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

NCT07101146 | Not Yet Recruiting

• 1 other identifier: P22-06
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

High Myopia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Other: Quality of life questionnaire; Other: Performance Outcomes (PerfO); Other: Semi-structured interviews

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.

Other: Quality of life questionnaire; Other: Performance Outcomes (PerfO)

Interventions

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.

Exploratory Phase; Qualitative Phase

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. * 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.

Exploratory Phase; Qualitative Phase

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.

Qualitative Phase

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with pathological myopia and diffuse choroidal atrophy (DCA, Cat. 2 Meta PM)
• 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;
• Presence of diffuse atrophy (category 2 of the Meta-PM classification) in the better eye;
• Affiliated with or covered by a social security system.
• Pathological myopic patients with patch choroidal atrophy (PCA,
• Cat. 3 Meta PM):
• Age ≥ 18 years and ≤ 55 years;
• Patients who consent to be included in the study;
• Examination and follow-up at least one of the participating centers;
• High myopia with an axial length ≥ 26.5 mm in both eyes;
• Presence of patch atrophy (category 3 of the Meta-PM classification) in the better eye;
• Affiliated with or beneficiary of a social security system.

You may not qualify if:

• 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.
• Patients benefiting from legal protection measures.
• Pregnant or breastfeeding women.
• Individuals who may not be able to tolerate the driving simulator.

Sponsors & Collaborators

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: lead

Study Officials

• Elise PHILIPPAKIS, MD

  Hôpital Fondation Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabil BROUK

CONTACT

00 33 1 40 02 11 44; nbrouk@15-20.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 3, 2025
• Study Start: October 1, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2028
• Last Updated: August 3, 2025

Record last verified: 2025-07