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Colour Contrast Sensitivity for the Early Detection of Wet Age-related Macular Degereration (CEDAR)

NCT02173496 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 233

Last updated 2019-01-10

No results posted yet for this study

Summary

Neovascular or wet age-related macular degeneration (ARMD) is a retinal disease and is the leading cause of sight loss in the over 50s; it constitutes a major public health problem which will have an increasingly large impact as the population ages, because sight loss has been associated with loss of independence, depression, social isolation, and falls.

Recent advances in medicine, and in particular the approval on behalf of the National Institute for Health and Clinical Excellence (NICE) for use of ranibizumab (Lucentis) in wet ARMD, have allowed this condition to be treated; however success is more likely when treatments occur at a very early stage.

Unfortunately the early stages of wet ARMD do not cause symptoms and most cases are diagnosed when irreversible retinal damage has already occurred.

In all stages of ARMD, even when no symptoms are present and non-invasive techniques currently used in routine clinical practice are not sufficiently sensitive to identify abnormalities, retinal function and possibly anatomy are abnormal.

This study will evaluate techniques that may be useful in flagging subjects with the "preclinical" stages of the disease. This may allow early preventative measures to be taken, in order to stop altogether the onset of blindness.

The study will focus mainly on colour contrast sensitivity, a simple but highly sensitive technique to assess retinal function, to establish if people with wet ARMD can be identified before symptoms develop. Other assessment modalities, evaluating either structure or function of the retina, will also be employed in selected individuals to establish if they may be used in the routine clinic; however it is already known that these modalities are not suitable for all individuals, as they are more demanding time-wise and concentration-wise, and therefore not universally suitable.

Conditions

  • Age Related Macular Degeneration

Interventions

OTHER

Colour Contrast Sensitivity

Reading of numbers or letters from a monitor

Sponsors & Collaborators

  • The Dunhill Medical Trust

    collaborator OTHER

  • Aston University

    lead OTHER

Principal Investigators

  • Antonio Calcagni, MD · Aston University

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02173496 on ClinicalTrials.gov