Optimising Visual Acuity Measurement in Macular Degeneration (OPTIMISE)
March 12, 2024 updated by: Moorfields Eye Hospital NHS Foundation Trust
Quantifying the Disease Signal to Measurement Noise Ratio With the Moorfields Acuity Chart in Age-related Macular Disease
Age-related macular degeneration (AMD) is the leading cause of visual impairment in the UK. The condition is characterised by damage to the region of the retina (macula) responsible for detailed central vision, this leading to problems with tasks such as reading and face-recognition. The ability to accurately measure vision is central to the detection and management of AMD. The most common test (visual acuity) typically requires patients to identify black letters of varying size on a white background, with the smallest letter read representing the limit of vision. Conventional tests are however known to be variable, making it difficult to determine if a true change in vision has occurred.
Previous work has found the Moorfields Acuity Chart, which contains specially constructed letters composed of a black core and white border, to be more sensitive to early AMD compared to standard charts. Despite this advantage, it is unclear if there is an associated increase in measurement variability with the Moorfields Acuity Chart and if this changes with the severity of disease. In this study, the relationship between vision test sensitivity and measurement variability will be quantified with both conventional visual acuity tests and the new Moorfields Acuity Chart to identify the optimal vision test to detect and monitor AMD in the clinic.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom
- Moorfields Eye Hospital NHS Foundation Trust
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Participants with reduced vision attributable to AMD will be recruited and tested as part of this study.
Description
Group 2 - Healthy control participants:
Inclusion criteria will include:
- Absence of ocular disease in either eye
- Male or female, aged 18 years or older
- The absence of significant media opacities
- Ability to understand nature/purpose of the study and to provide informed consent
- Ability to follow instructions and complete the study
- Ability to speak English
Exclusion criteria will include:
- Any systemic disease likely to affect visual performance
- Presence of any ocular disease
- Hearing impairment sufficient to interfere with hearing instructions
- Poor understanding of English language and/or alphabet
- Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control
150 healthy control participants
|
Those subjects who meet the inclusion criteria will undergo the study tests.
These measurements will be performed on one eye only.
Visual acuity will be quantified using two forms of the MAC chart (MAC 1 and 2) and two forms of a conventional letter design chart (C1 and 2).
Contrast sensitivity will be measured using the two forms of the Pelli-Robson chart (CS1 and CS2).
The order with which the test charts will be presented, in addition to the charts used (i.e.
MAC 1 or 2, C1 or 2, and CS1 or 2), will be selected at random.
Finally, a measurement of eye length will be collected using an IOL Master (Carl-Zeiss Meditec, USA).
|
|
AMD Cohort high-contrast VA group i
Better than 0.4 logMAR
|
Those subjects who meet the inclusion criteria will undergo the study tests.
These measurements will be performed on one eye only.
Visual acuity will be quantified using two forms of the MAC chart (MAC 1 and 2) and two forms of a conventional letter design chart (C1 and 2).
Contrast sensitivity will be measured using the two forms of the Pelli-Robson chart (CS1 and CS2).
The order with which the test charts will be presented, in addition to the charts used (i.e.
MAC 1 or 2, C1 or 2, and CS1 or 2), will be selected at random.
Finally, a measurement of eye length will be collected using an IOL Master (Carl-Zeiss Meditec, USA).
|
|
AMD Cohort high-contrast VA group ii
0.4-0.6 logMAR
|
Those subjects who meet the inclusion criteria will undergo the study tests.
These measurements will be performed on one eye only.
Visual acuity will be quantified using two forms of the MAC chart (MAC 1 and 2) and two forms of a conventional letter design chart (C1 and 2).
Contrast sensitivity will be measured using the two forms of the Pelli-Robson chart (CS1 and CS2).
The order with which the test charts will be presented, in addition to the charts used (i.e.
MAC 1 or 2, C1 or 2, and CS1 or 2), will be selected at random.
Finally, a measurement of eye length will be collected using an IOL Master (Carl-Zeiss Meditec, USA).
|
|
AMD Cohort high-contrast VA group iii
0.6-0.8 logMAR
|
Those subjects who meet the inclusion criteria will undergo the study tests.
These measurements will be performed on one eye only.
Visual acuity will be quantified using two forms of the MAC chart (MAC 1 and 2) and two forms of a conventional letter design chart (C1 and 2).
Contrast sensitivity will be measured using the two forms of the Pelli-Robson chart (CS1 and CS2).
The order with which the test charts will be presented, in addition to the charts used (i.e.
MAC 1 or 2, C1 or 2, and CS1 or 2), will be selected at random.
Finally, a measurement of eye length will be collected using an IOL Master (Carl-Zeiss Meditec, USA).
|
|
AMD Cohort high-contrast VA group iv
0.8-1.0 logMAR
|
Those subjects who meet the inclusion criteria will undergo the study tests.
These measurements will be performed on one eye only.
Visual acuity will be quantified using two forms of the MAC chart (MAC 1 and 2) and two forms of a conventional letter design chart (C1 and 2).
Contrast sensitivity will be measured using the two forms of the Pelli-Robson chart (CS1 and CS2).
The order with which the test charts will be presented, in addition to the charts used (i.e.
MAC 1 or 2, C1 or 2, and CS1 or 2), will be selected at random.
Finally, a measurement of eye length will be collected using an IOL Master (Carl-Zeiss Meditec, USA).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ratio of disease signal (test sensitivity) to measurement noise (variability) in AMD with conventional and Moorfields Acuity Charts
Time Frame: 2 years
|
The disease signal to measurement noise ratio (SNR) is defined as the ratio of AMD test sensitivity to the degree of measurement variability for each chart investigated in this study.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test-retest variability for the Moorfields Acuity Chart and conventional logMAR visual acuity tests
Time Frame: 2 years
|
Measurement variability (difference in two measures captured using the same vision test on the same day) will be quantified for each vision test used in this study.
This analysis will also be undertaken for participants with a range of AMD related vision loss.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2019
Primary Completion (Actual)
May 31, 2023
Study Completion (Actual)
May 31, 2023
Study Registration Dates
First Submitted
February 9, 2021
First Submitted That Met QC Criteria
June 3, 2021
First Posted (Actual)
June 9, 2021
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MULP1001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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