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

ConditionHigh Myopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Quality of life questionnaire

    Other intervention

    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.

  • Performance Outcomes (PerfO)

    Other intervention

    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.

  • Semi-structured interviews

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Qualitative PhaseOther 3 interventions
Group B: Exploratory PhaseOther 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
2 months
2

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.

Time frame
2 months
3

Visual search in VR

Score calculated based on the total number of targets identified in two minutes and the number of mistakes made.

Time frame
2 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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