Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-31 @ 7:34 PM
Study NCT ID:
NCT06049459
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2023-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Amblyopia Treatment With Virtual Reality Games
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000550', 'term': 'Amblyopia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessor will be masked to past performance and adherence.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a within-subject study, and all participants complete both study conditions. Each participant completes 16 weeks of optical correction alone (if needed) followed by 16 weeks of Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction. Each subject serves as their own control.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2023-09-15', 'studyFirstSubmitQcDate': '2023-09-15', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Mean Change in Amblyopic Eye Visual Acuity', 'timeFrame': 'Baseline to 16 weeks versus 16 weeks to 32 weeks', 'description': 'Optical correction worn for testing using Amblyopia Treatment Study (ATS) protocol; HOTV for ages 5-6 years; E-ETDRS for ages 7 years and older'}], 'secondaryOutcomes': [{'measure': 'Difference in Change in Stereoacuity/Binocularity', 'timeFrame': 'Baseline to 16 weeks versus 16 weeks to 32 weeks', 'description': 'Optical correction worn for testing. Stereoacuity scores (seconds of arc) calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) tests. Lower scores indicate better stereoacuity. Nil (4000) defined as an incorrect response (or lack of an attempt) on the butterfly without a correct response on 800 seconds of arc level of Randot Preschool stereoacuity test. Stereoacuity scores will be ordered and assigned a rank score. Change in stereoacuity will be calculated as the difference in change in ranked score.'}, {'measure': 'Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity', 'timeFrame': 'Baseline to 16 weeks versus 16 weeks to 32 weeks', 'description': 'Optical correction worn for testing. Spot Checks;Contrast sensitivity scores range from unable (\\<0.90), and then from 0.90 to 2.05 (by 0.05 log contrast sensitivity units).'}, {'measure': 'Difference in Mean Change in Attention', 'timeFrame': 'Baseline to 16 weeks versus 16 weeks to 32 weeks', 'description': "Optical correction worn for testing. The Children's Color Trails Test (CCTT) is a neuropsychological standardized test that measures attention, divided attention, and speed of mental processing."}, {'measure': 'Difference in Mean Change in reading eye movements', 'timeFrame': 'Baseline to 16 weeks versus 16 weeks to 32 weeks', 'description': 'Optical correction worn for testing with Readalyzer eye tracker.'}, {'measure': 'Difference in Mean Change in visual-motor integration', 'timeFrame': 'Baseline to 16 weeks versus 16 weeks to 32 weeks', 'description': 'Optical correction worn for testing. Beery Visual-Motor Integration; standard scores with mean of 100, standard deviation of 15'}, {'measure': 'Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)', 'timeFrame': 'Baseline to 16 weeks versus 16 weeks to 32 weeks', 'description': 'Pediatric Eye Questionnaire (PedEyeQ) domain score; scores for questionnaire items will be obtained from published look-up tables available at www.pedig.net; scaled to score from 0 to 100 (worst to best)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Amblyopia']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is:\n\nIs a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone?\n\nParticipants will each serve as their own control and complete:\n\nTreatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients ages 5 to 17 years of age\n\n* Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd\n* Age normal VA in the nonamblyopic eye\n* Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (\\<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)\n* Interocular difference of ≥ 3 lines\n* No amblyopia treatment in the past 2 weeks\n* An interpupillary distance of 52-72 mm (inclusive)\n\nExclusion Criteria:\n\n* Myopia greater than -6.00 diopters (D) spherical equivalent in either eye.\n* Previous intraocular or refractive surgery.\n* Previous dichoptic treatment \\> 2 weeks in duration\n* Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met).\n* Diplopia more than once per week over the last week prior to enrollment by parental report.\n* Down syndrome or cerebral palsy.\n* Light-induced seizures\n* Known simulator sickness\n* Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.'}, 'identificationModule': {'nctId': 'NCT06049459', 'briefTitle': 'Novel Amblyopia Treatment With Virtual Reality Games', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games', 'orgStudyIdInfo': {'id': '2023H0013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Optical Correction alone', 'description': 'Optical correction alone (16 weeks) (Each participant will complete both study conditions.)', 'interventionNames': ['Device: Optical Correction']}, {'type': 'EXPERIMENTAL', 'label': 'Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction', 'description': 'Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.)', 'interventionNames': ['Device: Optical Correction', 'Device: Therapeutic Dichoptic Virtual Reality Games']}], 'interventions': [{'name': 'Optical Correction', 'type': 'DEVICE', 'description': 'Optical correction (if needed)', 'armGroupLabels': ['Optical Correction alone', 'Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction']}, {'name': 'Therapeutic Dichoptic Virtual Reality Games', 'type': 'DEVICE', 'description': 'Virtual Reality Game play for amblyopia treatment', 'armGroupLabels': ['Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marjean T Kulp, OD, MS', 'role': 'CONTACT', 'email': 'kulp.6@osu.edu', 'phone': '614-688-3336'}], 'facility': 'The Ohio State University College of Optometry', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Marjean T Kulp, OD, MS', 'role': 'CONTACT', 'email': 'kulp.6@osu.edu', 'phone': '614-688-3336'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marjean Kulp', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beta Sigma Kappa - College of Optometrists in Vision Development', 'class': 'UNKNOWN'}, {'name': 'VividVision', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marjean Kulp', 'investigatorAffiliation': 'Ohio State University'}}}}