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Prospective, longitudinal, interventional, exploratory, non-randomized, single-center study including patients with pathological myopia .
This project will be conducted in two phases, with a qualitative study and an exploratory phase.
There is a clinical need to better understand the progression of myopic complications with diffuse choroidal atrophy (DCA Cat. 2) and choroidal patch atrophy (CPA Cat. 3) and their impact on everyday life.
The first phase is a qualitative study whose objectives are
The second phase will consist of a quantitative exploratory pilot study aimed at comparing the performance of diffuse choroidal atrophy (DCA) and choroidal patch atrophy (CPA) patients in order to highlight any differences between the two in tasks involving mobility and obstacle avoidance, visual search, and driving
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qualitative Phase | Other | The "Qualitative" phase, estimated to last six months, will be conducted on a panel of up to 30 patients with hight myopia for the purpose of conducting semi-structured interviews and pre-tests to calibrate the Perf Outcome parameters. |
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| Exploratory Phase | Other | The "Exploratory" phase, estimated to last 18 months, will be conducted on a panel of 70 patients with hight myopia in order to explore the validity of Perf Outcome. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of life questionnaire | Other | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| 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. | 2 months |
| Visual search in VR | Score calculated based on the total number of targets identified in two minutes and the number of mistakes made. | 2 months |
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Inclusion Criteria:
Patients with pathological myopia and diffuse choroidal atrophy (DCA, Cat. 2 Meta PM)
Pathological myopic patients with patch choroidal atrophy (PCA,
Cat. 3 Meta PM):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nabil BROUK | Contact | 00 33 1 40 02 11 44 | nbrouk@15-20.fr |
| Name | Affiliation | Role |
|---|---|---|
| Elise PHILIPPAKIS, MD | Hôpital Fondation Adolphe de Rothschild | Principal Investigator |
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Prospective, longitudinal, interventional, exploratory, non-randomized, single-center study including patients with pathological myopia
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| Performance Outcomes (PerfO) | Other | Three 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.
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| Semi-structured interviews | Other | Semi-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. |
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