Status:
UNKNOWN
Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities
Lead Sponsor:
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
the incidence of the disease of retinal degenerations with loss of photoreceptors (related to old age or genetic) on patients' daily lives, is poorly characterize without standardized means of measure...
Detailed Description
This prospective, longitudinal and non-randomized study will be conducted on 2 groups of people: retinitis pigmentosa's patients ( 1st and 2nd phases) and healthy volunteers patients (2nd phase). The...
Eligibility Criteria
Inclusion
- Gender male or female
- Non-syndromic pigmentary retinopathy: diagnosis confirmed by a specialist (RP patients)
- Pigmentary retinopathy with different damage's levels of visual field, acuity and sensitivity to contrasts (RP patients)
- Visual acuity of both corrected eyes (glasses, lenses) greater than or equal to 8/10 (or ≤ 0.1 logMAR) (Healthy volounteers)
- Normal semi-automated kinetic visual field (Healthy volounteers)
- Not participating in any other clinical trial that may interfere with this study
- Sufficient knowledge of the French language to ensure understanding of the tasks to be performed and the instructions received
- Social insurance
- Consent signed after information by the investigator
Exclusion
- Pregnant woman
- Inability to give personal consent
- Cataract surgery in the 3 months before inclusion
- Amblyopia
- Inability to comply with the instructions for the study tasks or to complete the study visits
- MMSE score without visual item ≤ 20/25 for RP patients
- MMSE score with visual item ≤ 25/30 for healthy volunteers
- Drug treatment which may cause motor, visual or cognitive disorders (neuroleptics, etc.) or which may interfere with study evaluations
Key Trial Info
Start Date :
October 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 4 2023
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04448860
Start Date
October 4 2019
End Date
October 4 2023
Last Update
June 26 2020
Active Locations (1)
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1
Centre hospitalier national d'ophtalmologique de 15-20
Paris, France, 75012