Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2026-01-01 @ 4:33 PM
Study NCT ID:
NCT01554761
Status:
UNKNOWN
Last Update Posted:
2012-03-15
First Post:
2012-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D002386', 'term': 'Cataract'}, {'id': 'D019591', 'term': 'Pseudophakia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018918', 'term': 'Phacoemulsification'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'lastUpdateSubmitDate': '2012-03-13', 'studyFirstSubmitDate': '2012-02-27', 'studyFirstSubmitQcDate': '2012-03-13', 'lastUpdatePostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pentacam-derived corneal astigmatism', 'timeFrame': '3month postoperatively'}, {'measure': 'refraction', 'timeFrame': '3month postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['astigmatism', 'pseudophakia'], 'conditions': ['Astigmatism', 'Cataract']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the necessity of considering posterior corneal toricity on refractive outcome of patients with cataracts and corneal astigmatism after implantation of intraocular lenses.\n\nThis is determined by comparing total corneal and refractive astigmatism,and by comparing the expected refractive result with actual refractive astigmatism postoperatively,using total corneal and anterior corneal astigmatism to calculate respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cataract candidates\n* preoperative corneal regular astigmatism \\>0.75D\n* Willing and able to complete all required postoperative visits\n* Able to comprehend and sign a statement of informed consent\n\nExclusion Criteria:\n\n* significant intraocular lenses tilt or decentration\n* corneal scarring\n* Irregular corneal astigmatism\n* other ocular diseases\n* surgical complication'}, 'identificationModule': {'nctId': 'NCT01554761', 'briefTitle': 'Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University, China'}, 'officialTitle': 'Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia', 'orgStudyIdInfo': {'id': '2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'phacoemulsification', 'type': 'PROCEDURE', 'description': 'After topical anesthesia with Alcaine, 3.0-mm clear corneal incisions were made. Torsional phacoemulsification was performed using the Infiniti Vision System with the OZil handpiece, a 45-degree Kelman miniflared tip, and DuoVisc viscoelastic (all from Alcon).'}, {'name': 'Pentacam (Oculus,Germany)examination', 'type': 'DEVICE', 'description': 'Total corneal astigmatism is obtained by Pentacam at every visit.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110005', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinsong Zhang, MD', 'role': 'CONTACT', 'phone': '+86 13066667486'}, {'name': 'Qi Sun, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cheng Peng, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jiangyue Zhao, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Liwei Ma, MD.PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Eye hospital of China Medical Univerisity', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Qi Sun, MD', 'role': 'CONTACT', 'email': 'qisun97@sina.com', 'phone': '+86 15840336028'}], 'overallOfficials': [{'name': 'Jinsong Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye Hospital of China Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,the President of Eye hosptial of China Medical Univerisity,China', 'investigatorFullName': 'Jinsong Zhang', 'investigatorAffiliation': 'China Medical University, China'}}}}