Visual function in retinal degeneratio

Not Applicable

Completed

• Conditions: Visual function in patients with inherited retinal disease; Eye Diseases

• Registration Number: ISRCTN24016133
• Lead Sponsor: niversity of Oxford

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37226218/ (added 25/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-18
• Study Completion: 2024-01-01
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Patient participants:
1. Participant is willing & able to give informed consent for participation in the study.
2. Male or female, aged 16 years or above, there is no upper age limit.
3. An inherited retinal degeneration diagnosis
4. A minimum of 6/60 standard VA in each eye.
5. Able to participate in visual function testing.

Control participants:
1. Participant is willing & able to give informed consent for participation in the study.
2. Male or female, aged 16 years or above, there is no upper age limit.
3. A minimum standard VA of 6/7.5 in each eye – this will only become apparent once the participant starts the study, if it is clear they do not meet this criterion, they will be excluded from the study and no further testing undertaken.
4. Able to participate in visual function testing.

Exclusion Criteria

Patient participants:
1. Pre-existing amblyopia or squint would exclude that eye, but other eye still eligible
2. History of other eye problems except those relevant to the study, or glasses or contact lenses, if eye problem in just one eye, the other eye is still eligible
3. Been involved in an interventional research trial where they have received a treatment for their eye condition.

Control participants:
1. Pre-existing amblyopia or squint, fellow eye still eligible
2. History of eye problems, eye treatment or eye surgery other than glasses or contact lenses, if in one eye, fellow eye still eligible.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> VIsual function measured at a single time point:<br> 1. Visual acuity<br> 2. Low luminance visual acuity<br> 3. Mesopic microperimetry<br>

Secondary Outcome Measures

Name	Time	Method
<br> Visual function measures and visual field tests measured at a single time point:<br> 1. Moorfields Acuity Chart Test<br> 2. Scotopic Microperimetry<br> 3. Low Luminance Questionnaire<br><br> 4. Obtain qualitative data via semistructured interviews of patient participants in the day following completion of the study tests. The interviews will explore how the tests made the participants feel and whether any changes or improvements can be made to make the tests more acceptable and accessible.<br>