Study on test-REtest reliability in Patients with inheritEd retinAl dysTrophies (REPEAT study)
- Conditions
- inherited retinal dystrophy10047060
- Registration Number
- NL-OMON51638
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
In order to be eligible to participate in this study as a visually-impaired
patient, a subject must meet all of the following criteria:
• Willing and able to provide informed consent (IC) for the participation in
the study;
• Minimum age of 16 years;
• Clinical diagnosis of IRD with BCVA using ETDRS of >=20/50 Snellen equivalent;
• Willing and able to undergo ophthalmic examinations at two separate occasions;
• No ocular or non-ocular disease/disorder that may influence the results of
the measurements.
In order to be eligible to participate in this study as a low-vision patient, a
subject must meet all of the following criteria:
• Willing and able to provide informed consent (IC) for the participation in
the study;
• Minimum age of 16 years;
• Clinical diagnosis of IRD with BCVA using ETDRS of <20/50 Snellen equivalent;
• Willing and able to undergo ophthalmic examinations at two separate occasions;
• No ocular or non-ocular disease/disorder that may influence the results of
the measurements
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• The last measured BCVA in the better-seeing eye is light-perception;
• (History of) ocular of non-ocular disease/disorder that may influence the
results of the measurements (e.g. amblyopia);
• Known allergy or intolerance for ocular anesthetic eye drops oxybuprocaine
0.4% or mydriatics tropicamide 0.5% and/or phenylephrine 5%;
• Participation in another research study involving an investigational
medicinal product related to their ocular health.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main parameter is the test-retest variability in microperimetry,<br /><br>demonstrated as the change average threshold (dB) between two repeated<br /><br>measurements of macular sensitivity.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include the changes in other functional and structural<br /><br>outcome measures between repeated measurements. The functional measures include<br /><br>the test-retest variability of best-corrected visual acuity under different<br /><br>light intensities, visual field, fixation stability, and reported quality of<br /><br>life. The structural parameters include test-retest variabilities of parameters<br /><br>measured on SD-OCT and fundus autofluorescence. </p><br>