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

Primary Purpose

Retinitis Pigmentosa

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
performance of behavioral locomotion tasks phase 1
performance of behavioral locomotion tasks phase 2
Sponsored by
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Retinitis Pigmentosa

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Centre hospitalier national d'ophtalmologique de 15-20Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Retinitis Pigmentosa patients

healthy volunteers patients

Arm 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).

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

Outcomes

Primary Outcome Measures

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.
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.
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
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

Secondary Outcome Measures

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
Quality of Life Assessment
Analyze the correlation between the results of patients' quality of life and the results of behavioral tests
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).
Analyze the adverse events during the tasks' assessment
Analyze the adverse events that will be collected during the performance of this study

Full Information

First Posted
May 19, 2020
Last Updated
June 24, 2020
Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
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1. Study Identification

Unique Protocol Identification Number
NCT04448860
Brief Title
Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities
Acronym
PROST
Official Title
Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
October 4, 2023 (Anticipated)
Study Completion Date
October 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
optimal Simon two-stage design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retinitis Pigmentosa patients
Arm Type
Experimental
Arm 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).
Arm Title
healthy volunteers patients
Arm Type
Other
Arm Description
36 patients will be included just in phase 2 (15 in step 1 and 21 in step 2).
Intervention Type
Behavioral
Intervention Name(s)
performance of behavioral locomotion tasks phase 1
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
performance of behavioral locomotion tasks phase 2
Intervention Description
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)
Primary Outcome Measure Information:
Title
Pilot calibration phase in a real environment.
Description
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.
Time Frame
Month 1
Title
Pilot calibration phase in a virtual environment.
Description
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.
Time Frame
Month 1
Title
Validation phase on the motor performance
Description
Validation of tests to assess the impact of peripheral visual impairment on the motor performance of patients in their daily life
Time Frame
Month 12
Title
Validation phase on the sensory performance
Description
Validation of tests to assess the impact of peripheral visual impairment on the sensory performance of patients in their daily life
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Validation of a locomotion test in virtual reality
Description
It is to validate the construction of the test and to determine its performance in discriminating nature, its reproducibility and its sensitivity to change
Time Frame
Day 1 - Month 1- Month 12
Title
Quality of Life Assessment
Description
Analyze the correlation between the results of patients' quality of life and the results of behavioral tests
Time Frame
Day1-Month 1- Month 12
Title
Measures of the evolution of the postural parameters
Description
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).
Time Frame
Day1 - Month 1 - Month 12
Title
Analyze the adverse events during the tasks' assessment
Description
Analyze the adverse events that will be collected during the performance of this study
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tania RILCY
Phone
+33140021126
Email
trilcy@15-20.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hayet SERHANE
Phone
+33140021144
Email
hserhane@15-20.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saddek MOHAND-SAID, MD
Organizational Affiliation
Centre national d'ophtalmologique des 15-20
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier national d'ophtalmologique de 15-20
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saddek MOHAND-SAID, MD
Phone
01 40 02 14 30/31
Email
smohand-said@15-20.fr

12. IPD Sharing Statement

Learn more about this trial

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

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