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

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.

Study Overview

• Status: Recruiting
• Conditions: Retinitis Pigmentosa
• Intervention / Treatment: Behavioral: performance of behavioral locomotion tasks phase 1; Behavioral: performance of behavioral locomotion tasks phase 2

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 87
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tania RILCY; Phone Number: +33140021126; Email: trilcy@15-20.fr

Study Locations

• France
  • Paris, France, 75012
    • Recruiting
    • Centre hospitalier national d'ophtalmologique de 15-20
    • Contact: Saddek MOHAND-SAID, MD; Phone Number: 01 40 02 14 30/31; Email: smohand-said@15-20.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Behavioral: 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); Behavioral: 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)
OTHER: healthy volunteers patients; 36 patients will be included just in phase 2 (15 in step 1 and 21 in step 2).	Behavioral: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of a locomotion test in virtual reality	It is to validate the construction of the test and to determine its performance in discriminating nature, its reproducibility and its sensitivity to change	Day 1 - Month 1- Month 12
Quality of Life Assessment	Analyze the correlation between the results of patients' quality of life and the results of behavioral tests	Day1-Month 1- Month 12
Measures of the evolution of the postural parameters	Evolution of postural's study parameters is performed by an experimental behavioral study, carried out during the same sessions as the main task of locomotion. The participants' postural stability will be correlated with the patient's visual parameters (acuity, visual field).	Day1 - Month 1 - Month 12
Analyze the adverse events during the tasks' assessment	Analyze the adverse events that will be collected during the performance of this study	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Investigators: Principal Investigator: Saddek MOHAND-SAID, MD, Centre national d'ophtalmologique des 15-20

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 4, 2019
• Primary Completion (ANTICIPATED): October 4, 2023
• Study Completion (ANTICIPATED): October 4, 2023

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (ACTUAL): June 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: P19-02; 2019-A00483-54 (OTHER: IDRCB Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No