STReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient

Official title

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

Overview

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.

Interventions

• 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).
• 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).

Primary outcome measures

• Discrimination capacity [Time frame: 6 months]
• Reproducibility of performance tests [Time frame: 6 months]
• Analysis reationships between Performance Outcomes (PerfO), Patient-ReportedOutcome (PRO) and Clinical Outcomes. [Time frame: 6 months]

Secondary outcome measures (2)

• Postural control [Time frame: 6 months]
• Oculomotricity: [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05747781 · P22-05 · 2022-A02573-40

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗