Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 10:07 PM
Study NCT ID:
NCT00521833
Status:
COMPLETED
Last Update Posted:
2007-09-05
First Post:
2007-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018918', 'term': 'Phacoemulsification'}, {'id': 'D019654', 'term': 'Lens Implantation, Intraocular'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-04', 'studyFirstSubmitDate': '2007-08-27', 'studyFirstSubmitQcDate': '2007-08-27', 'lastUpdatePostDateStruct': {'date': '2007-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total and Surgical Induced Astigmatism', 'timeFrame': 'At 1 and 4 weeks and 6 month after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Kataract', 'Astigmatism', 'phacoemulsification'], 'conditions': ['Surrgical Induced Astigmatism']}, 'descriptionModule': {'briefSummary': 'To compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and intraocular lens implantation using temporal versus nasal clear corneal incisions.', 'detailedDescription': 'In a clinical trial, consecutive eyes with senile cataract underwent phacoemulsification with implantation of a 6.0 mm foldable hydrophobic acrylic intraocular lens through a 3.2 mm horizontal clear cornea incision at 180 degrees (temporal incision in right eyes, nasal incision in left eyes). Keratometric astigmatism was measured preoperatively and one and four weeks and 6 months after surgery. Surgically induced astigmatism (SIA) was calculated by the vector analysis method using the Holladay-Cravy-Koch formula. Patients with history of diabetes mellitus, connective tissue disorders, steroid use, previous ocular surgery, with the rule astigmatism \\>1D, pseudoexfoliation and any corneal pathology were excluded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients with senile cataract\n\nExclusion Criteria:\n\n* Previously operated eyes\n* Presence of corneal pathology\n* Pseudo exfoliation\n* With-the-rule (WTR) astigmatism \\>1 D\n* Presence of diabetes mellitus\n* History of connective tissue disease\n* Consumption of systemic steroids'}, 'identificationModule': {'nctId': 'NCT00521833', 'briefTitle': 'Surgically Induced Astigmatism of Temporal Versus Nasal Clear Corneal Phacoemulsification', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '8380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Temporal (right eye)', 'interventionNames': ['Procedure: phacoemulsification and intraocular lens implantation']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Nasal (Left eye)', 'interventionNames': ['Procedure: phacoemulsification and intraocular lens implantation']}], 'interventions': [{'name': 'phacoemulsification and intraocular lens implantation', 'type': 'PROCEDURE', 'description': 'clear cornea phacoemulsification and intraocular lens implantation using temporal or nasal incisions respectively', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16666', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Ophthalmic research center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Mohammad Pakravan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}}}}