Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-02-20 @ 11:27 AM
Study NCT ID:
NCT00537992
Status:
COMPLETED
Last Update Posted:
2007-10-02
First Post:
2007-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blue-Blocking IOLs in Combined Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}, {'id': 'D012167', 'term': 'Retinal Perforations'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-01', 'studyFirstSubmitDate': '2007-10-01', 'studyFirstSubmitQcDate': '2007-10-01', 'lastUpdatePostDateStruct': {'date': '2007-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative conditions for the surgeon (scaled questionnaire) and patients´ outcome'}], 'secondaryOutcomes': [{'measure': 'complication rates and vitreoretinal diagnoses'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['combined surgery,', 'cataract surgery,', 'vitrectomy,', 'blue light-filter iols'], 'conditions': ['Epiretinal Membranes', 'Macular Holes', 'Cataract']}, 'referencesModule': {'references': [{'pmid': '16597662', 'type': 'BACKGROUND', 'citation': 'Hayashi K, Hayashi H. Visual function in patients with yellow tinted intraocular lenses compared with vision in patients with non-tinted intraocular lenses. Br J Ophthalmol. 2006 Aug;90(8):1019-23. doi: 10.1136/bjo.2006.090712. Epub 2006 Apr 5.'}, {'pmid': '16023990', 'type': 'BACKGROUND', 'citation': 'Olson RJ, Werner L, Mamalis N, Cionni R. New intraocular lens technology. Am J Ophthalmol. 2005 Oct;140(4):709-16. doi: 10.1016/j.ajo.2005.03.061. Epub 2005 Jul 18.'}, {'pmid': '18191090', 'type': 'DERIVED', 'citation': 'Falkner-Radler CI, Benesch T, Binder S. Blue light-filter intraocular lenses in vitrectomy combined with cataract surgery: results of a randomized controlled clinical trial. Am J Ophthalmol. 2008 Mar;145(3):499-503. doi: 10.1016/j.ajo.2007.10.021. Epub 2008 Jan 11.'}]}, 'descriptionModule': {'briefSummary': "Although commonly used in cataract surgery, the use of the blue light-filter IOLs in vitrectomy combined with cataract surgery has not been reported yet. A prospective controlled clinical trial was designed to evaluate the effect of the blue light-filter IOL on the surgeon's ability to perform specific vitreoretinal procedures and on the patients' outcome.", 'detailedDescription': 'Sixty patients were randomly assigned to receive a UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure.\n\nOutcome measures were intraoperative conditions for the surgeon, complication rates, the functional outcome and vitreoretinal diagnoses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis vitreoretinal pathology (diabetic vitreous hemorrhage, macular hole, epiretinal membrane or persisting macula edema)\n* Coexisting significant cataract\n* The need for combined surgery ( pars plana vitrectomy, phacoemulsification and IOL implantation)\n* Age over 50 years.\n\nExclusion Criteria:\n\n* Pseudophakia on the non-study eye\n* The need for silicone oil tamponade\n* Optic atrophy.'}, 'identificationModule': {'nctId': 'NCT00537992', 'briefTitle': 'Blue-Blocking IOLs in Combined Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery'}, 'officialTitle': 'Blue Light-Filter IOLs in Vitrectomy Combined With Cataract Surgery: Results of a Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'FR-CI-03-2007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'combined surgery', 'type': 'PROCEDURE', 'description': 'UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Susanne Binder, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery'}, {'name': 'Christiane I Falkner-Radler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery', 'class': 'OTHER'}}}}