Visual and Functional Assessment in Low Vision Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Oxford
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01876147
First received: June 10, 2013
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Comparison of VA measured with FrACT and BRVT vision tests [ Time Frame: Single visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between VA and abililty to carry out daily living tasks. [ Time Frame: Single time point ] [ Designated as safety issue: No ]
    Results from a daily living skills survey will be related to VA measured by FrACT testing.


Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Order of vision tests 1
Undergo testing with BRVT first, FrACT second.
Order of vision tests 2
Undergo testing with FrACT first, BRVT second.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876147

Locations
United Kingdom
Oxford University Hospitals NHS Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Jasleen K Jolly, MSc       enquiries@eye.ox.ac.uk   
Principal Investigator: Robert E MacLaren, MB ChB DPhil         
Sub-Investigator: Jasleen K Jolly, MSc         
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Robert E MacLaren, DPhil University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01876147     History of Changes
Other Study ID Numbers: OxfordVA2013
Study First Received: June 10, 2013
Last Updated: June 18, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
Low vision
Vision testing
Retinitis Pigmentosa
AMD
Visual acuity
Poor vision
Quantification

Additional relevant 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
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014