Visual and Functional Assessment in Low Vision Patients | NCT01876147

Studies
Visual and Functional Assessment in Low Vision Patients

NCT01876147

Sponsor

University of Oxford

Status

Completed

Last Update Posted

Jun 13, 2019Actual

Enrollment

50Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013Actual

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Jun 10, 2013

First Submission Date that Met QC Criteria

Jun 10, 2013

First Posted Date

Jun 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2019

Last Update Posted Date

Jun 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Order of vision tests 1		Undergo testing with BRVT first, FrACT second.
Order of vision tests 2		Undergo testing with FrACT first, BRVT second.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of VA measured with FrACT and BRVT vision tests		Single visit

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert E MacLaren, DPhil	University of Oxford	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oxford University Hospitals NHS Trust		Oxford	Oxfordshire	OX3 9DU	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31058709	Result	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.

ID	Term
D012174	Retinitis Pigmentosa
D008268	Macular Degeneration
D015354	Vision, Low
D014786	Vision Disorders

ID	Term
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D058499	Retinal Dystrophies
D012162	Retinal Degeneration