Optimising Visual Acuity Measurement in Macular Degeneration

NCT04920071 | Completed

• 1 other identifier: MULP1001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Test-retest variability for the Moorfields Acuity Chart and conventional logMAR visual acuity tests

  2 years

Study Arms (5)

Control

150 healthy control participants

Device: Visual acuity and contrast sensitivity measurement

AMD Cohort high-contrast VA group i

Better than 0.4 logMAR

Device: Visual acuity and contrast sensitivity measurement

AMD Cohort high-contrast VA group ii

0.4-0.6 logMAR

Device: Visual acuity and contrast sensitivity measurement

AMD Cohort high-contrast VA group iii

0.6-0.8 logMAR

Device: Visual acuity and contrast sensitivity measurement

AMD Cohort high-contrast VA group iv

0.8-1.0 logMAR

Device: Visual acuity and contrast sensitivity measurement

Interventions

Visual acuity and contrast sensitivity measurement DEVICE

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; AMD Cohort high-contrast VA group ii; AMD Cohort high-contrast VA group iii; AMD Cohort high-contrast VA group iv; Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with reduced vision attributable to AMD will be recruited and tested as part of this study.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Visual Acuity

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: June 9, 2021
• Study Start: July 25, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

GB (1)