We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Visual and Functional Assessment in Low Vision Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01876147
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Retinitis Pigmentosa Age-related Macular Degeneration Optic Nerve Pathology Inherited Retinal Dystrophies

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : August 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Comparison of VA measured with FrACT and BRVT vision tests [ Time Frame: Single visit ]

Secondary Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with low vision attending outpatient clinics in Oxford Eye Hospital.
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876147


Locations
Layout table for location information
United Kingdom
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
University of Oxford
Investigators
Layout table for investigator information
Principal Investigator: Robert E MacLaren, DPhil University of Oxford
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Layout table for additonal information
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01876147    
Other Study ID Numbers: OxfordVA2013
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: October 2018
Keywords provided by University of Oxford:
Low vision
Vision testing
Retinitis Pigmentosa
AMD
 Visual acuity
Poor vision
Quantification
Additional relevant MeSH terms:
Layout table for MeSH terms
Vision, Low
Macular Degeneration
Retinitis
Retinitis Pigmentosa
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases