Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities

  • STATUS
    Recruiting
  • End date
    Oct 4, 2023
  • participants needed
    87
  • sponsor
    Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Updated on 24 January 2021
gene therapy
retinopathy
other disease
retinal degeneration

Summary

the incidence of the disease of retinal degenerations with loss of photoreceptors (related to old age or genetic) on patients' daily lives, is poorly characterize without standardized means of measurement (usually performed with functional vision or reading tasks).

self-assessment by a quality of life questionnaire correlated with an assessment of emotional state and direct observation of patients during daily life tasks are the two ways used in a scientific framework to collect data on the difficulties encountered by patients in their daily life.

The aim of this project is to determine the behavioral effects of retinitis pigmentosa (RP) by the effects of performance reductions related to adapting to darkness and visual field restriction. Those assessments will be in real conditions but also in virtual reality (VR).

This tool can be used to measure a therapeutic benefit for new treatments (like gene therapy, retinal implants, intra vitreous injections ) for visual loss patients.

Description

This prospective, longitudinal and non-randomized study will be conducted on 2 groups of people: retinitis pigmentosa's patients ( 1st and 2nd phases) and healthy volunteers patients (2nd phase).

The first phase's aim (named pilot phase) is to determine the optimal parameters to achieve the locomotion test. Fifteen RP's eligible patients will be requiring to 4 sessions of 3 hours to perform tests (Two sessions on real conditions and the two others on virtual reality).

The second phase's aim (named validation phase) is to validate tests to assess the impact of peripheral visual impairment on the sensory and motor performance of patients in their daily life. Firstly 15 RP's patients and 15 healthy volunteers will be included in this phase conducted according to a plan of Simon. 21 additional patients will be including on each group in view of the results on the first step in this 2nd phase.

For each patient, the duration of participation will be of 3 months for the first phase and 14 months for the second phase. The study duration is expected to be 50 months.

Details
Condition Retinitis Pigmentosa
Treatment performance of behavioral locomotion tasks phase 1, performance of behavioral locomotion tasks phase 2
Clinical Study IdentifierNCT04448860
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Retinitis Pigmentosa?
Do you have any of these conditions: Do you have Retinitis Pigmentosa??
Gender male or female
Non-syndromic pigmentary retinopathy: diagnosis confirmed by a specialist (RP patients)
Pigmentary retinopathy with different damage's levels of visual field, acuity and sensitivity to contrasts (RP patients)
Visual acuity of both corrected eyes (glasses, lenses) greater than or equal to 8/10 (or 0.1 logMAR) (Healthy volounteers)
Normal semi-automated kinetic visual field (Healthy volounteers)
Not participating in any other clinical trial that may interfere with this study
Sufficient knowledge of the French language to ensure understanding of the tasks to be performed and the instructions received
Social insurance
Consent signed after information by the investigator

Exclusion Criteria

Pregnant woman
Inability to give personal consent
Cataract surgery in the 3 months before inclusion
Amblyopia
Inability to comply with the instructions for the study tasks or to complete the study visits
MMSE score without visual item 20/25 for RP patients
MMSE score with visual item 25/30 for healthy volunteers
Drug treatment which may cause motor, visual or cognitive disorders (neuroleptics, etc.) or which may interfere with study evaluations
Clear my responses

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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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