CURESIGHT BINOCULAR AMBLYOPIA TREATMENT STUDY
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional

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. 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
    

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.
    

Intervention name(s): CureSight; Patching
Intervention type(s): Device; Device
Intervention description(s): 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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Care Provider)
Primary purpose: Treatment