NCT01876147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 13, 2019

Status Verified

October 1, 2018

Enrollment Period

2.6 years

First QC Date

June 10, 2013

Last Update Submit

June 12, 2019

Conditions

Keywords

Low visionVision testingRetinitis PigmentosaAMDVisual acuityPoor visionQuantification

Outcome Measures

Primary Outcomes (1)

  • Comparison of VA measured with FrACT and BRVT vision tests

    Single visit

Secondary Outcomes (1)

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

    Single time point

Study Arms (2)

Order of vision tests 1

Undergo testing with BRVT first, FrACT second.

Order of vision tests 2

Undergo testing with FrACT first, BRVT second.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with low vision attending outpatient clinics in Oxford Eye Hospital.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related 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.

Related Links

MeSH Terms

Conditions

Retinitis PigmentosaMacular DegenerationVision, LowVision Disorders

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert E MacLaren, DPhil

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 13, 2019

Record last verified: 2018-10

Locations