Validation of Standardized Test Protocols to Assess the Impact of Visual

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04448860
Study type	Interventional
Source	Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Contact	Tania RILCY
Phone	+33140021126
Email	trilcy@15-20.fr
Status	Recruiting
Phase	N/A
Start date	October 4, 2019
Completion date	October 4, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT01432847` - Cell Collection to Study Eye Diseases
Completed	`NCT04983914` - Retrospective NIS to Evaluate the Patient Benefit of TES
Recruiting	`NCT03845218` - Retinitis Pigmentosa Clinical Measures and Repeatability Testing of Potential Outcome Measures
Completed	`NCT00231010` - Molecular Genetics of Retinal Degenerations
Active, not recruiting	`NCT04611503` - PDE6A Gene Therapy for Retinitis Pigmentosa	Phase 1/Phase 2
Completed	`NCT02909985` - Visual Activity Evoked by Infrared in Humans After Dark Adaptation	N/A
Recruiting	`NCT01914913` - Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa	Phase 1/Phase 2
Completed	`NCT01949623` - Biomarkers In Retinitis Pigmentosa (BIRP)	N/A
Completed	`NCT01835002` - Transcorneal Electrical Stimulation - Multicenter Safety Study	N/A
Completed	`NCT00407602` - Argus® II Retinal Stimulation System Feasibility Protocol	N/A
Completed	`NCT00515814` - Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors	N/A
Completed	`NCT00100230` - DHA and X-Linked Retinitis Pigmentosa	Phase 2
Active, not recruiting	`NCT00378742` - Repository for Inherited Eye Diseases
Terminated	`NCT05085964` - An Open-Label Extension Study to Evaluate Safety & Tolerability of QR-421a in Subjects With Retinitis Pigmentosa	Phase 2
Recruiting	`NCT05805007` - Safety and Tolerability Study of Gene Editing Drug ZVS203e in Participants With Retinitis Pigmentosa	Early Phase 1
Recruiting	`NCT06291935` - Safety and Tolerability of Intravitreal Administration of VG901 in Patients With Retinitis Pigmentosa Due to Mutations in the CNGA1 Gene	Phase 1
Recruiting	`NCT05909488` - Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II	Phase 2/Phase 3
Recruiting	`NCT03078309` - The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients	Early Phase 1
Completed	`NCT04238858` - Effects of Subtenon-injected Autologous Platelet-rich Plasma on Visual Functions in Eyes With Retinitis Pigmentosa	N/A
Active, not recruiting	`NCT01680510` - The Effect of Oral Administration of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms