Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05185076
Study type Interventional
Source NovaSight
Contact
Status Active, not recruiting
Phase N/A
Start date August 17, 2021
Completion date May 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04238065 - A Clinical Trial of Caterna Virtual Reality Facilitating Treatment in Children With Amblyopia N/A
Completed NCT04432181 - Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia
Recruiting NCT02767856 - Regimens of Intermittent Occlusion Therapy for Amblyopia in Children N/A
Completed NCT02458846 - Efficacy of Visual Screening in Ontario N/A
Completed NCT01190813 - Levodopa for the Treatment of Residual Amblyopia Phase 3
Completed NCT01109459 - Multimodal Physician Intervention to Detect Amblyopia N/A
Recruiting NCT04313257 - Monocular Action Video Game Treatment of Amblyopia N/A
Completed NCT01430247 - Vision Screening for the Detection of Amblyopia N/A
Completed NCT02200211 - Study of Binocular Computer Activities for Treatment of Amblyopia N/A
Recruiting NCT03655912 - Binocular Visual Therapy and Video Games for Amblyopia Treatment. N/A
Completed NCT03754153 - Binocularly Balanced Viewing Study N/A
Terminated NCT02246556 - Dichoptic Virtual Reality Therapy for Amblyopia in Adults Phase 1
Withdrawn NCT02594358 - Caffeine in Amblyopia Study Phase 1/Phase 2
Completed NCT02003235 - Assessment of Device for Treatment of Amblyopia N/A
Completed NCT01726842 - Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner N/A
Completed NCT01308307 - Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia? Phase 2
Terminated NCT00506675 - Combined Patching-Atropine for Residual Amblyopia Phase 3
Completed NCT00094692 - An Evaluation of Treatment of Amblyopia in Children 7 To <18 Years Old Phase 3
Withdrawn NCT03906994 - Treating Amblyopia in Adults With Interactive Video Games N/A
Completed NCT04303832 - Exercise Interventions of Eye Muscles Post Strabismus Surgery N/A