Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-31 @ 8:15 AM
Study NCT ID:
NCT00449267
Status:
COMPLETED
Last Update Posted:
2009-02-11
First Post:
2007-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aurolab Hydrophobic Foldable Intraocular Lens Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007910', 'term': 'Lenses, Intraocular'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-10', 'studyFirstSubmitDate': '2007-03-17', 'studyFirstSubmitQcDate': '2007-03-19', 'lastUpdatePostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '10days, 40 days, 150 days post operatively'}], 'secondaryOutcomes': [{'measure': 'Refraction', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'Intraocular pressure', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'Corneal status', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'Iritis', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'IOL decentration', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'IOL tilt', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'IOL discoloration', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'IOL opacity', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'Cystoid macular oedema', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'Hypopyon', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'Endophthalmitis', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'Pupillary block', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'Retinal detachment', 'timeFrame': '10days, 40 days, 150 days post operatively'}, {'measure': 'Status of anterior and posterior capsule', 'timeFrame': '10days, 40 days, 150 days post operatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lenses, Intraocular', 'Prospective Studies', 'Visual acuity', 'Clinical Trial'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured by aurolab are safe and effective in the surgical treatment of cataract.', 'detailedDescription': 'Hydrophobic as the name suggests is fear for water. Hydrophobic foldable IOLs are made from acrylic material. Aurolab has developed its own hydrophobic acrylic material. This material has been subjected to several biocompatibility studies and it has proved itself to be biocompatible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40 to 65 years\n* Senile Cataract\n* Posterior Subcapsular Cataract (PSCC)\n\nExclusion Criteria:\n\n* Obviously debilitated patients\n* Cardiac and other serious illness\n* Diabetic Patients\n* Traumatic cataract\n* Complicated cataract\n* Congenital cataract\n* Drug induced cataract\n* Shallow anterior chamber\n* Poor mydriasis\n* Amblyopia\n* Pseudo exfoliation (PXF)\n* Dense posterior polar cataract (PPC)\n* One eyed patients\n* Glaucoma\n* Uveitis\n* Corneal Pathology\n* Retinal Pathology\n* Intra operative complications like PC rupture, Zonular dialysis'}, 'identificationModule': {'nctId': 'NCT00449267', 'briefTitle': 'Aurolab Hydrophobic Foldable Intraocular Lens Study', 'organization': {'class': 'OTHER', 'fullName': 'Aurolab'}, 'officialTitle': 'Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses', 'orgStudyIdInfo': {'id': '1PN1010614'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Device: Intraocular Lens']}], 'interventions': [{'name': 'Intraocular Lens', 'type': 'DEVICE', 'otherNames': ['Aurovue, Model HP757SQ'], 'description': 'Phacoemulsification with in the bag implantation of the IOL', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625020', 'city': 'Madurai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Aravind Eye Hospital', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}], 'overallOfficials': [{'name': 'Haripriya Aravind, MBBS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aravind Eye Hospital, Madurai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aurolab', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Haripriya Aravind', 'oldOrganization': 'Aravind Eye Hospital'}}}}