Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT01396616
Status:
UNKNOWN
Last Update Posted:
2013-01-08
First Post:
2011-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Toric Intraocular Lens Made by Aurolab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-08-13', 'releaseDate': '2014-07-24'}], 'estimatedResultsFirstSubmitDate': '2014-07-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-07', 'studyFirstSubmitDate': '2011-07-14', 'studyFirstSubmitQcDate': '2011-07-17', 'lastUpdatePostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vision improvement', 'timeFrame': '150 days', 'description': 'The visual acuity will be measured after iol implantation on 1 day, 10 days, 40 days and 150 days post operatively'}], 'secondaryOutcomes': [{'measure': 'Refractive error correction', 'timeFrame': '150 days', 'description': 'To measure the refraction error after IOL implantation on 1 day, 10 days, 40 days and 150 days post operatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational stability after implantation of TORIC IOL and to assess the post operative complications after implantation of TORIC IOL.', 'detailedDescription': 'Among available methods for treating astigmatism in cataract surgery, the implantation of toric IOLs is an emerging technology that shows promising results. Similar to implanting a one-piece acrylic lens, toric IOLs provide good distance vision and, in many patients, freedom from spectacles for distance vision. A low absolute residual refractive cylinder has been associated with the implantation of toric IOLs, and the safety profile for toric IOLs has been good. As improvements with regard to rotational stability and treatment and cylinder power range are made, toric IOLs will emerge as an effective, safe treatment option for correcting astigmatism during cataract surgery.\n\nFurther, to evidence on the safety and efficacy of TORIC IOL for patients having cataract associated with astigmatism served as the basis for us to identify the published literature on the safety and efficacy of TORIC IOL implantation in the treatment of cataract associated with astigmatism, thus provide a background for the development of clinical investigation plan for the present study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40 to 65\n* Senile cataract\n* Posterior Sub Capsular Cataract (PSCC)\n* Astigmatism 1.25 D or more\n* Residence within 100 kms of Madurai\n\nExclusion Criteria:\n\n* Traumatic \\& Complicated cataract\n* Poor mydriasis\n* Amblyopia\n* Severe Pseudo exfoliation (PXF)\n* Dense posterior polar cataract (PPC)\n* One eyed patients\n* Uveitis\n* Corneal pathology / Scar\n* Retinal Pathology contributing to visual loss\n* Intraoperative complication like PC rupture, Zonular dialysis'}, 'identificationModule': {'nctId': 'NCT01396616', 'acronym': 'TORICIOL', 'briefTitle': 'Clinical Evaluation of Toric Intraocular Lens Made by Aurolab', 'organization': {'class': 'OTHER', 'fullName': 'Aurolab'}, 'officialTitle': 'Clinical Evaluation of Toric Intraocular Lens Made by Aurolab', 'orgStudyIdInfo': {'id': '1PN1011037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'description': 'The enrolled subject will be implanted with Toric IOL manufactured by AuroLab', 'interventionNames': ['Device: Experimental - Toric Intraocular lenses']}], 'interventions': [{'name': 'Experimental - Toric Intraocular lenses', 'type': 'DEVICE', 'description': 'Toric Intraocular Lenses will be implenated with cataract patients having astigmatism', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625020', 'city': 'Madurai', 'state': 'Tamil Nadu', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr. Haripriya Aravind, MBBS., MS', 'role': 'CONTACT', 'email': 'drharipriya@aravind.org', 'phone': '+91 452 4356100', 'phoneExt': '161'}, {'name': 'Mrs. Kamatchi Kannan, BA', 'role': 'CONTACT', 'email': 'clinicaltrials@aravind.org', 'phone': '+91 452 4356100', 'phoneExt': '364'}], 'facility': 'Aravind Eye Hospital', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}], 'centralContacts': [{'name': 'Dr. Haripriya Aravind, MBBS., MS.,', 'role': 'CONTACT', 'email': 'haripriya@aravind.org', 'phone': '+91 452 4356100', 'phoneExt': '161'}, {'name': 'Mr. Mohamed Hussain, M.Pharm', 'role': 'CONTACT', 'email': 'clinicalresearch@aravind.org', 'phone': '+91 452 4356100', 'phoneExt': '364'}], 'overallOfficials': [{'name': 'Dr. SHIVKUMAR CHANDRASHEKAR, MBBS., MS.,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOD of IOL & Cataract clinic, Aravind Eye Hospital, Tirunelveli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aurolab', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-07-24', 'type': 'RELEASE'}, {'date': '2014-08-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Aurolab'}}}}