Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT07272005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Control of Intermittent Exotropia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in control of intermittent exotropia', 'timeFrame': '8 weeks', 'description': 'change percent time alignment is present at 8 weeks vs at baseline'}], 'secondaryOutcomes': [{'measure': 'Improvement in control of intermittent exotropia', 'timeFrame': '4 weeks', 'description': 'change percent time alignment is present at 4 weeks vs at baseline'}, {'measure': 'Improvement in control of intermittent exotropia', 'timeFrame': '12 weeks off-treatment', 'description': 'change percent time alignment is present at 12 weeks off-treatment weeks vs at baseline'}, {'measure': 'Change in suppression', 'timeFrame': '4 weeks', 'description': 'change in HATT test score at 4 weeks vs at baseline'}, {'measure': 'Change in suppression', 'timeFrame': '8 weeks', 'description': 'change in HATT test score at 8 weeks vs at baseline'}, {'measure': 'Change in suppression', 'timeFrame': '12 weeks off-treatment', 'description': 'change in HATT test score at 12 weeks off-treatment vs at baseline'}, {'measure': 'Change in distance stereoacuity', 'timeFrame': '4 weeks', 'description': 'change in Distance Randot test score at 4 weeks vs at baseline'}, {'measure': 'Change in distance stereoacuity', 'timeFrame': '8 weeks', 'description': 'change in Distance Randot test score at 8 weeks vs at baseline'}, {'measure': 'Change in distance stereoacuity', 'timeFrame': '12 weeks off-treatment', 'description': 'change in Distance Randot test score at 12 weeks off-treatment vs at baseline'}, {'measure': 'Change in quality of life', 'timeFrame': '8 weeks', 'description': 'Change in IXTQ questionnaire (Rasch-scored on a 0-100 scale) at 8 weeks vs at baseline'}, {'measure': 'Change in quality of life', 'timeFrame': '12 weeks off-treatment', 'description': 'Change in IXTQ questionnaire (Rasch-scored on a 0-100 scale) ay 12 weeks off-treatment vs at baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intermittent Exotropia']}, 'descriptionModule': {'briefSummary': 'To determine whether use of dichoptic movies for 8 weeks may be helpful in improving control alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically', 'detailedDescription': 'Intermittent exotropia (IXT) is the most common form of strabismus, characterized by an outward deviation of the eyes that is primarily manifest during distance fixation and can intermittently be controlled by fusional mechanisms. Less than 30% of children have good long-term outcomes following treatment for spontaneously manifest IXT with current non-surgical treatments (prism therapy, over-minus lenses, or vision therapy). The limited efficacy of current non-surgical treatments for IXT is thought to arise from underlying sensory deficits, particularly interocular suppression, which compromises binocular function. This underscores the need for sensory-directed interventions aimed at reducing suppression and thereby enhancing the potential for stable binocular outcomes.\n\nIn this study, children will be randomized to watch engaging videos streamed at home that are either dichoptic or standard (control) format. The aim is to determine whether the dichoptic format will decrease suppression and improve control of eye alignment . In previous research, use of dichoptic games and movies by children with amblyopia has shown to reduce suppression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of IXT or XT at Distance \\& IXT or XP at near (Basic or Pseudo Divergence Excess subtype of IXT)\n* No surgery planned for 6 months\n\nExclusion Criteria:\n\n* Prior eye muscle surgery\n* Prior binocular treatment or vision therapy\n* Amblyopia\n* Neurological conditions, seizure disorders, vestibular abnormalities, or frequent headache\n* Other eye conditions (refractive error OK)'}, 'identificationModule': {'nctId': 'NCT07272005', 'briefTitle': 'Improving Control of Intermittent Exotropia', 'organization': {'class': 'OTHER', 'fullName': 'Retina Foundation of the Southwest'}, 'officialTitle': 'Improving Control of Intermittent Exotropia', 'orgStudyIdInfo': {'id': '03 IXT2 2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Dichoptic Videos', 'description': 'dichoptic videos streamed at home 1 hour per day, 5 days per week', 'interventionNames': ['Other: dichoptic videos']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group 2: Standard Videos', 'description': 'standard videos streamed at home 1 hour per day, 5 days per week', 'interventionNames': ['Other: standard videos']}], 'interventions': [{'name': 'dichoptic videos', 'type': 'OTHER', 'description': 'custom designed dichoptic videos', 'armGroupLabels': ['Group 1: Dichoptic Videos']}, {'name': 'standard videos', 'type': 'OTHER', 'description': 'standard videos', 'armGroupLabels': ['Group 2: Standard Videos']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eileen Birch, PhD', 'role': 'CONTACT', 'email': 'ebirch@retinafoundation.org', 'phone': '2143633911'}, {'name': 'Reed Jost, MS', 'role': 'CONTACT', 'email': 'reedjost@retinafoundation.org', 'phone': '2143633911'}], 'overallOfficials': [{'name': 'Eileen E Birch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Retina Foundation of the Southwest'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Retina Foundation of the Southwest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Pediatric Vision Laboratory', 'investigatorFullName': 'Eileen Birch', 'investigatorAffiliation': 'Retina Foundation of the Southwest'}}}}