STReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient

Optic Neuropathy Clinical Trial

— STRATAL-GL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05747781
• Other study ID #: P22-05
• Secondary ID: 2022-A02573-40
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: February 2023
• Source: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Contact: Nabil BROUK
• Phone: +33140021126
• Email: nbrouk[@]15-20.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Optic Nerve Diseases
• Optic Neuropathy

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Outcome

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