Clinical trial NCT04448860: Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities
Official title: Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinitis Pigmentosa
Lead sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: optimal Simon two-stage design
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pilot calibration phase in a real environment.
timeFrame: Month 1
measure: Pilot calibration phase in a virtual environment.
timeFrame: Month 1
measure: Validation phase on the motor performance
timeFrame: Month 12
measure: Validation phase on the sensory performance
timeFrame: Month 12
Secondary outcomes:
measure: Validation of a locomotion test in virtual reality
timeFrame: Day 1 - Month 1- Month 12
measure: Quality of Life Assessment
timeFrame: Day1-Month 1- Month 12
measure: Measures of the evolution of the postural parameters
timeFrame: Day1 - Month 1 - Month 12
measure: Analyze the adverse events during the tasks' assessment
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre hospitalier national d'ophtalmologique de 15-20
Study officials:
affiliation: Centre national d'ophtalmologique des 15-20
name: Saddek MOHAND-SAID, MD
role: PRINCIPAL_INVESTIGATOR
References: