NCT06333873Not yet recruiting
Impact of Age-related Macular Degeneration on Daily Living Activitie
Validation of Standardized Tasks and Questionnaires to Evaluate and Understand the Impact of Age-related Macular Degeneration on Daily Living Activitie
Source: ClinicalTrials.gov · Last updated 27 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of AMD. However, functional assessment of AMD is most often based solely on visual acuity, and classifications of AMD are based solely on structural markers. There is therefore a need to improve the detection and functional assessment of this vision-threatening eye disease, by complementing and extending the standard assessments of clinical outcomes (COA)
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 26 Jan 2024
- Start date
- Jun 2024
- Primary completion date
- Jun 2029
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Diseases
- Macular degeneration
- NCT number
- NCT06333873
What you commit to
- Study type: Interventional
- Planned participants: 120
- From Jun 2024 to the primary completion date, Jun 2029
- 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.
Prior treatment
- Any concomitant intraocular condition in the study eye (e.g. glaucoma or cataract) that, in the opinion of the investigator, would require surgical intervention during the study to prevent or treat vision loss that may result from this condition or affect the interpretation of study results,
- Participation in any other therapeutic study evaluating a drug,
Other illness
- Subjects taking medication likely to cause motor, visual, vestibular or cognitive disorders (PSA, neuroleptics, etc.) or who could interfere with the study examinations cannot be included in this study,
- Environmental opacity or eye movement disorders (nystagmus) which, in the opinion of the investigator, interfere with the quality of retinal imaging data.
- Known systemic disease which, in the opinion of the investigator, would preclude active participation in the study,
- Subjects with dyslexic reading disorders,
Other
- Pregnant, parturient or breast-feeding women,
- Cognitively impaired subjects, illiterate subjects and subjects who do not speak the national language.
- Subjects subject to a reinforced protection measure or legal safeguard (curatorship, guardianship).
Who the study is looking for
- General criteria for healthy volunteers and AMD patients:
- Male / Female participant,
- Age ≥ 50 at inclusion,
- Able and willing to provide written informed consent and comply with the study protocol, visits and assessments,
- Quality of AO imaging as assessed by rtx1 camera, ● deemed adequate according to the study physician,
- Membership of a social security scheme or beneficiary of such a scheme.
- Specific criteria for the AMD group:
- Geriatric Depression Scale (GDS) questionnaire score ≤ 10 A COGEVIS questionnaire score ≥ 24/30
- Visual acuity greater than 4/10ths
- General criteria for healthy volunteers:
- No detectable visual pathologies
- Best monocular visual acuity (corrected to 100% of the contrast) ≥ 8/10ths before age 70 and ≥ 6/10ths after.
- MMSE score ≥ 20
- Specific criteria for the group of healthy volunteers with central microdrusens:
- No detectable visual pathologies other than the presence of central microdrusens.
- Best monocular visual acuity (corrected to 100% contrast) ≥ 8/10th before age 70 and ≥ 6/10th after.
- MMSE score ≥ 20
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.