Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-03-04 @ 10:18 PM
Study NCT ID:
NCT00673803
Status:
COMPLETED
Last Update Posted:
2010-08-17
First Post:
2008-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Two Different Preloaded Intraocular Lens (IOLs) on Posterior Capsule Opacification
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': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-16', 'studyFirstSubmitDate': '2008-05-06', 'studyFirstSubmitQcDate': '2008-05-06', 'lastUpdatePostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCO rate', 'timeFrame': '2 years after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['posterior capsule opacification', 'micro incision', 'sharp optic edge'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'Studies showed that a sharp posterior optic edge of an intraocular lens (IOL) inhibits migration of lens epithelial cells in between posterior capsule and optic of the IOL and therefore reduces the rate of posterior capsule opacification (PCO). In present time most IOLs implanted have a sharp posterior optic edge. Due to differences in IOL production different IOLs have different rates of PCO.\n\nProgression in cataract surgery technique allow phacoemulsification through micro-incisions. Therefore there is need for IOLs that can be implanted through incisions of about 2.5 mm.\n\nThis study investigates the effect of two different hydrophobic acrylic IOLs with a sharp posterior optic edge on the rate of PCO after implantation through a micro-incision. The results will be compared intraindividually.', 'detailedDescription': 'prospective, randomized, bilateral study with intraindividual comparison, implantation of a Polylens Y10 IOL in one eye and implantation of a Polylens Y30 in the contralateral eye.\n\nPCO rate will be detected at 1 year and 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bilateral age-related cataract\n* age 55 to 80 years\n* expected postoperative visual acuity of at least 0.5\n\nExclusion Criteria:\n\n* amblyopia\n* corneal scars\n* diabetes\n* pseudoexfoliation-syndrome\n* earlier ocular surgeries or laser treatments\n* intraocular tumors'}, 'identificationModule': {'nctId': 'NCT00673803', 'briefTitle': 'Influence of Two Different Preloaded Intraocular Lens (IOLs) on Posterior Capsule Opacification', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Hietzing'}, 'officialTitle': 'Influence of Two Sharp-edged Hydrophobic Acrylic Micro-incision-IOLs on Posterior Capsule Opacification. A Randomized, Double-masked Study With Intraindividual Comparison.', 'orgStudyIdInfo': {'id': 'preloaded 2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'description': 'cataract surgery, implantation of a Polylens Y10', 'interventionNames': ['Procedure: cataract surgery']}, {'type': 'OTHER', 'label': 'B', 'description': 'cataract surgery, implantation of a Polylens Y30', 'interventionNames': ['Procedure: cataract surgery']}], 'interventions': [{'name': 'cataract surgery', 'type': 'PROCEDURE', 'otherNames': ['Polylens Y30 IOL, Polytech, Germany', 'Polylens Y10 IOL, Polytech, Germany'], 'description': 'cataract surgery with implantation of an IOL', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Department of Ophthalmology, Hietzing Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Nadja Karnik, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Hietzing', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Matthias Wirtitsch MD', 'oldOrganization': 'Hietzing Hospital, Vienna, Austria'}}}}