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Validation of Questionnaire in Retinal Degeneration

NCT06185517 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2023-12-29

No results posted yet for this study

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.

Conditions

  • Retinal Degeneration

Interventions

DIAGNOSTIC_TEST

Questionnaire translation and validation

Michigan Retinal Degeneration Questionnaire (MRDQ) and the Michigan Vision-Related Anxiety Questionnaire (MVAQ). Validation of a French translation

Sponsors & Collaborators

  • Street Lab

    collaborator UNKNOWN

  • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

    lead OTHER

Principal Investigators

  • Isabelle AUDO · Centre Hospitalier National d'Ophtalmologie

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-01-31
Completion
2025-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06185517 on ClinicalTrials.gov