About this trial
Prospective, longitudinal, interventional, exploratory, non-randomized, single-center study including patients with pathological myopia .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years and ≤ 55 years;
Patient consenting to be included in the study;
Examination and follow-up in at least one of the participating centers;
Severe pathological myopia with an axial length ≥ 26.5 mm in both eyes;
Disqualifiers
Identified genetic syndromic myopia, including Stickler syndromes type 1 and 2 (collagen 2A1 and 11A1), Marfan syndrome (fibrillin), Ehler-Danlos syndrome type 4 (lysyl-protocollagen hydroxylase), and Knobloch syndrome (collagen 18A).
Patient unwilling to participate or be followed up at one of the participating centers.
Binocular visual acuity ≥ 1 logMar (<0.1 on the decimal scale).
Media opacities preventing quality imaging, including cataracts.
Trial design
Parallel
Treatments tested in this trial
Quality of life questionnaire
Other interventionThe NEI-RQL-42 (National Eye Institute Refractive Quality of Life) questionnaire will be self-administered via a secure online platform to assess the impact of pathological myopia on quality of life.
Performance Outcomes (PerfO)
Other interventionThree tests are planned to assess the impact of high myopia on critical aspects of mobility and safety, with the possibility of adjusting their scope based on pilot data. * The first test involves an assessment of driving on a simulator, designed to evaluate the performance of detecting pedestrians in peripheral vision, with and without glare. * The second test focuses on assessing mobility and obstacle avoidance under six levels of brightness. * The third test evaluates visual search ability. It consists of finding spheres in everyday scenes in an apartment with six levels of contrast tested.
Semi-structured interviews
Other interventionSemi-structured interviews will only be offered to patients recruited in Phase 1 Qualitative and aim to further explore the information gathered from the NEI-RQL-42 questionnaire responses and the difficulties encountered during the performance tasks in the laboratory, by exploring in more detail the limitations encountered by patients with pathological myopia in their daily activities. These interviews will help identify the specific causes of the difficulties encountered, as well as the environmental conditions that may create discomfort or increased hardship.
Treatment groups
Trial outcomes
Primary outcomes
Simulator driving test:Evaluation of pedestrian detection performance using peripheral vision
This test aims to evaluate drivers' performance in detecting pedestrians in their peripheral vision,with and without glare. Participants' performance will be measured in terms of speed and accuracy in detecting pedestrians.
Locomotion assessment
This task aims to measure visual abilities to move safely in an environment where the participant finds their way and avoids obstacles present in the course. Performance is measured by walking speed and the accuracy of foot positioning.
Visual search in VR
Score calculated based on the total number of targets identified in two minutes and the number of mistakes made.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: