NCT07101146

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 1. to study the parameters (ceiling and floor effects) and assess the reliability of performance tasks in relation to perceived difficulties, 2. to use interviews to gather information on the difficulties reported in everyday life, the causes, and the environmental conditions leading to a reduction in activity in a population of myopic patients with retinal complications. 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

Conditions

• High Myopia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-11-30
• Completion: 2028-11-30
• First posted: 2025-08-03
• Last updated: 2025-08-03