Visual and Functional Assessment in Low Vision Patients

Age-related Macular Degeneration Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876147
• Other study ID #: OxfordVA2013
• Status: Completed
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: October 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Inherited Retinal Dystrophies
• Macular Degeneration
• Optic Nerve Pathology
• Retinal Dystrophies
• Retinitis
• Retinitis Pigmentosa
• Vision, Low

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Trust	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Jolly JK, Gray JM, Salvetti AP, Han RC, MacLaren RE. A Randomized Crossover Study to Assess the Usability of Two New Vision Tests in Patients with Low Vision. Optom Vis Sci. 2019 Jun;96(6):443-452. doi: 10.1097/OPX.0000000000001380. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of VA measured with FrACT and BRVT vision tests		Single visit
Secondary	Relationship between VA and ability to carry out daily living tasks.	Results from a daily living skills survey will be related to VA measured by FrACT testing.	Single time point

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