Mobility Protocol Adapted for Advanced Visually Impaired Subjects

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Updated on 19 February 2024
retinitis
visual impairment
cognitive disorders
low vision
amblyopia

Summary

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.

Description

This is monocentric study and the total duration of the study is 48 months. The duration of participation for each research subject is 3 months and maximum 4 visits. This is research involving the human type of non-invasive interventional research, with minimal risks and constraints.

This exploratory study will be conducted on a group of patients with Retinitis Pigmentosa at a very advanced stage.

There will be an inclusion visit including a visual assessment and an ophthalmological consultation. Two experimental visits with tests carried out in a real environment including a locomotion and a posture tasks. An end-of-study visit within a maximum of 1 month following the second experimental visit.

Details
Condition Retinitis Pigmentosa, Retinitis Pigmentosa
Age 18-75 years
Treatment Locomotion task, Posturology task SOT (Sensory Organization Test), The quality of life questionnaire
Clinical Study IdentifierNCT04419285
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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