A Prospective, Multicenter, Randomized, Masked, Controlled Pivotal Trial to Assess the Safety and Effectiveness of an Eye-Tracking-Based Treatment for Amblyopia Under Binocular Conditions Versus the Standard of Care, Monocular Deprivation Treatment (Occlusive Patching)

NovaSight1 site in 1 country23 target enrollmentMarch 31, 2021

Overview

Brief Summary

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 standard of care) that identifies 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 / assent 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-Randot, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional)

Randomization The EDC and data management will construct a Master Randomization List using a permutated block design stratified by initial visual acuity in the amblyopic eye and age which will specify the order of treatment group assignments. Randomization will be managed directly by the eCRF platform.

All eligible subjects enrolled in the study will be followed for 16 weeks. Subjects will be randomly assigned in a 1:1 allocation to one of the following treatment groups for 16 weeks:

Binocular treatment 90 minutes per day, 5 days per week
Patching group: Patching 2 hours per day, 7 days per week.

Follow up visits

1-week phone call (4 to 8 days from randomization) to inquire about issues with the CureSight system (if applicable) and to encourage compliance with treatment for all groups (to be completed by site personnel)
Visit 2: 4 weeks ± 1 week
Visit 3: 8 weeks ± 1 week
Visit 4: 12 weeks ± 1 week
Visit 5: 16 weeks ± 1 week (primary endpoint)
Unmasking of primary outcome results
For each individual subject, clinician's decision regarding:

Treatment or control cessation and follow-up; or, Control (patching) continuation with same modality (more improvement desired); or, Cross-over to a different treatment (avoid missing the optimal window of opportunity in young age)

•Optional Visit 6: 28 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes

Detailed Description

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 standard of care) that identifies 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 / assent 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-Randot, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional) Randomization The EDC and data management will construct a Master Randomization List using a permutated block design stratified by initial visual acuity in the amblyopic eye and age which will specify the order of treatment group assignments. Randomization will be managed directly by the eCRF platform. All eligible subjects enrolled in the study will be followed for 16 weeks. Subjects will be randomly assigned in a 1:1 allocation to one of the following treatment groups for 16 weeks: 1. Binocular treatment 90 minutes per day, 5 days per week 2. Patching group: Patching 2 hours per day, 7 days per week. Follow up visits * 1-week phone call (4 to 8 days from randomization) to inquire about issues with the CureSight system (if applicable) and to encourage compliance with treatment for all groups (to be completed by site personnel) * Visit 2: 4 weeks ± 1 week * Visit 3: 8 weeks ± 1 week * Visit 4: 12 weeks ± 1 week * Visit 5: 16 weeks ± 1 week (primary endpoint) * Unmasking of primary outcome results * For each individual subject, clinician's decision regarding: Treatment or control cessation and follow-up; or, Control (patching) continuation with same modality (more improvement desired); or, Cross-over to a different treatment (avoid missing the optimal window of opportunity in young age) •Optional Visit 6: 28 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes) 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: 1. Assist first time setup at home over the phone 2. Provide technical support by phone in case of system malfunction or any other query or problem appearing during treatment 3. Respond to compliance notifications of the software and contact the subject's guardians when needed in order to encourage compliance 4. Answer any questions that arise by the subjects or guardians. Permission for such contacts will be included in the Informed Consent Form. The call center personal will be exposed to the following details, contact information, email and phone number.

Registry

clinicaltrials.gov

Start Date

March 31, 2021

End Date

May 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NovaSight

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The following criteria must be met for a child to be enrolled in the study:
•Age 4 to \<9 years male and female
•Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
•Criteria for strabismic amblyopia: At least one of the following must be met:
•Presence of a heterotropia on examination at distance or near fixation (with or without optical correction, must be no more than 5 PD by SPCT at near fixation
•Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
•Criteria for anisometropia: At least one of the following criteria must be met:
•≥1.00 D difference between eyes in spherical equivalent
•≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
•Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:

Exclusion Criteria

•Myopia greater than -6.00 D. spherical equivalent in either eye.
•Known skin reactions to patch or bandage adhesives.
•Any other condition which could be a potential cause for reduced BCVA according to the investigator.
•Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded.
•History of low adherence with amblyopia treatment as assessed informally by the investigator.
•Subjects that do not wear their spectacles. (as assessed by investigator)
•History of light-induced seizures.
•Wearing RGP contact lenses.
•Any reported anatomic ocular anomaly (e.g., small lens opacity, myelinated nerve fiber layer).
•Previous intraocular or refractive surgery.