Status:
UNKNOWN
Validation of Questionnaire in Retinal Degeneration
Lead Sponsor:
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Collaborating Sponsors:
Street Lab
Conditions:
Retinal Degeneration
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
While inherited retinal diseases are well characterized anatomically and functionally, it is also essential to understand their impact on patients' quality of life, from their ability to perform the t...
Detailed Description
Interventional research of category 2 with minimal risks and constraints. This is a prospective, monocentric, longitudinal, non-randomized study to validate the translation of questionnaires to assess...
Eligibility Criteria
Inclusion
- Male or female
- Age: 18 to 80
- Sufficient knowledge of the French language to ensure understanding of the tasks to be performed and the instructions received.
- Signed consent after being informed by the investigator.
- Affiliation with health insurance.
- Affected by one of the following rare pathologies, with different levels of visual field, acuity and contrast sensitivity impairment:
- Non-syndromic rod-cone dystrophy (retinopathy pigmentosa, RP): diagnosis confirmed by a specialist.
- Non-syndromic rod-cone dystrophy: diagnosis confirmed by a specialist.
- Non-syndromic Stargardt's disease: diagnosis confirmed by a specialist.
- Non-syndromic congenital night blindness: diagnosis confirmed by a specialist.
- Non-syndromic achromatopsia: diagnosis confirmed by a specialist.
Exclusion
- Pregnancy
- Inability to give informed consent.
- Cataract surgery within 3 months of inclusion.
- Hearing impairment that may interfere with comprehension during the interview.
- Functional amblyopia.
- Inability to comply with instructions to perform study tasks or study visits.
- Drug treatment that may cause motor, visual or cognitive impairment (PSAs, neuroleptics, etc.) or that may interfere with study assessments.
- Other uncontrolled ophthalmic conditions that may interfere with evaluation.
- Participation in another clinical trial that may interfere with the present study.
- Patient under guardianship, curatorship or legal protection
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06185517
Start Date
January 1 2024
End Date
January 1 2025
Last Update
December 29 2023
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