Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-10 @ 9:40 AM
Study NCT ID:
NCT04429659
Status:
COMPLETED
Last Update Posted:
2020-06-12
First Post:
2020-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D004948', 'term': 'Esotropia'}, {'id': 'D000550', 'term': 'Amblyopia'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D013285', 'term': 'Strabismus'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2020-06-09', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'spherical equivalent', 'timeFrame': '36 months', 'description': 'spherical error plus half of the cylindirical error measured by retinoscopy, diopter'}, {'measure': 'cylindirical error', 'timeFrame': '36 months', 'description': 'cylindirical error measured by retinoscopy, diopter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractive Errors', 'Esotropia', 'Amblyopia Strabismic']}, 'descriptionModule': {'briefSummary': 'To investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative esotropia (RAET) were included in the study as a control group. Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the control groups.', 'detailedDescription': 'Purpose: To investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).\n\nMaterial-Method: Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative esotropia (RAET) were included in the study as a control group. Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the control groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'study population was composed of amblyopic children with partially refractive ET.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\namblyopic children with partially refractive accommodative esotropia as study group non- amblyopic children with fully refractive accommodative esotropia as control group\n\n\\-\n\nExclusion Criteria:\n\nSystemic diseases Neurological disorders and diseases Additional ocular diseases'}, 'identificationModule': {'nctId': 'NCT04429659', 'briefTitle': 'Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia', 'organization': {'class': 'OTHER', 'fullName': 'Sakarya University'}, 'officialTitle': 'Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia', 'orgStudyIdInfo': {'id': 'Sakarya strabismus'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1, patients with amblyopia and partially refractive ET', 'description': 'children with both amblyopia and partially refractive accommodative esotropia'}, {'label': 'Group 2, patients with refractive ET', 'description': 'children with refractive esotropia'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sakarya', 'country': 'Turkey (Türkiye)', 'facility': 'Sakarya University Ophthalmology Department', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}], 'overallOfficials': [{'name': 'Burcin Cakir, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sakarya University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sakarya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}