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NCT Number: NCT06333873

Impact of Age-related Macular Degeneration on Daily Living Activitie

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)

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

patient-reported outcome

Other

Performance of real-life tests and tasks

Primary outcomes

  1. Validity of criteria

    Time frame: 26 month

    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

  2. Validity of content

    Time frame: 26 month

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

  3. Reproducibility of results

    Time frame: 26 month

    Number of patients able to reproduce the same performance tests

Study contacts

Contact information is provided by the study sponsor or research team.

Nabil BROUK

CONTACT

[email protected]

+33140021738

Sponsors and collaborators

Lead sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Other

Registry information

Official study title

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

Acronym: AMDAY

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 27, 2024
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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