you, in order to support the Government’s ‘test and trace’ system. For further information, 
please 
refer 
to 
ARU’s 
Privacy 
Information 
for 
COVID-19 
Management 
at: 
https://aru.ac.uk/privacy-and-cookies/research-participants   
We will ask you to sign a consent form to confirm that you are happy for us to collect this 
information. Further information is provided on this consent form. Please let me know if you 
have any queries regarding this. 
Health & Safety  
It is not advisable for people in the clinically vulnerable or clinical extremely vulnerable 
(shielded) categories to take part in any face to face research.  
It is an ARU requirement that a Risk Assessment (Health and Safety) is carried out for all face 
to face research. Please refer to ARU’s website at https://aru.ac.uk/coronavirus/Covid-secure-
campuses for information about what ARU is doing to manage the risk of Covid-19. 
During this study, the researcher will wear an apron and a mask. The researcher, participant 
and parent will wash their hands upon entering the testing room (which has its own sink and 
sanitising soap) and wear masks. Children under 11 may choose to not wear a mask. Where 
disposable equipment cannot be used, all equipment will be cleaned before and after used. 
Social distancing will also be used throughout testing. 
 
Title of Project: New visual acuity and crowding tests for better detection of amblyopia. 
Secondary title: Examining new vision tests for better detection of childhood visual loss. 
IRAS project ID number: 238449  
 
We would like to invite your child to take part in our research study. Before you as a parent / 
guardian decide, we would like you to understand why the research is being done and what it 
would involve for you and your child.  

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
59 
One of our team will go through the information sheet with you and answer any 
questions you have.  
 
Please talk to others about the study if you wish, and decide whether or not you and your child 
would like to take part. Ask us if there is anything that is not clear.  
 
What is the purpose of the study?  
 
This study aims to investigate whether new changes to vision tests will offer better sensitivity 
for detecting amblyopia (or “lazy eye”) compared to what is currently used.   
Your child has been invited to participate because they have been diagnosed with amblyopia 
or have no visual concerns, and they are the right age for this study. 
 
Who is doing the research? 
 
This research is being conducted by Mrs Louisa Haine under the supervision of Dr Sarah J 
Waugh within the discipline of Vision and Hearing Sciences at Anglia Ruskin University. Mrs 
Haine is a qualified orthoptist and Dr Sarah Waugh is a consultant optometrist.  
 
Does my child have to take part?  
 
No, it is entirely up to your child and you, whether or not you decide to participate. If you do 
decide to take part, both you and your child will be given time to discuss the study with a 
research member of staff and to ask any questions.  As a parent / guardian, you will be asked 
to provide written consent, and your child will be asked if they want to participate, before we 
commence with the research project. 
 
What if myself or my child change our minds?  
 
Your child can withdraw from the study at any time, without having to give a reason. There are 
no negative consequences to yourself or your child should you wish to withdraw. Any data 
already collected will be retained by the researchers, however it will be anonymised so that 
no-one would be able to identify information about any particular individual. 
 
What do we have to do?  
 
You and your child would be required to visit the Anglia Ruskin University Eye Clinic, ideally 
following their routine NHS eye exam, if required, to participate in the research. The research 
only requires one single visit. It would be valuable to us if we could repeat the research after 
additional routine future follow up clinical appointments, if required, however this is completely 
optional, and identical to the first visit. If your child does not attend the hospital eye clinic, your 
child will have their vision and 3D vision measured by a qualified orthoptist prior to 
commencing the research. 
 
During the research session, your child will participate in a number of computer generated 
vision tests. They will be asked to identify the letters / numbers either verbally or by matching 
what they see on a card.  Each eye will be tested.  The tests are designed to be engaging and 
fun, and we use stickers, stamps and praise to encourage your child. 
 
The results of these computer vision tests will be compared to the results of the vision test that 
your child performed during their routine clinical eye appointment. We ask that you consent to 
us as researchers to ask your child’s clinician about these, and access their clinic notes. If 
during research any ‘incidental findings’ are found with these new ‘un-validated’ tests, then 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
60 
these will be reported to your child’s medical team (with your consent) who can re-examine 
your child’s clinically validated results where needed. Please ask the researcher if you would 
like further clarification regarding this.  
 
What are the possible disadvantages and risks / side effects of taking part?  
 
Please advise the researcher if you are concerned that you or your child are at high (clinically 
vulnerable) or very high risk (clinically extremely vulnerable) of contracting COVID-19, so that 
we can consider excluding you from this research study.  If you have appointments in ACPOS 
this is unlikely, but we are happy to discuss this with you.  We take the same precautions to 
minimise risks for all of our research participants as are taken in ACPOS.     
 
The examination would require you and your child to remain at the Anglia Ruskin University 
Eye Clinic, for 30 minutes to 1 hour after the conclusion of your NHS appointment, or we could 
organise a separate visit if you would like us to. The computer safety manual lists several 
medical conditions, which could possibly be “affected by viewing the computer screen”, 
however these are equivalent to viewing a television or using a computer at home. One of the 
vision tests uses a moving background which presents as a flickering / twinkling image, like 
static on a television. Therefore as a precaution, individuals with known epilepsy are excluded 
from this study. 
 
If you are concerned about any potential risks, please ask and we can provide you and your 
child with more information. 
 
What are the possible benefits of taking part?  
 
This study will not directly benefit your child’s vision, but your child will be contributing to our 
research, which is aimed at understanding and better detecting amblyopia (‘lazy eye’) for the 
future. We won’t know the results of our tests until the conclusion of the project, however if we 
feel that any of our findings might benefit your child’s individual clinical care, with your consent, 
we will inform your child’s clinical team.    
 
What if new information becomes available?  
 
Sometimes in the course of a research project new information about the topic under 
investigation becomes available. If this occurs, we will be happy to discuss it with you, so 
please ask if you have questions at any time. You are always free to continue participating in 
our study, or you may wish to withdraw without any negative consequence. 
 
What will happen when the research study is completed?  
 
If you would like us to, we will send written information about our study’s overall findings to 
you once it is completed, in clear, understandable language.  
 
What if something goes wrong?  
 
There are minimal risks involved in your child taking part, similar to those experienced during 
a normal eye test, or in watching television. If someone is harmed during the study, there are 
no special arrangements for compensation. If you have any concerns about this study 
please e-mail Mrs Louisa Haine at lah222@pgr.aru.ac.uk or phone her on 01223 698584.  
Alternatively email her Supervisor Dr Sarah J Waugh at s.j.waugh@hud.ac.uk or phone her 
on 01484 422288.  We will do our best to answer your questions.  

Louisa Haine – Amblyopia research protocol 5.0 
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61 
Will data collected in this study be kept confidential?  
All personal information collected about your child for the purposes of the research project will 
be treated in strictest confidence.  It will be stored securely during the project, accessible only 
to members of the research team, after which physical copies will be destroyed (6 months 
after the conclusion of the study). Digital anonymised copies will be encrypted, stored on 
University protected space for up to 20-years, and only accessible to the research team.  
 
If your child joins the study, some parts of their records and data collected will be looked at 
only by authorised persons (the researcher and members of your child’s clinical team). The 
hospital eye care team and your child’s GP will be notified that your child is taking part in the 
research study, but they will not know about the specific results generated.  
 
What will happen to the results of the research study?  
 
The data measured on your child will be stored using an unidentifiable code from the outset, 
so that no-one outside the research team will know from which person the data comes from.  
Results of this study may be reported at scientific meetings or appear in scientific publications, 
but your child’s data will never be identifiable to them personally. It will be averaged with data 
from others, and will only use an anonymous code as an identifier. Anonymised data only will 
be stored digitally, where it can be shared for the benefit of the future researchers and may 
be used for future analysis and additional research. 
 
Who is organising and funding the research?  
 
The project is organised and funded by Anglia Ruskin University, Cambridge. Some funding 
is available to offer you a £10 Amazon voucher as compensation for your time each time you 
participate. 
 
Who has reviewed the study? 
 
Ethical approval for this study has been given by an independent group of people, called a 
Research Ethics Committee, to protect you and your child’s safety, rights, wellbeing and 
dignity.  This study has been reviewed by Anglia Ruskin University’s Faculty of Science and 
Technology Research Ethics Panel, and also by an NHS REC panel.   If you have any 
complaints or concerns about your childs treatment before, during or after this study then 
you should contact the Chair of the Faculty of Science and Technology Research Ethics 
Committee, Professor Peter Bright (peter.bright@aru.ac.uk ). 
 
Contact for further information: 
 
If you or your child have any questions regarding any aspects of this study, please e-mail 
Mrs Louisa Haine at lah222@pgr.aru.ac.uk or phone her on 01223 698584.  Alternatively, 
please email her Supervisor Dr Sarah J Waugh at s.j.waugh@hud.ac.uk or phone her on 
01484 422288.  
Thank you for taking time to read this information 
 
YOU WILL BE GIVEN A COPY OF THIS FORM TO KEEP, TOGETHER WITH A COPY OF YOUR CONSENT 
FORM. 
 
The conduct of this study has been approved by the Faculty of Science and Technology 
Research Ethics Panel (FREP), Anglia Ruskin University, and  
by an NHS Research Ethics Committee (REC). 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
63 
Do not worry if you cannot remember the name of the number or letter, 
because you can point to it on a card instead. If you need to guess, that is ok 
too. 
 
 
 
 
 
 
 
All of these tests are safe and should not hurt your eyes, but we will have lots 
of rests between your games to make sure you do not get tired. 
 
 
 
 
Have a talk with your parent / guardian about whether you would like to join in 
and if you have any other questions, do please ask. 
 
Thank you for your help. 
 
Louisa Haine: LAH222@pgr.aru.ac.uk   
Tel: 01223 698584 
My Teacher: 
Dr Sarah J Waugh: s.j.waugh@hud.ac.uk  
Tel: 01484 422288 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
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Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
65 
Child’s Assent form 
(To be read aloud to the child) 
 
Title: ‘New visual acuity and crowding tests for better detection 
of amblyopia.' 
IRAS project ID: 238449 
 
Hi.  My name is Louisa. I am a scientist who is trying to learn about how we see. I am interested 
in how children like you see letters and numbers on a vision chart.  
If you agree to be in my study, you will play a game looking at pictures of some letters and 
numbers on a computer screen. You may also look at letters on a chart and some 3D shapes. 
Sometimes they will be easy to see and sometimes hard to see.   
I will ask you to tell me what you see, or you can just point to find a similar picture on my card.  
You will only be asked to do this for a few minutes at a time, and we will have lots of rests in 
between. 
There are no wrong answers. Just tell me what you think you see. 
By being in our study, you will be helping me to understand how children who have eyes like 
yours, see. 
Please have a think, or talk to your parent/carer to help you decide if you want to help us.  I 
will also ask your parent if it is OK for you to take part, but even if they say “yes,” you can still 
say “no” if you don’t want to.  No one will be upset if you don’t.   
Even if you want to start, and then decide to stop, that is okay too. Also, remember that no one 
else outside the room will know what you have said. 
Do you have any questions that you would like to ask me?  
If you have a question later that you did not think of now, you can call me or my teacher, Dr 
Waugh, at (01223) 698 386 or email her at sarah.waugh@aru.ac.uk . 
Would you like to be a part of my study and look at some pictures now?   
 Participant gives clear verbal assent (and can tick the box if they want to) in 
presence of Guardian. Only a definite yes will be taken as consent to participate.    Date 
.................................................... 
The conduct of this research project has been reviewed and approved by the Faculty of 
Science and Technology Research Ethics Panel (FREP), Anglia Ruskin University, and a 
NHS ethics panel 
 
 

Louisa Haine – Amblyopia research protocol 5.0 
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Coversheet 
Participant name:   
 
 
 
 
Participant contact details (phone and/or email):   
 
 
 
 
Participant information sent 
 
 
 
 
 
Y / N 
Research date booked: __________________________________ 
Participant consent received & filed  
 
 
 
Y / N 
Parent / guardian consent received & filed  
 
 
Y / N 
Parent been given copies of consent forms  
 
 
Y / N 
Participant number assigned:  ____________________  
    
Put on database   
 
 
 
 
 
 
Y / N 
Allocated testing group:    
 
  
 
 
 
Y / N 
Testing completed: 
 
 
  
 
 
 
Y / N 
Excluded from study 
 
 
  
 
 
 
Y / N  
Results uploaded to database:  
  
 
 
 
Y / N 
Clinician Letter Sent: 
 
 
 
 
 
 
Y / N 
 
Date……………………………….. 
Parent / guardian sent research findings: 
 
 
 
Y / N
 
Date………………………. 
Parent wishes to claim for travel / parking  
 
 
Y / N  
Reimbursed  
 
 
 
 
 
 
 
Y / N 
 
Amount  - £…………………….. 
Amazon voucher offered instead 
 
 
 
 
Y / NA 
Amazon voucher accepted 
 
 
 
 
 
Y / N 
 
Voucher code…………………….. 
Date participant withdrew consent: …………………………………… 
 

Louisa Haine – Amblyopia research protocol 5.0 
IRAS Number: 238449 
 
 
67 
Data Collection Sheet 
Date: 
 
Participant number: 
 
 
 
Visit number: 
 
Age in months: 
 
Gender:  
 
M / F 
 
Recruited group - delete as appropriate: 
Control / Anisometropic Amblyopia/ Strabismic Amblyopia 
 
Refractive error: 
 
Last clinically tested SLT date: 
 
Visual acuity -  
 
RE: 
 
 
 
LE: 
 
 
 
 
Amblyopia density – delete as appropriate: 
NA / Mod amblyopia (<0.600 IOD) / Severe amblyopia (>0.600 IOD) 
 
Current occlusion regime: 
 
Allocated group: 
Control RE leading / Control LE leading  
 
 Amblyopic eye leading / Fixing eye leading 

Louisa Haine – Amblyopia research protocol 5.0 
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68 
 
 
PARTICIPANTS REQUIRED FOR RESEARCH INTO NEW VISION 
TESTS FOR BETTER DETECTION OF AMBLYOPIA OR “LAZY EYE” 
 
We are looking for patients aged between 3 and 11-years-old to take part in a piece of 
research examining a new type of vision test, which we expect will be better at 
detecting and monitoring amblyopia or “lazy eye”, as it is commonly known. 
 
If you are attending an Addenbrooke’s eye appointment, your child may be invited to 
take part. As a participant in this study, your child would be asked to complete a series 
of different vision tests, in the form of a game. They would be required to complete 
each test with each eye individually, similar to how their eyes are tested during their 
clinical appointments. 
 
It should take no longer than one hour (60 minutes) to complete all the tests, 
depending upon your child’s age and attention span, but might be as short as 30 
minutes. We can also arrange for the tests to occur after your child’s routine clinic 
appointment, in order to minimise disruption to their timetable.  
 
An Amazon voucher of £10 is available for each involvement, as compensation for your 
time and travel expenses. 
 
For more information about this study, please speak to a member of your clinical team 
or contact; 
Louisa Haine – Postgraduate Researcher 
Faculty of Science and Technology, Anglia Ruskin University 
Email: LAH222@pgr.aru.ac.uk 
 
Ethical approval for this study has been granted by Anglia Ruskin University and                                                      
an NHS research and Ethics committee. 
 

Louisa Haine – Amblyopia research protocol 5.0 
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What personal information will we hold? 
• Your name, contact details, dates and times when present on campus. See Government 
Guidance: https://www.gov.uk/guidance/maintaining-records-of-staff-customers-and-visitors-
to-support-nhs-test-and-trace  
How do we use your personal information? 
We use this information for these purposes: 
To inform you if we become aware of a positive case with whom you may have been in close 
contact to allow us to give you further guidance. 
To support the Local Authority and Health Protection Teams in taking additional measures to 
manage the spread of the pandemic. 
Who else might we share your personal information with? 
We will securely share the identifiable data above about cases and potential contacts with 
Local Authority Public Health and Health Protection Teams.  
Who is the data controller for this processing? 
Anglia Ruskin University is the Data Controller. Where we share personal data, the receiving 
authority will also become a Data Controller. 
What is the legal basis for our use of your personal information? 
Your consent 
How long will we keep your personal information? 
21 days in line with government guidance 
Your rights 
The law gives you a number of rights to control what personal information is used by us and 
how it is used by us. 
You can obtain further information about these rights from the Information Commissioner’s 
Office. 
You also have the right to lodge a complaint in relation to this summary notice, the full 
Privacy Notice or our processing activities with the Information Commissioner’s Office. 
Information Commissioner's Office Post: Information Commissioner's Office, Wycliffe House, 
Water Lane, Wilmslow, Cheshire SK9 5AF  
Website: https://ico.org.uk/ Email: casework@ico.org.uk  
Telephone: 0303 123 1113 (local rate) or 01625 545745 (national rate) 
Contact us 
If you wish to exercise any of these rights, you can contact our Data Protection Officer. Data 
Protection Officer  
Email: dpo@aru.ac.uk  
 

Louisa Haine – Amblyopia research protocol 5.0 
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Appendix 2 – Schedule of Procedures 
Procedure 
Visit 
ACPOS clinical 
appointment 
First visit 
Second visit 
(If participant 
opts in) 
Third visit 
(if participant 
opts in) 
Participant 
identification and 
dissemination of 
information 
sheets 
x 
 
 
 
Consent and 
Assent 
 
x 
 
 
Background and 
medical history 
 
x 
x 
x 
Completion of 
modified visual 
acuity tests 
 
x 
x 
x 
 
 
 

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Appendix 3 – Amendment history 
Amendment 
No. 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made