Impact of Age-related Macular Degeneration on Daily Living Activitie

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial design

Design model

Single group

Treatments tested in this trial

  • patient-reported outcome

    Other intervention

    Performance of real-life tests and tasks

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Patients with early-stage AMDOther 1 intervention
Group B: Patients with intermediate-stage AMDOther 1 intervention
Group C: 30 healthy volunteersOther 1 intervention
Group D: 30 healthy volunteers with central microdrusens (at risk of developing AMD)Other 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
26 month
2

Validity of content

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

Time frame
26 month
3

Reproducibility of results

Number of patients able to reproduce the same performance tests

Time frame
26 month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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