AmblyopiaNCT05078099
Eye-tracking Based Amblyopia Training
A study testing CureSight in people with Amblyopia, run by NovaSight at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 4 to 40 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- CureSight
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Dec 2018to 19 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The following criteria must be met for a child to be enrolled in the study:
- Age 4 to 40 years male and female
- Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
- Must have refractive error correction (based on a cycloplegic refraction completed within the last 7 months)
- Spectacle correction meeting the above criteria must be worn For at least 16 weeks OR until distance VA stability is documented (defined as <0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart).
- VA, measured in each eye without cycloplegia in current spectacle correction using the Lea symbol per ATS VA protocol for children < 7 years and the EETDRS VA protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows:
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- Visual acuity in the amblyopic eye <1.0 logMAR (20/200)
- Best-corrected dominant-eye VA <0.2
- Interocular difference ≥ 2 logMAR lines
- Heterotropia with a near deviation of <5∆ (measured by SPCT) in habitual correction (Angles of ocular deviation >4∆ are not allowed because large magnitudes of the deviation would compromise successful alignment of the dichoptic stimuli.)
- Passing a dedicated 10 min in-clinic performance ability test to assure suitable eye tracking performance (validity of eye tracking data >90% and successful calibration process).
- 7. Subjects and families eligible for clinic visits over duration of study.
- 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.
Who cannot join
- Myopia greater than -6.00 D. spherical equivalent in either eye.
- Known skin reactions to patch or bandage adhesives.
- Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator).
- Any condition that might interfere with eye tracking, such as ptosis
- Any reported anatomic ocular anomaly (e.g., small lens opacity, myelinated nerve fiber layer).
- Previous intraocular or refractive surgery.
- Heterophoria with a total near deviation of ≥10Δ (measured by PACT
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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)
Read the detailed 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:
- 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
- Being tested
- CureSight
- Keywords
- Amblyopia, Lazy eye, Binocular treatment, Dichoptic treatment, Eye tracking, Visual acuity, Stereoacuity, Adherence
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CureSightDevice
Binocular eye-tracking-based passive home treatment system delivering personalized amblyopia therapy
| Study group | Role | What they receive |
|---|---|---|
| Study arm - Binocular CureSight | Experimental | Using binocular treatment device 90 min a day 5 times a week for 12 weeks following by 90 min a day 3 times a week for additional 12 weeks Receives: Device: CureSight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-Corrected Visual Acuity of Amblyopic Eye
Mean visual acuity change from baseline Using LogMAR LEA symbols optotype for participants < 7 years of age and LEA numbers optotype for participants ≥ 7 years of age
Measured: 24 weeks
Best-Corrected Visual Acuity of Fellow Eye
Mean visual acuity change from baseline Using LogMAR LEA symbols for participants < 7 years of age and LEA numbers for participants ≥ 7 years of age
Measured: 24 weeks
Secondary outcomes (3)
Adherence
Duration spent using the device divided by the duration of treatment prescribed
Measured: 4, 8, 12, and 24 weeks
Stereoacuity
Mean stereoacuity change from baseline using the Titmus stereo acuity chart
Measured: 4, 8, 12, and 24 weeks
Amblyopic eye best-corrected visual acuity
Mean visual acuity change from baseline Using LogMAR LEA symbols for participants < 7 years of age and LEA numbers for participants ≥ 7 years of age
Measured: 4, 8, 12, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start5 Dec 2018
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm prospective
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaSight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tamara Wygnanski-Jaffe, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078099
- Sponsor's protocol ID
- NS-00101-R01
- Status last verified
- Sep 2021
- First submitted
- 25 Sep 2021
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data requests should be submitted to the corresponding author for consideration. Access to de-identified participant data may be made available with publication for non commercial research with a signed data access agreement
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye-tracking Based Amblyopia Training
- ClinicalTrials.gov ID
- NCT05078099
- Acronym / sponsor ID
- NS-00101-R01
- Conditions
- Amblyopia
- Keywords
- Amblyopia, Lazy eye, Binocular treatment, Dichoptic treatment, Eye tracking, Visual acuity, Stereoacuity, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NovaSightIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm prospective
| Arm | Type | Receives |
|---|---|---|
| Study arm - Binocular CureSight | Experimental | Device: CureSightUsing binocular treatment device 90 min a day 5 times a week for 12 weeks following by 90 min a day 3 times a week for additional 12 weeks |
Who may qualify
- Ages
- 4 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- Age 4 to 40 years male and female
- Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
- Must have refractive error correction (based on a cycloplegic refraction completed within the last 7 months)
- Spectacle correction meeting the above criteria must be worn For at least 16 weeks OR until distance VA stability is documented (defined as <0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart).
- VA, measured in each eye without cycloplegia in current spectacle correction using the Lea symbol per ATS VA protocol for children < 7 years and the EETDRS VA protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows:
Key exclusion criteria (7 listed)
- Myopia greater than -6.00 D. spherical equivalent in either eye.
- Known skin reactions to patch or bandage adhesives.
- Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator).
- Any condition that might interfere with eye tracking, such as ptosis
- Any reported anatomic ocular anomaly (e.g., small lens opacity, myelinated nerve fiber layer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CureSightBinocular eye-tracking-based passive home treatment system delivering personalized amblyopia therapy | Device | Study arm - Binocular CureSight |
Primary outcome
Best-Corrected Visual Acuity of Amblyopic Eye
Time frame: 24 weeks
Mean visual acuity change from baseline Using LogMAR LEA symbols optotype for participants < 7 years of age and LEA numbers optotype for participants ≥ 7 years of age
Best-Corrected Visual Acuity of Fellow Eye
Time frame: 24 weeks
Mean visual acuity change from baseline Using LogMAR LEA symbols for participants < 7 years of age and LEA numbers for participants ≥ 7 years of age
3 secondary outcomes
Adherence
Time frame: 4, 8, 12, and 24 weeks
Stereoacuity
Time frame: 4, 8, 12, and 24 weeks
Amblyopic eye best-corrected visual acuity
Time frame: 4, 8, 12, and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. All data requests should be submitted to the corresponding author for consideration. Access to de-identified participant data may be made available with publication for non commercial research with a signed data access agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Wygnanski-Jaffe, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CureSight in people with Amblyopia, run by NovaSight at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-Corrected Visual Acuity of Amblyopic Eye (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.