Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-27 @ 3:41 AM
Study NCT ID:
NCT00801359
Status:
COMPLETED
Last Update Posted:
2008-12-16
First Post:
2008-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BSSPlus Versus Lactated Ringer's for Phacoemulsification
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': 'D018918', 'term': 'Phacoemulsification'}, {'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-15', 'studyFirstSubmitDate': '2008-12-02', 'studyFirstSubmitQcDate': '2008-12-02', 'lastUpdatePostDateStruct': {'date': '2008-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endothelial cell density', 'timeFrame': 'baseline and at 1, 8, 15, 30 and 60 days postoperatively'}, {'measure': 'central corneal thickness', 'timeFrame': 'baseline and at 1, 8, 15, 30 and 60 days postoperatively'}], 'secondaryOutcomes': [{'measure': 'number of anterior chamber cells and flare grade', 'timeFrame': 'baseline and at 1, 8, 15, 30 and 60 days postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cataract', 'phacoemulsification', 'irrigation solution', 'endothelial cell density', 'corneal thickness'], 'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '7862416', 'type': 'BACKGROUND', 'citation': "Puckett TR, Peele KA, Howard RS, Kramer KK. Intraocular irrigating solutions. A randomized clinical trial of balanced salt solution plus and dextrose bicarbonate lactated Ringer's solution. Ophthalmology. 1995 Feb;102(2):291-6. doi: 10.1016/s0161-6420(95)31026-3."}, {'pmid': '931689', 'type': 'BACKGROUND', 'citation': 'McCarey BE, Polack FM, Marshall W. The phacoemulsification procedure. I. The effect of intraocular irrigating solutions on the corneal endothelium. Invest Ophthalmol. 1976 Jun;15(6):449-57.'}, {'pmid': '10713235', 'type': 'BACKGROUND', 'citation': 'Joussen AM, Barth U, Cubuk H, Koch H. Effect of irrigating solution and irrigation temperature on the cornea and pupil during phacoemulsification. J Cataract Refract Surg. 2000 Mar;26(3):392-7. doi: 10.1016/s0886-3350(99)00470-8.'}, {'pmid': '5636786', 'type': 'BACKGROUND', 'citation': 'Kaye GI, Mishima S, Cole JD, Kaye NW. Studies on the cornea. VII. Effects of perfusion with a Ca++-free medium on the corneal endothelium. Invest Ophthalmol. 1968 Feb;7(1):53-66. No abstract available.'}, {'pmid': '3513079', 'type': 'BACKGROUND', 'citation': 'Rosenfeld SI, Waltman SR, Olk RJ, Gordon M. Comparison of intraocular irrigating solutions in pars plana vitrectomy. Ophthalmology. 1986 Jan;93(1):109-15. doi: 10.1016/s0161-6420(86)33790-4.'}]}, 'descriptionModule': {'briefSummary': "Two intraocular irrigating solutions (BSSPlus versus Lactated Ringer's) are compared in this prospective, randomized, masked trial to investigate for differences in preservation of corneal integrity after phacoemulsification cataract surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with senile cataract\n* Visual acuity between 20/400 and 20/40\n\nExclusion Criteria:\n\n* Presence of corneal opacity\n* Presence of corneal disease\n* Traumatic, toxic, hereditary (congenital)and complicated cataracts(uveitis)\n* Anterior chamber cells or flare detected before surgery\n* Previous ocular surgery\n* Any condition which may affect documentation or follow-up'}, 'identificationModule': {'nctId': 'NCT00801359', 'briefTitle': "BSSPlus Versus Lactated Ringer's for Phacoemulsification", 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': "Comparison of Corneal Changes After Phacoemulsification Using BSSPlus Versus Lactated Ringer's Irrigating Solution", 'orgStudyIdInfo': {'id': '8657/2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BSSplus', 'interventionNames': ['Procedure: Phacoemulsification', 'Drug: BSSPlus solution']}, {'type': 'EXPERIMENTAL', 'label': 'Ringer', 'interventionNames': ['Procedure: Phacoemulsification', "Drug: Lactated Ringer's solution"]}], 'interventions': [{'name': 'Phacoemulsification', 'type': 'PROCEDURE', 'armGroupLabels': ['BSSplus', 'Ringer']}, {'name': 'BSSPlus solution', 'type': 'DRUG', 'armGroupLabels': ['BSSplus']}, {'name': "Lactated Ringer's solution", 'type': 'DRUG', 'armGroupLabels': ['Ringer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14049-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; Centro Avançado de Retina e Catarata', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Rodrigo Jorge', 'oldOrganization': 'University of São Paulo'}}}}