Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities
NCT ID: NCT04448860
Last Updated: 2020-06-26
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
87 participants
INTERVENTIONAL
2019-10-04
2023-10-04
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Retinitis Pigmentosa patients
Patients with Retinitis Pigmentosa (RP) at different stages of impairment of the visual field, acuity and sensitivity to contrasts 15 patients will be included in phase 1 versus 36 in phase 2 (15 in step 1 and 21 in step 2).
performance of behavioral locomotion tasks phase 1
The performance of behavioral locomotion tasks is performed on 4 visits on pilot phase (2 in real condition and 2 in virtual reality in D1 and M1)
performance of behavioral locomotion tasks phase 2
The performance of behavioral locomotion tasks is performed on 6 visits on validation phase (3 in real condition and 2 in virtual reality in D1, M1 and M12)
healthy volunteers patients
36 patients will be included just in phase 2 (15 in step 1 and 21 in step 2).
performance of behavioral locomotion tasks phase 2
The performance of behavioral locomotion tasks is performed on 6 visits on validation phase (3 in real condition and 2 in virtual reality in D1, M1 and M12)
Interventions
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performance of behavioral locomotion tasks phase 1
The performance of behavioral locomotion tasks is performed on 4 visits on pilot phase (2 in real condition and 2 in virtual reality in D1 and M1)
performance of behavioral locomotion tasks phase 2
The performance of behavioral locomotion tasks is performed on 6 visits on validation phase (3 in real condition and 2 in virtual reality in D1, M1 and M12)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
OTHER
Responsible Party
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Principal Investigators
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Saddek MOHAND-SAID, MD
Role: PRINCIPAL_INVESTIGATOR
Centre national d'ophtalmologique des 15-20
Locations
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Centre hospitalier national d'ophtalmologique de 15-20
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-A00483-54
Identifier Type: OTHER
Identifier Source: secondary_id
P19-02
Identifier Type: -
Identifier Source: org_study_id
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