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Not Yet Recruiting NCT05747781

STReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient

Conditions: Optic Neuropathy

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

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.

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05747781). StuddyBuddy aggregates publicly available trial information.