Optimising Visual Acuity Measurement in Macular Degeneration (OPTIMISE)

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: Age Related Macular Degeneration
• Intervention / Treatment: Device: Visual acuity and contrast sensitivity measurement

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Moorfields Eye Hospital NHS Foundation Trust

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; 150 healthy control participants	Device: Visual acuity and contrast sensitivity measurement; 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	Device: Visual acuity and contrast sensitivity measurement; 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	Device: Visual acuity and contrast sensitivity measurement; 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	Device: Visual acuity and contrast sensitivity measurement; 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	Device: Visual acuity and contrast sensitivity measurement; 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	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	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

• Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Study record dates

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: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• 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