High MyopiaPPO100NCT07101146
100 High Myopia Patient-reported Outcomes (PRO) and Performance Outcomes (PERFO)
A study testing Quality of life questionnaire, Performance Outcomes (PerfO) and Semi-structured interviews in people with High Myopia, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
Trial summary
Prospective, longitudinal, interventional, exploratory, non-randomized, single-center study including patients with pathological myopia . Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- High Myopia
- What is being tested?
- Quality of life questionnaire, Performance Outcomes (PerfO) and Semi-structured interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pathological Myopia and Quality of Life: An Exploratory Study of Patient Outcomes and Perceptions
Prospective, longitudinal, interventional, exploratory, non-randomized, single-center study including patients with pathological myopia .
Read the 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
- to study the parameters (ceiling and floor effects) and assess the reliability of performance tasks in relation to perceived difficulties,
- 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
- Being tested
- Quality of life questionnaire, Performance Outcomes (PerfO), Semi-structured interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnaireOther
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
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 interviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Quality of life questionnaire; Other: Performance Outcomes (PerfO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study startOct 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, longitudinal, interventional, exploratory, non-randomized, single-center study including patients with pathological myopia
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise PHILIPPAKIS, MD, Principal investigator, Hôpital Fondation Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101146
- Sponsor's protocol ID
- P22-06
- Acronym
- PPO100
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathological Myopia and Quality of Life: An Exploratory Study of Patient Outcomes and Perceptions
- ClinicalTrials.gov ID
- NCT07101146
- Acronym / sponsor ID
- PPO100 / P22-06
- Conditions
- High Myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- to study the parameters (ceiling and floor effects) and assess the reliability of performance tasks in relation to perceived difficulties,
- 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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, longitudinal, interventional, exploratory, non-randomized, single-center study including patients with pathological myopia
| Arm | Type | Receives |
|---|---|---|
| Qualitative Phase | Other | Other: Quality of life questionnaire, Other: Performance Outcomes (PerfO), Other: Semi-structured interviewsThe "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. |
| Exploratory Phase | Other | Other: Quality of life questionnaire, Other: Performance Outcomes (PerfO)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life questionnaireThe 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 | Exploratory Phase, Qualitative Phase |
| 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 | Exploratory Phase, Qualitative Phase |
| Semi-structured interviewsSemi-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. | Other | Qualitative Phase |
Primary outcome
Simulator driving test:Evaluation of pedestrian detection performance using peripheral vision
Time frame: 2 months
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.
Locomotion assessment
Time frame: 2 months
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.
Visual search in VR
Time frame: 2 months
Score calculated based on the total number of targets identified in two minutes and the number of mistakes made.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elise PHILIPPAKIS, MD principal investigator
Hôpital Fondation Adolphe de Rothschild
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life questionnaire, Performance Outcomes (PerfO) and Semi-structured interviews in people with High Myopia, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabil BROUK (00 33 1 40 02 11 44, nbrouk@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simulator driving test:Evaluation of pedestrian detection performance using peripheral vision (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.