Eye-tracking Based Amblyopia Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Best-Corrected Visual Acuity of Fellow Eye
研究概览
简要总结
An Eye-Tracking-Based Binocular Amblyopia Technology Improves Both Visual Acuity and Binocularity
Screening A child is considered for the study after undergoing a standard of care and study-specific eye examinations (by a study investigator as part of the standard of care) that identify amblyopia appearing to meet the eligibility criteria. The study will be discussed with the child's parent(s) or guardian(s) (referred to subsequently as parent (s)). Parent(s) who express an interest in the study will be given a copy of the informed consent form to read. Written informed consent must be obtained from a parent and child prior to performing any study-specific procedures that are not part of the child's routine care.
On screening visit, eligibility assessment, medical history, Demographic data, Refraction and Cycloplegia, Demonstration suitability using the CureSight, ATS Diplopia Questionnaire, Symptom Survey Distance VA Testing, Ocular Alignment Testing, Near VA Testing, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional).
All eligible subjects enrolled in the study will be followed for 24 weeks of training followed by 52 weeks of follow-up.
24 weeks: Binocular treatment 90 minutes per day, 5 days per week for 12 weeks followed by 90 minutes per day, 3 days per week for an additional 12 weeks
Follow up visits
- Visit 1: 4 weeks ± 1 week
- Visit 2: 8 weeks ± 1 week
- Visit 3: 12 weeks ± 1 week
- Visit 4: 24 weeks ± 1 week (primary endpoint)
- Optional Visit 5: 52 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes)
详细描述
The Study Purpose is to evaluate the efficacy and safety of a novel binocular eye-tracking-based passive home treatment system delivering personalized amblyopia therapy.
Methods: Real-time foveal area blur was induced on the dominant eye of 20 participants (aged 4-15 years) with anisometropic, strabismic (<5 PD) or mixed amblyopia. Subjects were trained over 12 weeks with 5 weekly sessions and then for an additional 12 weeks with 3 weekly sessions. Primary outcome was the improvement in best-corrected visual acuity (BCVA) and stereo acuity. Secondary outcomes were adherence, improvement persistence, and patient-reported comfort.
Screening A child is considered for the study after undergoing a standard of care and study-specific eye examinations (by a study investigator as part of the standard of care) that identify amblyopia appearing to meet the eligibility criteria. The study will be discussed with the child's parent(s) or guardian(s) (referred to subsequently as parent (s)). Parent(s) who express an interest in the study will be given a copy of the informed consent form to read. Written informed consent must be obtained from a parent and child prior to performing any study-specific procedures that are not part of the child's routine care.
On screening visit, eligibility assessment, medical history, Demographic data, Refraction and Cycloplegia, Demonstration suitability using the CureSight, ATS Diplopia Questionnaire, Symptom Survey, Distance VA Testing, Ocular Alignment Testing, Near VA Testing, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional).
All eligible subjects enrolled in the study will be followed for 24 weeks:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 4 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following criteria must be met for a child to be enrolled in the study:
- •Age 4 to 40 years male and female
- •Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
- •Must have refractive error correction (based on a cycloplegic refraction completed within the last 7 months)
- •Spectacle correction meeting the above criteria must be worn For at least 16 weeks OR until distance VA stability is documented (defined as <0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart).
- •VA, measured in each eye without cycloplegia in current spectacle correction using the Lea symbol per ATS VA protocol for children < 7 years and the EETDRS VA protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows:
- •Visual acuity in the amblyopic eye <1.0 logMAR (20/200)
- •Best-corrected dominant-eye VA <0.2
- •Interocular difference ≥ 2 logMAR lines
- •Heterotropia with a near deviation of <5∆ (measured by SPCT) in habitual correction (Angles of ocular deviation >4∆ are not allowed because large magnitudes of the deviation would compromise successful alignment of the dichoptic stimuli.)
- •Passing a dedicated 10 min in-clinic performance ability test to assure suitable eye tracking performance (validity of eye tracking data >90% and successful calibration process).
- •Subjects and families eligible for clinic visits over duration of study.
- •Subject in general good health and able, as per investigator decision, to comply with study visits and protocol procedures and wear refractive correction and has access to wireless internet at home which is able to support the CureSight treatment (loaned by sponsor).
- •Signed and dated informed consent form.
- •Parent and participant understand and are willing to comply with study procedures and will be available for the duration of the study.
排除标准
- •Myopia greater than -6.00 D. spherical equivalent in either eye.
- •Known skin reactions to patch or bandage adhesives.
- •Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator).
- •Any condition that might interfere with eye tracking, such as ptosis
- •Any reported anatomic ocular anomaly (e.g., small lens opacity, myelinated nerve fiber layer).
- •Previous intraocular or refractive surgery.
- •Heterophoria with a total near deviation of ≥10Δ (measured by PACT
研究组 & 干预措施
Study arm - Binocular CureSight
Using binocular treatment device 90 min a day 5 times a week for 12 weeks following by 90 min a day 3 times a week for additional 12 weeks
干预措施: CureSight (Device)
结局指标
主要结局
Best-Corrected Visual Acuity of Fellow Eye
时间窗: 24 weeks
Mean visual acuity change from baseline Using LogMAR LEA symbols for participants \< 7 years of age and LEA numbers for participants ≥ 7 years of age
Best-Corrected Visual Acuity of Amblyopic Eye
时间窗: 24 weeks
Mean visual acuity change from baseline Using LogMAR LEA symbols optotype for participants \< 7 years of age and LEA numbers optotype for participants ≥ 7 years of age
次要结局
- Adherence(4, 8, 12, and 24 weeks)
- Amblyopic eye best-corrected visual acuity(4, 8, 12, and 24 weeks)
- Stereoacuity(4, 8, 12, and 24 weeks)