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

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Status: Unknown

Conditions: Retinitis Pigmentosa

Treatments: Behavioral: performance of behavioral locomotion tasks phase 2; Behavioral: performance of behavioral locomotion tasks phase 1

Study type: Interventional

Funder types: Other

Identifiers

NCT04448860

2019-A00483-54 (Other Identifier)

P19-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

Retinitis Pigmentosa patients

Experimental group

Description:

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).

Treatment:

Behavioral: performance of behavioral locomotion tasks phase 2

Behavioral: performance of behavioral locomotion tasks phase 1

healthy volunteers patients

Other group

Description:

36 patients will be included just in phase 2 (15 in step 1 and 21 in step 2).

Treatment:

Behavioral: performance of behavioral locomotion tasks phase 2