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NOT YET RECRUITING
NCT07101146
NA

100 High Myopia Patient-reported Outcomes (PRO) and Performance Outcomes (PERFO)

Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

View on ClinicalTrials.gov

Summary

Prospective, longitudinal, interventional, exploratory, non-randomized, single-center study including patients with pathological myopia .

Official title: Pathological Myopia and Quality of Life: An Exploratory Study of Patient Outcomes and Perceptions

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-10

Completion Date

2028-11-30

Last Updated

2025-08-03

Healthy Volunteers

No

Conditions

Interventions

OTHER

Quality of life questionnaire

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.

OTHER

Performance Outcomes (PerfO)

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. * 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.

OTHER

Semi-structured interviews

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.