Impact of Age-related Macular Degeneration on Daily Living Activitie

Official title

Validation of Standardized Tasks and Questionnaires to Evaluate and Understand the Impact of Age-related Macular Degeneration on Daily Living Activitie

Overview

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)

Detailed description

Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study, including healthy volunteers and patients with Age-Related Macular Degeneration

Interventions

• Other patient-reported outcome
  Performance of real-life tests and tasks

Primary outcome measures

• Validity of criteria [Time frame: 26 month]
• Validity of content [Time frame: 26 month]
• Reproducibility of results [Time frame: 26 month]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• Pregnant, parturient or breast-feeding women,
• 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.
• 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,
• Known systemic disease which, in the opinion of the investigator, would preclude active participation in the study,
• Participation in any other therapeutic study evaluating a drug,
• Cognitively impaired subjects, illiterate subjects and subjects who do not speak the national language.
• Subjects with dyslexic reading disorders,
• Subjects subject to a reinforced protection measure or legal safeguard (curatorship, guardianship).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06333873 · P22-09

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗