CURESIGHT BINOCULAR AMBLYOPIA TREATMENT STUDY

NCT04785690 | Completed FDA Device

• 1 other identifier: NS-00706-R01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

• best corrected visual acuity

  mean change in amblyopic eye distance BCVA

  16 weeks

Study Arms (2)

CureSight

EXPERIMENTAL

eye-tracking-based

Device: CureSight

Patching

ACTIVE COMPARATOR

occlusive deprivation

Device: Patching

Interventions

CureSight DEVICE

Subjects assigned to the binocular treatment group will be prescribed the CureSight treatment to watch for 90 minutes per day, 5 days a week for 16 weeks for the total of 120 hours. Parents of subjects will be instructed that the 90 minutes of daily treatment should be completed in a single 90-minute session, but if this is not possible for whatever reason, the treatment may be divided into two shorter sessions totaling 90 minutes per day

CureSight

Patching DEVICE

Subjects assigned to the patching group will wear an adhesive patch over the dominant eye for 2 hours per day, 7 days per week for 16 weeks. Parents of subjects will be instructed that the 2 hours of daily patching should be completed in a single 2-hour session, but if this is not possible for whatever reason, the treatment may be divided into shorter sessions totaling 2 hours. Parents will be asked to complete a usage diary by manually recording the patch usage time on daily basis.

Patching

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Criteria for strabismus are met (see above)
• ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
• Amblyopia associated with anisometropia, strabismus or both meeting at least one of the following conditions:
• Newly diagnosed amblyopia (i.e. no prior treatment)
• Non-adherence to amblyopia treatment with no treatment administered for a minimum of 8 weeks prior to the Screening Visit

You may not qualify if:

• 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.
• Any condition that prevents the subject from completing a continues 45-90 min. of treatment per day while seating in front of a near screen. Such as children who don't like or cannot watch TV/movies for more than 60 min every day according to the parent's report.
• Heterophoria with a total near deviation of ≥10Δ (measured by PACT).

Sponsors & Collaborators

• NovaSight: lead

Study Sites (1)

Virginia Pediatric Eye Center

Virginia Beach, Virginia, 23452, United States

Location

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Crouch, MD

  Virginia Pediatric Eye Center 4665 South Blvd. Virginia Beach, VA 23452

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Subjects will be seen at follow-up visits. A Masked Examiner must complete distance VA, near VA and stereoacuity testing at these visits. All procedures will be performed with the subject's current spectacle correction. If a subject currently wears spectacles but is not wearing them at the follow-up examination for whatever reason, testing must be performed in trial frames except for Visit 1 and Visit 5 visual acuity must ONLY be performed in current refractive correction glasses (not trial frames). Prior to the Masked Examiner entering the room, subjects and parents should be instructed not to discuss their treatment with the Masked Examiner.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Post-Marketing Study: Yes

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: March 31, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)