Pathological Myopia and Quality of Life: An Exploratory Study of Patient Outcomes and Perceptions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Simulator driving test:Evaluation of pedestrian detection performance using peripheral vision
研究概览
简要总结
Prospective, longitudinal, interventional, exploratory, non-randomized, single-center study including patients with pathological myopia .
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Qualitative Phase
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.
干预措施: Quality of life questionnaire (Other)
Qualitative Phase
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.
干预措施: Performance Outcomes (PerfO) (Other)
Qualitative Phase
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.
干预措施: Semi-structured interviews (Other)
Exploratory Phase
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.
干预措施: Performance Outcomes (PerfO) (Other)
Exploratory Phase
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.
干预措施: Quality of life questionnaire (Other)
结局指标
主要结局
Simulator driving test:Evaluation of pedestrian detection performance using peripheral vision
时间窗: 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
时间窗: 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
时间窗: 2 months
Score calculated based on the total number of targets identified in two minutes and the number of mistakes made.
次要结局
未报告次要终点