Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities
PROST
2 other identifiers
interventional
87
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 4, 2019
CompletedFirst Submitted
Initial submission to the registry
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2023
CompletedJune 26, 2020
May 1, 2020
4 years
May 19, 2020
June 24, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Pilot calibration phase in a real environment.
Defines the optimal parameters of complexity of standardized behavioral tasks thanks to a mobility test in variable light conditions carried out in a real environment.
Month 1
Pilot calibration phase in a virtual environment.
Defines the optimal parameters of complexity of standardized behavioral tasks thanks to a mobility test in variable light conditions carried out in a virtual environment.
Month 1
Validation phase on the motor performance
Validation of tests to assess the impact of peripheral visual impairment on the motor performance of patients in their daily life
Month 12
Validation phase on the sensory performance
Validation of tests to assess the impact of peripheral visual impairment on the sensory performance of patients in their daily life
Month 12
Secondary Outcomes (4)
Validation of a locomotion test in virtual reality
Day 1 - Month 1- Month 12
Quality of Life Assessment
Day1-Month 1- Month 12
Measures of the evolution of the postural parameters
Day1 - Month 1 - Month 12
Analyze the adverse events during the tasks' assessment
through study completion, an average of 1 year
Study Arms (2)
Retinitis Pigmentosa patients
EXPERIMENTALPatients 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).
healthy volunteers patients
OTHER36 patients will be included just in phase 2 (15 in step 1 and 21 in step 2).
Interventions
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)
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
You may qualify if:
- 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
You may not qualify if:
- Pregnant woman
- Inability to give personal consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre hospitalier national d'ophtalmologique de 15-20
Paris, 75012, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saddek MOHAND-SAID, MD
Centre national d'ophtalmologique des 15-20
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2020
First Posted
June 26, 2020
Study Start
October 4, 2019
Primary Completion
October 4, 2023
Study Completion
October 4, 2023
Last Updated
June 26, 2020
Record last verified: 2020-05