STReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient (STRATAL-GL)

Validation of Standardized Tests Allowing the Evaluation of the Impacts of Glaucomatous Optic Neuropathy in Daily Life Activities

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Optic Neuropathy
• Intervention / Treatment: Behavioral: Pilot Phase: standardized behavioral task; Behavioral: Validation Phase: standardized behavioral task

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nabil BROUK; Phone Number: +33140021126; Email: nbrouk@15-20.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pilot Phase; 12 patients with glaumatous optic neuropathy	Behavioral: Pilot Phase: standardized behavioral task; 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).
Placebo Comparator: Validation Phase; 66 patients with glaumatous optic neuropathy 12 subjects with no known visual impairment	Behavioral: Validation Phase: standardized behavioral task; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discrimination capacity	Number of patients with capacity of discrimintaion compared to healthy volunteers	6 months
Reproducibility of performance tests	Number of patients able to reproduce the same performance tests	6 months
Analysis reationships between Performance Outcomes (PerfO), Patient-ReportedOutcome (PRO) and Clinical Outcomes.	Number of patients in each situation	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Investigators: Principal Investigator: Christophe BAUDOUIN, Pr, Hôpital National de la Vision des15-20

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): March 31, 2027
• Study Completion (Anticipated): March 31, 2027

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Estimate): February 28, 2023

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Optic Nerve Diseases
• Other Study ID Numbers: P22-05; 2022-A02573-40 (Registry Identifier: IDRCB-ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No