Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-06 @ 1:53 PM
Study NCT ID:
NCT01763593
Status:
UNKNOWN
Last Update Posted:
2013-04-30
First Post:
2012-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Surgical Performance Study of Aurosleek Surgical Blades
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-29', 'studyFirstSubmitDate': '2012-12-25', 'studyFirstSubmitQcDate': '2013-01-07', 'lastUpdatePostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physioclinical Characters', 'timeFrame': '30 days', 'description': 'Assessment of physio-clinical characteristics of surgical blade such as handling of the blade, sharpness and smoothness of blade.\n\nHandling of the surgical blade will be assessed in grades of difficult to handle,easy to handle and very easy to handle intraoperatively. Sharpness and smoothness of the blade will be rated as poor or optimum while performing cataract surgery.'}], 'secondaryOutcomes': [{'measure': 'Post operative complications', 'timeFrame': '30 days', 'description': 'The frequency and occurrence of post operative complications such as rhexis tear, posterior capsular rupture, severe corneal edema, severe iritis and anterior vitrectomy.\n\nPost operative complications occurrence due to surgical blade will be observed and graded as none or mild or moderate or severe at surgery and post operative 30 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients having cataract'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab.', 'detailedDescription': 'Cataract till today remains the most common yet treatable cause of blindness accounting for more than 50% of blindness and visual impairment in the developing world. One of the most important features of a blade for cataract surgery is its predictable and repeatable behavior. The surgeon repeatedly and reliably needs to create similar tunnels of the proper length. Aurolab is producing surgical blades (Aurosleek) intended for making incision in cataract surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cataract surgery would be included in this observational study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Senile cataract\n* Willing to give written informed consent\n* Ability to follow study instructions and likely to complete required visits.\n\nExclusion Criteria:\n\n* Intraoperative complication including Posterior Capsular Rent and Zonular dialysis\n* Traumatic cataract\n* Uveitis and Complicated cataract\n* One eyed patients'}, 'identificationModule': {'nctId': 'NCT01763593', 'acronym': 'Aurosleek', 'briefTitle': 'Safety and Surgical Performance Study of Aurosleek Surgical Blades', 'organization': {'class': 'OTHER', 'fullName': 'Aurolab'}, 'officialTitle': 'A Prospective, Open Label, Observational Study To Evaluate The Safety And Surgical Performance Of Surgical Blade (Aurosleek) In Cataract Patients', 'orgStudyIdInfo': {'id': 'AUROSLEEK/CIP/001/2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aurosleek blades', 'description': 'Patients having cataract will undergo surgery by using Aurosleek blades'}]}, 'contactsLocationsModule': {'locations': [{'zip': '625020', 'city': 'Madurai', 'state': 'Tamil Nadu', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Neeraj Kumar Agrawal, MS', 'role': 'CONTACT', 'email': 'agrawalneeraj84@gmail.com', 'phone': '04524356100', 'phoneExt': '181'}], 'facility': 'Aravind Eye Hospital', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}], 'centralContacts': [{'name': 'Karthikumar S, M.Pharm', 'role': 'CONTACT', 'email': 'crd@aurolab.com', 'phone': '04523096100', 'phoneExt': '228'}], 'overallOfficials': [{'name': 'Neeraj Kumar Agrawal, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Officer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aurolab', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}