Optimising Visual Acuity Measurement in Macular Degeneration

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Device: Visual acuity and contrast sensitivity measurement

• Registration Number: NCT04920071
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-25
• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-09
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Visual acuity and contrast sensitivity measurement	150 healthy control participants
AMD Cohort high-contrast VA group i	Visual acuity and contrast sensitivity measurement	Better than 0.4 logMAR
AMD Cohort high-contrast VA group iii	Visual acuity and contrast sensitivity measurement	0.6-0.8 logMAR
AMD Cohort high-contrast VA group ii	Visual acuity and contrast sensitivity measurement	0.4-0.6 logMAR
AMD Cohort high-contrast VA group iv	Visual acuity and contrast sensitivity measurement	0.8-1.0 logMAR

Primary Outcome Measures

Name	Time	Method
Ratio of disease signal (test sensitivity) to measurement noise (variability) in AMD with conventional and Moorfields Acuity Charts	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.

Secondary Outcome Measures

Name	Time	Method
Test-retest variability for the Moorfields Acuity Chart and conventional logMAR visual acuity tests	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.

Trial Locations

Locations (1)

Moorfields Eye Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom