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

NCT07101146 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-03

No results posted yet for this study

Summary

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

Conditions

  • High Myopia

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.

Sponsors & Collaborators

  • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

    lead OTHER

Principal Investigators

  • Elise PHILIPPAKIS, MD · Hôpital Fondation Adolphe de Rothschild

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2025-11-30
Completion
2028-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07101146 on ClinicalTrials.gov