NCT05747781Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 28 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 2 Feb 2023
- Start date
- 1 Mar 2023
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Diseases
- Glaucoma
- NCT number
- NCT05747781
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Mar 2023 to the primary completion date, 31 Mar 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Pregnant women.
- Inability to personally give consent.
- Inability to read.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.