Impact of Age-related Macular Degeneration on Daily Living Activitie

NCT06333873 | Not Yet Recruiting

• 1 other identifier: P22-09
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (3)

• Validity of criteria

  Number of patients with capacity of discrimintaion compared to healthy volunteers. ROC (receiver operating characteristic curve), which illustrates the diagnostic capacity of a binary classification system as a function of the variation in its discrimination threshold. The ROC curve is created by plotting the rate of true positives versus the false-positive rate for different thresholds. The index used to characterize a test's of a test is the air under the curve

  26 month

• Validity of content

  number of paticipants with capacity to execute questionnaires and daily real-life task

  26 month

• Reproducibility of results

  Number of patients able to reproduce the same performance tests

  26 month

Study Arms (4)

Patients with early-stage AMD

OTHER

30Patients with early-stage AMD

Other: patient-reported outcome

Patients with intermediate-stage AMD

OTHER

30 with intermediate-stage AMD

Other: patient-reported outcome

30 healthy volunteers

OTHER

Without AMD risk

Other: patient-reported outcome

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

OTHER

with central microdrusens (at risk of developing AMD)

Other: patient-reported outcome

Interventions

patient-reported outcome OTHER

Performance of real-life tests and tasks

30 healthy volunteers; 30 healthy volunteers with central microdrusens (at risk of developing AMD); Patients with early-stage AMD; Patients with intermediate-stage AMD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General criteria for healthy volunteers and AMD patients:
• Male / Female participant,
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: lead

MeSH Terms

Conditions

Macular Degeneration

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Michel PAQUES, Pr

  centre Hospitalier Nationald'Ophtalmologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabil BROUK

CONTACT

+33140021738; nbrouk@15-20.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study including healthy volunteers and patients with AMD

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: March 27, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 27, 2024

Record last verified: 2024-03