Impact of Age-related Macular Degeneration on Daily Living Activitie

NCT ID: NCT06333873

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2029-06-30

Brief Summary

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

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with early-stage AMD

30Patients with early-stage AMD

Group Type: OTHER

patient-reported outcome

Intervention Type: OTHER

Performance of real-life tests and tasks

Patients with intermediate-stage AMD

30 with intermediate-stage AMD

Group Type: OTHER

patient-reported outcome

Intervention Type: OTHER

Performance of real-life tests and tasks

30 healthy volunteers

Without AMD risk

Group Type: OTHER

patient-reported outcome

Intervention Type: OTHER

Performance of real-life tests and tasks

30 healthy volunteers with central microdrusens (at risk of developing AMD)

with central microdrusens (at risk of developing AMD)

Group Type: OTHER

patient-reported outcome

Intervention Type: OTHER

Performance of real-life tests and tasks

Interventions

patient-reported outcome

Performance of real-life tests and tasks

Intervention Type: OTHER

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel PAQUES, Pr

Role: PRINCIPAL_INVESTIGATOR

centre Hospitalier Nationald'Ophtalmologie

Central Contacts

Nabil BROUK

Role: CONTACT

nbrouk@15-20.fr

+33140021738

Other Identifiers

P22-09

Identifier Type: -

Identifier Source: org_study_id