Treatment for Amblyopia Under Binocular Conditions Versus the Standard of Care, Monocular Deprivation Treatment

NCT ID: NCT05185076

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-17
• Study Completion Date: 2022-05-31

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:

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)

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:

Assist first time setup at home over the phone Provide technical support by phone in case of system malfunction or any other query or problem appearing during treatment Respond to compliance notifications of the software and contact the subject's guardians when needed in order to encourage compliance 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.

Conditions

Amblyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CureSight eye-tracking-based

Device: CureSight 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

Group Type: EXPERIMENTAL

CureSight

Intervention Type: DEVICE

watch CureSight treatment for 90 minutes per day, 5 days a week for 16 weeks

Patching occlusive deprivation

Device: Patching 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.

Group Type: ACTIVE_COMPARATOR

CureSight

Intervention Type: DEVICE

watch CureSight treatment for 90 minutes per day, 5 days a week for 16 weeks

Interventions

CureSight

watch CureSight treatment for 90 minutes per day, 5 days a week for 16 weeks

Intervention Type: DEVICE

Other Intervention Names

Patching ,occlusive deprivation

Eligibility Criteria

Inclusion Criteria

8. 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).

9. Signed and dated informed consent form.

10. Parent and participant understand and are willing to comply with study procedures and will be available for the duration of the study.

Exclusion Criteria

A subject is excluded for any of the following reasons:

1. Myopia greater than -6.00 D. spherical equivalent in either eye.

2. Known skin reactions to patch or bandage adhesives.

3. Any other condition which could be a potential cause for reduced BCVA according to the investigator.

4. 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.

5. History of low adherence with amblyopia treatment as assessed informally by the investigator.

6. Subjects that do not wear their spectacles. (as assessed by investigator)

7. History of light-induced seizures.

8. Wearing RGP contact lenses.

9. Any reported anatomic ocular anomaly (e.g., small lens opacity, myelinated nerve fiber layer).

10. Previous intraocular or refractive surgery.

11. 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.

12. Heterophoria with a total near deviation of ≥10Δ (measured by PACT).

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NovaSight

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abraham Spierer, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Locations

Rambam medical center

Haifa, , Israel

Haim Sheba medical center

Ramat Gan, , Israel

Countries

Israel

References

Wygnanski-Jaffe T, Moshkovitz A, Kushner BJ, Belkin M, Yehezkel O; CureSight Pivotal Trial Group. Binocular Home Treatment for Amblyopia: Gains Stable for One Year. Am J Ophthalmol. 2024 Jun;262:199-205. doi: 10.1016/j.ajo.2024.02.004. Epub 2024 Feb 14.

Reference Type: DERIVED

PMID: 38360334 (View on PubMed)

Other Identifiers

NS-00551

Identifier Type: -

Identifier Source: org_study_id