Feasibility and Tolerability Study of Wearing a Miniaturized Smart Contact Lens With Healthy Subjects and Patients With Stargardt's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Occurrence rate of adverse events, unexpected adverse events or serious adverse events
研究概览
简要总结
Oculometry is becoming increasingly popular in fields such as enhanced reality and healthcare, but remains limited by complex devices that are poorly adapted to the needs of users, particularly the visually impaired. This research proposes to explore a smart contact lens (SCL)-based system to overcome these limitations, particularly for people with central visual deficits such as Stargardt's disease.
详细描述
Eye tracking is becoming increasingly important in fields such as augmented reality such as augmented reality, virtual reality and healthcare (orthoptic rehabilitation), but is still limited by complex measurement methods that meet user needs.
In this context, the proposed research aims to study the feasibility of a system based on a smart contact lens that overcomes several overcome many of the limitations of current oculometers (sensitivity to environmental sensors, size, performance, etc.) and even more so when used by visually impaired people suffering from central vision deficits central vision deficit such as Stargardt's disease. Whether to eccentric fixation or to transmit relevant information about the environment relevant information about their environment, it is necessary to know direction of gaze. Unfortunately, current solutions are not always compatible with the difficulties faced by visually impaired and the SCL system could be a viable and effective solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Stargardt disease
- •Age: 18 - 70 ;
- •Juvenile form of Stargardt's disease manifested by decreased visual acuity;
- •Visual acuity greater than or equal to 20/400 in binocular vision;
- •MMSE score without visual item ≥ 20/25 ;
- •Eyes whose palpebral opening and ocular surface and its appendages allow the wearing of a scleral lens;
- •Sufficient knowledge of the French language.
- •Ability to give express, free and informed consent in person, after having received adequate information;
- •Ability to comply with protocol requirements;
- •Person covered by Health Insurance.
- •Healthy volunteers:
- •Age: 18 - 70 years;
- •Age- and sex-matched healthy volunteers to subjects with Stargardt's disease (± 5 years);
- •MMSE score with visual items ≥ 25/30 ;
- •Eyes with palpebral opening and ocular surface and appendages suitable for scleral lens wear;
- •Visual acuity of at least 10/10 in binocular vision;
- •Sufficient knowledge of the French language;
- •Ability to give personal, express, written, free and informed consent after receiving adequate information ;
- •Ability to comply with protocol requirements;
- •Person covered by Health Insurance.
排除标准
- •For all participantsPersons referred to in articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons : pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or curatorship);
- •Participants with neurodegenerative diseases or any other disease that could interfere with the planned evaluations during this study;
- •Participants with ophthalmological diseases other than Stargardt's disease;
- •Participants with a history of cleft palate, corneal infection, irregular cornea (such as keratoconus) and severe dry eye syndrome as determined by the ophthalmologist;
- •Participants allergic or sensitive to methyl acrylic poly methacrylate (PMMA) or to any of the components of the Re-See lens;
- •Participants allergic to tropicamide, atropine or its derivatives
- •Participants at risk of angle-closure glaucoma;
- •Participants allergic to sodium fluorescein;
- •Suspicion of transmissible spongiform encephalopathy;
- •Medications that may cause motor, visual or cognitive disorders (neuroleptics, etc.) or that may interfere with study evaluations;
- •Participation in another clinical trial that could interfere with the present study;
- •Inability to follow instructions or read. ☞Wearing glasses or contact lenses is not a non inclusion criterion.
结局指标
主要结局
Occurrence rate of adverse events, unexpected adverse events or serious adverse events
时间窗: 45 days
Ophthalmological consultation (including slit-lamp corneal examination) and subject interrogation. Each reported event will be analyzed to monitor its evolution (resolution or not, necessary treatments...) and to estimate the imputation with the wearing of the LCS lens.
Ergonomics evaluation
时间窗: 45 days
To evaluate the ergonomics: comfort, acceptability and usefulness of the SCL lens with subjects suffering from central vision deficit (Stargardt's disease) and healthy control subjects, we will use the satisfaction questionnaire we have specially designed. Analysis of the results of the close-ended and semi-open-ended questions will enable us to answer this question.
次要结局
未报告次要终点