Back to resultsSTReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient (STRATAL-GL)
Primary Purpose
Optic Neuropathy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pilot Phase: standardized behavioral task
Validation Phase: standardized behavioral task
Sponsored by
About this trial
This is an interventional other trial for Optic Neuropathy
Eligibility Criteria
Inclusion Criteria: Glaucoma patients: Age: 18 - 80 years, Visual acuity of at least 6/10th binocular, Patient followed at Quinze-Vingts and presenting with chronic stable glaucoma defined by the glaucoma ophthalmologist, MMSE questionnaire score ≥ 25/30 or ≥ 16/25 (if the patient no longer drives), Ability to give consent and comply with the study protocol, Person with Social Security coverage. Recruitment of glaucoma patients will be based on the criteria defined by the HPA classification (Appendix) on the basis of the Humphrey visual field, for categorization of patients into three stages of optic neuropathy progression (early stage "1", moderate "2" and advanced "3"). For the optional roadside fitness visit (V4), specific inclusion criteria will be required for this study: the roadside assessment will be performed with volunteers (GL and VS) who report being: Always drivers in possession of a valid driver's license, Driven at least 500 km in the past year. Healthy volunteer: Age: 18 - 80 years. Age and sex matching between healthy volunteers and glaucoma patients (± 5 years). MMSE questionnaire score ≥ 25/30. Visual acuity of at least 10/10th in binocular. Ability to give consent and comply with the study protocol. Person with a Social Security plan. For the roadside fitness visit (V4), specific inclusion criteria will be required for this study: the roadside assessment will be performed with volunteers who declare themselves: Always drivers in possession of a valid driver's license, Driven at least 500 km in the past year. Exclusion Criteria: Pregnant women. Inability to personally give consent. Participants will not have neurodegenerative diseases or any other disease that could interfere with the assessments planned during this study. Participants will not have any other ophthalmologic diseases other than glaucoma. Drug treatments that may cause motor, visual, or cognitive impairment (PSAs, neuroleptics, etc.) or that may interfere with the study assessments. Condition that limits ability to move. Inability to read.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Pilot Phase
Validation Phase
Arm Description
12 patients with glaumatous optic neuropathy
66 patients with glaumatous optic neuropathy 12 subjects with no known visual impairment
Outcomes
Primary Outcome Measures
Discrimination capacity
Number of patients with capacity of discrimintaion compared to healthy volunteers
Reproducibility of performance tests
Number of patients able to reproduce the same performance tests
Analysis reationships between Performance Outcomes (PerfO), Patient-ReportedOutcome (PRO) and Clinical Outcomes.
Number of patients in each situation
Secondary Outcome Measures
Postural control
Number of patients with modification of Romberg quotient to assess whether the central nervous system has re-weighted the weight of visual, vestibular and proprioceptive inputs with the onset of glaucomatous optic neuropathy.
Oculomotricity:
Number of patients with alteration of eye movement parameters during fixation tasks, ocular tracking (number of fixations, fixation error (gain), speed and number of catch-up saccades) and saccades) and ocular saccades.
Full Information
NCT ID
NCT05747781
First Posted
February 2, 2023
Last Updated
February 17, 2023
Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
1. Study Identification
Unique Protocol Identification Number
NCT05747781
Brief Title
STReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient
Acronym
STRATAL-GL
Official Title
Validation of Standardized Tests Allowing the Evaluation of the Impacts of Glaucomatous Optic Neuropathy in Daily Life Activities
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2027 (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
No
5. Study Description
Brief Summary
The impact of glaucomatous optic neuropathy on the daily life of patients is poorly characterized and does not benefit from standardized tests.
The development and validation of new tests could be used to assess the efficacy of innovative treatments for visually impaired patients and/or optimize management strategies.
Detailed Description
This study will be conducted with 2 groups of subjects: glaucoma patients and healthy volunteers.
The objective of this project is to validate performance criteria (PerfO) using standardized tasks to assess the quality of life of patients but also to better judge the severity of glaucoma damage. The fidelity, reproducibility, validity and sensitivity of these new tests will be studied. This study will include two phases: a pilot phase to refine the parameters of the tests for the target population, and a validation phase for the tools.
This study will be performed in two phases: pilot phase and validation phase.
Pilot phase (12 months): 12 glaucoma patients (4 stage 1; 4 stage 2 and 4 stage 3), the objective of this phase is to define the optimal parameters of task content, as well as the conditions of luminosity and contrast.
Validation phase: 66 glaucoma patients classified into 3 groups of 22 patients according to the stage of severity (22 stage 1; 22 stage 2 and 22 stage 3) and 22 healthy volunteers matched for age and sex (matching rules ± 5 years).
The objective of this phase is to validate tests that will allow the evaluation of the impact of peripheral visual impairment on the sensory and motor performances of patients in their daily life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuropathy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, longitudinal, non-randomized, open-label study with glaucoma patients and control group (healthy volunteers)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pilot Phase
Arm Type
Active Comparator
Arm Description
12 patients with glaumatous optic neuropathy
Arm Title
Validation Phase
Arm Type
Placebo Comparator
Arm Description
66 patients with glaumatous optic neuropathy 12 subjects with no known visual impairment
Intervention Type
Behavioral
Intervention Name(s)
Pilot Phase: standardized behavioral task
Intervention Description
Pilot Phase:
Mobility under variable light conditions (scotopic, photopic, glare, dark adaptation), performed in a virtual environment.
Visual search for objects in real life scenes (office, kitchen, living room) performed in a virtual environment.
Ability to drive (UFOV and DVFAT psychophysical tests).
Intervention Type
Behavioral
Intervention Name(s)
Validation Phase: standardized behavioral task
Intervention Description
Validation Phase:
Mobility in variable light conditions (photopic and scotopic), performed in real and virtual environments.
Visual search for objects in real scenes (office, kitchen, bedroom, living room) performed in a virtual environment.
Driving ability (two psychophysical tests UFOV and DVFAT, one supervised road test).
Primary Outcome Measure Information:
Title
Discrimination capacity
Description
Number of patients with capacity of discrimintaion compared to healthy volunteers
Time Frame
6 months
Title
Reproducibility of performance tests
Description
Number of patients able to reproduce the same performance tests
Time Frame
6 months
Title
Analysis reationships between Performance Outcomes (PerfO), Patient-ReportedOutcome (PRO) and Clinical Outcomes.
Description
Number of patients in each situation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Postural control
Description
Number of patients with modification of Romberg quotient to assess whether the central nervous system has re-weighted the weight of visual, vestibular and proprioceptive inputs with the onset of glaucomatous optic neuropathy.
Time Frame
6 months
Title
Oculomotricity:
Description
Number of patients with alteration of eye movement parameters during fixation tasks, ocular tracking (number of fixations, fixation error (gain), speed and number of catch-up saccades) and saccades) and ocular saccades.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Glaucoma patients:
Age: 18 - 80 years,
Visual acuity of at least 6/10th binocular,
Patient followed at Quinze-Vingts and presenting with chronic stable glaucoma defined by the glaucoma ophthalmologist,
MMSE questionnaire score ≥ 25/30 or ≥ 16/25 (if the patient no longer drives),
Ability to give consent and comply with the study protocol,
Person with Social Security coverage.
Recruitment of glaucoma patients will be based on the criteria defined by the HPA classification (Appendix) on the basis of the Humphrey visual field, for categorization of patients into three stages of optic neuropathy progression (early stage "1", moderate "2" and advanced "3").
For the optional roadside fitness visit (V4), specific inclusion criteria will be required for this study: the roadside assessment will be performed with volunteers (GL and VS) who report being:
Always drivers in possession of a valid driver's license,
Driven at least 500 km in the past year.
Healthy volunteer:
Age: 18 - 80 years.
Age and sex matching between healthy volunteers and glaucoma patients (± 5 years).
MMSE questionnaire score ≥ 25/30.
Visual acuity of at least 10/10th in binocular.
Ability to give consent and comply with the study protocol.
Person with a Social Security plan.
For the roadside fitness visit (V4), specific inclusion criteria will be required for this study: the roadside assessment will be performed with volunteers who declare themselves:
Always drivers in possession of a valid driver's license,
Driven at least 500 km in the past year.
Exclusion Criteria:
Pregnant women.
Inability to personally give consent.
Participants will not have neurodegenerative diseases or any other disease that could interfere with the assessments planned during this study.
Participants will not have any other ophthalmologic diseases other than glaucoma.
Drug treatments that may cause motor, visual, or cognitive impairment (PSAs, neuroleptics, etc.) or that may interfere with the study assessments.
Condition that limits ability to move.
Inability to read.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nabil BROUK
Phone
+33140021126
Email
nbrouk@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
Christophe BAUDOUIN, Pr
Organizational Affiliation
Hôpital National de la Vision des15-20
Official's Role
Principal Investigator
12. IPD Sharing Statement
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STReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient
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