inherited retinal dystrophy
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main parameter is the test-retest variability in microperimetry, demonstrated as the change average threshold (dB) between two repeated measurements of macular sensitivity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the changes in other functional and structural outcome measures between repeated measurements. The functional measures include the test-retest variability of best-corrected visual acuity under different light intensities, visual field, fixation stability, and reported quality of life. The structural parameters include test-retest variabilities of parameters measured on SD-OCT and fundus autofluorescence. | — |
Countries
Netherlands
Outcome results
None listed