Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-27 @ 10:53 PM
Study NCT ID:
NCT01166503
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2010-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Versus Delayed Surgery for Infantile Esotropia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004948', 'term': 'Esotropia'}], 'ancestors': [{'id': 'D013285', 'term': 'Strabismus'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2010-07-19', 'studyFirstSubmitQcDate': '2010-07-19', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motion visual evoked potential (mVEPs) asymmetry', 'timeFrame': 'at age 2 years', 'description': 'mVEP measures the perception of nasalward and temporalward motion for each eye at the cortical level. A nasal bias index (NBI) is calculated, which will show whether subjects perceive motion better for one direction over the other.'}, {'measure': 'Stereopsis', 'timeFrame': 'at 2 and 5 years of age', 'description': 'This measures the level of 3D depth perception.'}, {'measure': 'Optokinetic nystagmus (OKN) asymmetry', 'timeFrame': 'at age 5 years', 'description': 'OKN is measured in both the nasalward and temporalward directions for each eye. From this a nasal bias index (NBI) is calculated, which will show whether subjects perceive motion better in one direction or the other.'}, {'measure': 'Global Motion Perception', 'timeFrame': 'at 2 and 5 years of age', 'description': 'Motion perception will be tested using two tasks: motion detection (at age 2 and 5 years) and motion discrimination (at age 5 years).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatrics', 'Esotropia', 'Surgery'], 'conditions': ['Esotropia']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine whether corrective surgery done earlier than the current standard can better improve the visual and eye movement deficits in children with infantile esotropia (crossed eyes in infancy).', 'detailedDescription': 'While there is a uniform agreement among pediatric ophthalmologists that most infantile esotropia requires surgical correction, the proper timing of surgery is controversial. In North America, the typical age at surgery ranges from 11-18 months. Unfortunately, despite successful surgical realignment of the eyes, the sensory and eye movement deficits often persist. Recently, some pediatric ophthalmologists have advocated earlier surgery. The rationale for early surgery stems from animal and human research showing that early realignment of the eyes within an early critical period allows normal development of the sensory and eye movement systems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with infantile esotropia will be enrolled from The Hospital for Sick Children in Toronto. Infants with characteristics that indicate low likelihood of spontaneous resolution will be studied.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. onset of esotropia after 10 weeks of age;\n2. constant esotropia ≥ 20° (40 prism diopter or PD) at near (1/3 m) on two examinations, separated by 2-4 weeks; and\n3. refractive error ≤ +3.00 diopters (far-sightedness).\n\nExclusion Criteria:\n\n1. gestational age \\< 34 weeks;\n2. birth weight ≤ 1500 g;\n3. ventilator treatment in the newborn period;\n4. history of meningitis or other major medical event;\n5. developmental delay;\n6. incomitant or paralytic strabismus;\n7. manifest nystagmus or head bobbing;\n8. prior eye muscle surgery;\n9. prior treatment of amblyopia or spectacle correction for refractive errors;\n10. presence of structural ocular anomalies.'}, 'identificationModule': {'nctId': 'NCT01166503', 'briefTitle': 'Early Versus Delayed Surgery for Infantile Esotropia', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Early Versus Delayed Surgery for Infantile Esotropia: A Clinical Evaluation of Sensory and Motor Outcomes', 'orgStudyIdInfo': {'id': '1000005134'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early Surgery', 'description': 'This group will be made up of subjects whose parents choose to have them undergo corrective surgery at or before age 11 months.', 'interventionNames': ['Procedure: mVEP Testing', 'Procedure: Stereoacuity Testing', 'Procedure: Optokinetic nystagmus testing', 'Procedure: Motion detection testing', 'Procedure: Motion discrimination testing']}, {'label': 'Standard Surgery', 'description': 'This group will be made up of subjects who present after age 11 months or whose parents choose to have them undergo corrective surgery between 11-18 months.', 'interventionNames': ['Procedure: mVEP Testing', 'Procedure: Stereoacuity Testing', 'Procedure: Optokinetic nystagmus testing', 'Procedure: Motion detection testing', 'Procedure: Motion discrimination testing']}], 'interventions': [{'name': 'mVEP Testing', 'type': 'PROCEDURE', 'description': "Five small sensors are placed on the head which record the brain's response to moving stripes that are displayed on a computer screen. Each eye is tested while the other eye is patched. Each recording trial lasts about 10 seconds, and several trials are done for each eye.", 'armGroupLabels': ['Early Surgery', 'Standard Surgery']}, {'name': 'Stereoacuity Testing', 'type': 'PROCEDURE', 'description': 'Subjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus).', 'armGroupLabels': ['Early Surgery', 'Standard Surgery']}, {'name': 'Optokinetic nystagmus testing', 'type': 'PROCEDURE', 'description': 'Subjects will be asked to view a screen with vertical stripes moving in both leftward and rightward directions while their eye movements are recorded using a remote video-based eye tracker.', 'armGroupLabels': ['Early Surgery', 'Standard Surgery']}, {'name': 'Motion detection testing', 'type': 'PROCEDURE', 'description': 'Subjects will view a computer screen that has two panels of dots on them. The subject will be required to pick which panel has a section of dots that are moving in a specific direction (ie. nasalward/temporalward).', 'armGroupLabels': ['Early Surgery', 'Standard Surgery']}, {'name': 'Motion discrimination testing', 'type': 'PROCEDURE', 'description': 'Subjects will view a computer screen that has two panels of randomly moving dots on them. The subject will be required to pick which panel has a section of dots that are moving in a specific direction (ie. nasalward/temporalward).', 'armGroupLabels': ['Early Surgery', 'Standard Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Agnes Wong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children, Toronto Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophthamologist-In-Chief', 'investigatorFullName': 'Agnes Wong', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}