Visual and Functional Assessment in Low Vision Patients

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT01876147
Collaborator
(none)
50
1
31
1.6

Study Details

Study Description

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official 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.
Actual Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Order of vision tests 1

Undergo testing with BRVT first, FrACT second.

Order of vision tests 2

Undergo testing with FrACT first, BRVT second.

Outcome Measures

Primary Outcome Measures

  1. Comparison of VA measured with FrACT and BRVT vision tests [Single visit]

Secondary Outcome Measures

  1. Relationship between VA and ability to carry out daily living tasks. [Single time point]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oxford University Hospitals NHS Trust Oxford Oxfordshire United Kingdom OX3 9DU

Sponsors and Collaborators

  • University of Oxford

Investigators

  • Principal Investigator: Robert E MacLaren, DPhil, University of Oxford

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT01876147
Other Study ID Numbers:
  • OxfordVA2013
First Posted:
Jun 12, 2013
Last Update Posted:
Jun 13, 2019
Last Verified:
Oct 1, 2018

Study Results

No Results Posted as of Jun 13, 2019