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Completed

NCT Number: NCT04920071

Optimising Visual Acuity Measurement in Macular Degeneration

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Registry information

Official study title

Quantifying the Disease Signal to Measurement Noise Ratio With the Moorfields Acuity Chart in Age-related Macular Disease

Acronym: OPTIMISE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2021
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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