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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
Full description
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:
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
The call center will be comprised of NovaSight personnel, protected by a firewall. For the patching group subjects, the call center personnel will contact all subjects' guardians at 1 week (3 to 7 days) to encourage initial compliance with treatment.
For the CureSight treatment group, the call center will contact the subjects' guardians in order to:
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Inclusion criteria
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:
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.
Exclusion criteria
Primary purpose
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Interventional model
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23 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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