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Clinical Trial 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 tasks of daily living to the psychological impact of the disease on patients. Questionnaires (PRO, Patient-Reported Outcomes) are important tools for assessing this impact. However, PROs validated in French are rare, and often poorly adapted to populations with hereditary retinal degeneration. New PROs particularly adapted to retinal degeneration have recently been validated in English: the Michigan Retinal Degeneration Questionnaire (MRDQ) and the Michigan Vision-Related Anxiety Questionnaire (MVAQ). Validation of a French translation will provide a standardized, reliable tool for French-speaking patients, and enable these questionnaires to be used in gene therapy clinical trials, to assess the efficacy of treatments and their impact on patients' quality of life.


Clinical Trial 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 abilities in daily living tasks and the potential psychological repercussions of visual impairment in various hereditary retinal dystrophies. The research will be conducted in two distinct phases: Comprehension phase and validation phase ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06185517
Study type Interventional
Source Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Contact Nabil BROUK
Phone +331 40 02 11 26
Email nbrouk@15-20.fr
Status Not yet recruiting
Phase N/A
Start date January 2024
Completion date January 2025

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