Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
135 participants
INTERVENTIONAL
2024-01-31
2025-01-31
Brief Summary
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Detailed Description
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The research will be conducted in two distinct phases:
Comprehension phase and validation phase
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
After an initial translation of the questionnaires into French, the aim of this of this phase is to ensure the level of understanding of each and potential suggestions, during a personal or telephone interview.
Validation phase:
The aim is to validate the French translation of the Michigan Retinal Degeneration Questionnaire (MRDQ) and the Michigan Vision-Related Anxiety Questionnaire (MVAQ), and in particular to assess: internal validity, construct validity, acceptability, reliability, sensitivity, specificity.
DIAGNOSTIC
NONE
Study Groups
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Comprehension Phase
After an initial translation of the questionnaires into French, the aim of this phase is to ascertain the level of understanding of each questionnaire item and any suggestions, during a telephone or face-to-face interview.
Questionnaire translation and validation
Michigan Retinal Degeneration Questionnaire (MRDQ) and the Michigan Vision-Related Anxiety Questionnaire (MVAQ). Validation of a French translation
Validation Phase
The aim is to validate the French translation of the Michigan Retinal Degeneration Questionnaire (MRDQ) and the Michigan Vision-Related Anxiety Questionnaire (MVAQ).
Questionnaire translation and validation
Michigan Retinal Degeneration Questionnaire (MRDQ) and the Michigan Vision-Related Anxiety Questionnaire (MVAQ). Validation of a French translation
Interventions
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Questionnaire translation and validation
Michigan Retinal Degeneration Questionnaire (MRDQ) and the Michigan Vision-Related Anxiety Questionnaire (MVAQ). Validation of a French translation
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Street Lab
UNKNOWN
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
OTHER
Responsible Party
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Principal Investigators
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Isabelle AUDO
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier National d'Ophtalmologie
Central Contacts
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Other Identifiers
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P22-07
Identifier Type: -
Identifier Source: org_study_id