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OpenTrials
Completed

NCT Number: NCT01876147

Visual and Functional Assessment in Low Vision Patients

Vision testing is a fundamental part of every optometry and ophthalmology assessment. Traditional vision testing charts are not able to measure vision below a certain level. Vision in this range is classified as counting fingers (CF), hand movements (HM) and light perception (LP). These measures are not very accurate or easily quantifiable. They are also poorly understood in terms of impact on quality of life. This study aims to assess new methods for measuring the vision of patients with very low vision.

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Key information

About this study

Assessing very low vision accurately is becoming increasingly important with the increase in research in this area, such as using retinal implants to restore vision. Without being able to accurately measure the change in vision before and after treatment, it is not possible to fully assess the effect of treatment.

The Freiburg Vision Test (FrACT) is a computer based test developed to assess patients down to the LP level. It has been used in research in recent years. The FrACT is suitable for research but is not suitable for a clinical setting. The Berkeley Rudimentary Vision Test (BRVT) works on a similar principal as the FrACT but consists of hand held cards shown to the patient. Little work has been completed on how well the BRVT test works. Results from FrACT and BRVT will be compared in a group of patients with very low vision. This is important to establish how easily research results can be applied to a clinical setting.

Patients will also be asked to complete a daily living survey to better understand the impact of such poor vision on the ability to carry out day to day tasks. This understanding will help guide low vision services for patients as well as help direct low vision research to achieve a useful level of functional vision.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Snellen VA or equivalent ≤ 6/60 in both eyes
  • Patient has capacity to give consent and to undertake vision tests

Exclusion criteria

  • Diagnosis of functional vision loss
  • Unwilling and/or unable to sign informed consent and complete the vision tests

Treatment and study plan

Primary outcomes

  1. Comparison of VA measured with FrACT and BRVT vision tests

    Time frame: Single visit

Secondary outcomes

  1. Relationship between VA and ability to carry out daily living tasks.

    Time frame: Single time point

    Results from a daily living skills survey will be related to VA measured by FrACT testing.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

A Randomised Crossover Study to Assess the Usability of Two New Vision Tests in Patients With Low Vision, and Relationship of the Measures to Daily Living Tasks.

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 12, 2013
Registry last updated
Jun 13, 2019

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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