100 High Myopia Patient-reported Outcomes (PRO) and Performance Outcomes (PERFO) (PPO100)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Status: Not yet enrolling

Conditions: High Myopia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07101146

P22-06

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Qualitative Phase

Other group

Description:

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.

Treatment:

Other: Semi-structured interviews

Other: Performance Outcomes (PerfO)

Other: Quality of life questionnaire

Exploratory Phase

Other group

Description:

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.

Treatment:

Other: Performance Outcomes (PerfO)

Other: Quality of life questionnaire