Informations générales (source: ClinicalTrials.gov)
Design of a Mobility Protocol to Assess the Impact of Visual Pathologies in Daily Life Activities for Subjects With Advanced Visual Deficits (PROMA)
Interventional
N/A
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (Voir sur ClinicalTrials)
mars 2020
juin 2024
29 juin 2024
Retinitis Pigmentosa is characterized by a progressive disappearance of photoreceptors,
responsible for a progressive and severe loss of vision.
People Retinitis Pigmentosa therefore encounter a large number of difficulties in daily
life, specifically for:
- Visual research
- Visuo-motor coordination in tasks requiring fine motor control
- Visuo-motor coordination in mobility tasks
This study aims to assess the difficulties in the daily life of subjects with Retinitis
Pigmentosa at a very advanced stage unsing, quaify of life questionnaires, simplified
locomotion tasks in real situation and a posture task.
They are proposing a new test adapted and carried out in real situations, in binocular
and monocular vision, making it possible to finely assess locomotion especially for "very
low vision" patients.
This test will also ultimately make it possible to better evaluate the effectivements,
that is to say to observe and quantify objectively by a score the performance progression
obtained for locomotion tasks related to the visual recovery generated by the treatment.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHNO DES QUINZE-VINGTS PARIS | Saddek SM MOHAND-SAID, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Retinitis Pigmentosa, non-syndromic, the diagnosis of which has been confirmed by an
ophtmalmologist
- ETDRS visual acuity less than 2/10 (>+0.7 logMAR; <20/100 Snellen)
- Doesn't participate in clinical research that may interfere with this study
- Sufficient knowledge of the French language to ensure a perfect understanding of the
tasks to be performed and the instructions received
- Consent to the study signed after information by the investigator
- Health insurance affiliation
- Retinitis Pigmentosa, non-syndromic, the diagnosis of which has been confirmed by an
ophtmalmologist
- ETDRS visual acuity less than 2/10 (>+0.7 logMAR; <20/100 Snellen)
- Doesn't participate in clinical research that may interfere with this study
- Sufficient knowledge of the French language to ensure a perfect understanding of the
tasks to be performed and the instructions received
- Consent to the study signed after information by the investigator
- Health insurance affiliation
- Pregnant women
- Inability to give personal consent
- Cataract surgery in the 3 months preceding inclusion
- Amblyopia
- Inability to comply with the instructions for carrying out the study tasks or to
complete the study visits
- MMSE score without visual item ≤ 20/25
- Drug treatment which can lead to motor, visual or cognitive disorders (PSA,
neuroleptics,etc.) or which may interfere with the study's evaluations