Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05078099 |
| Other study ID # |
NS-00101-R01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 5, 2018 |
| Est. completion date |
March 19, 2020 |
Study information
| Verified date |
September 2021 |
| Source |
NovaSight |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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
- Visit 1: 4 weeks ± 1 week
- Visit 2: 8 weeks ± 1 week
- Visit 3: 12 weeks ± 1 week
- Visit 4: 24 weeks ± 1 week (primary endpoint)
- Optional Visit 5: 52 weeks ± 1 week (exploratory outcome, including retainment of
improvement; and additional exploratory outcomes)
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
- Visit 1: 4 weeks ± 1 week
- Visit 2: 8 weeks ± 1 week
- Visit 3: 12 weeks ± 1 week
- Optional Visit 5: 52 weeks ± 1 week (exploratory outcome, including retainment of
improvement; and additional exploratory outcomes)
- For each individual subject, clinician's decision regarding: continue treatment by
patching or terminate treatment Treatment cessation and follow-up; or, Treatment
continuation (patching)
- Visit 4: 24 weeks ± 1 week (primary endpoint)
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.
