NCT05747781

STReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Optic Neuropathy

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-03-01
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2023-02-28
• Last updated: 2023-02-28