Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01334658
Status:
COMPLETED
Last Update Posted:
2011-04-13
First Post:
2011-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Corneas Undergoing Balanced Salt Solution(BSS ®) Versus Glucose-bicarbonate-Ringer Lactate in Cataract Surgery
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-12', 'studyFirstSubmitDate': '2011-04-08', 'studyFirstSubmitQcDate': '2011-04-12', 'lastUpdatePostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in central corneal thickness (CCT)', 'timeFrame': 'Two days after surgery.'}, {'measure': 'Increase in central corneal thickness (CCT)', 'timeFrame': 'Thirty days after surgery.'}, {'measure': 'Increase in central corneal thickness (CCT)', 'timeFrame': 'Ninety days after surgery.'}, {'measure': 'Decrease in the percentage of endothelial cell density (ECD)', 'timeFrame': 'Two days after surgery.'}, {'measure': 'Decrease in the percentage of endothelial cell density (ECD)', 'timeFrame': 'Thirty days after surgery.'}, {'measure': 'Decrease in the percentage of endothelial cell density (ECD)', 'timeFrame': 'Ninety days after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Corneal endothelium', 'Cataract surgery', 'Irrigation solutions intraocular', 'Phacoemulsification'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'This is a study aimed at evaluating the effectiveness and impact of two intraocular irrigating solution (BSS ® versus glucose-bicarbonate-Ringer Lactate - GBRL) on the health of the cornea after cataract surgery by phacoemulsification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uncomplicated senile cataract\n* Visual acuity (VA) between 20/40 and 20/400\n* Healthy corneas\n\nExclusion Criteria:\n\n* Mental incapacity\n* Patients with coexisting diseases of the cornea\n* Presence of corneal opacity\n* Uncontrolled glaucoma\n* Uncontrolled diabetes mellitus\n* Uveitis\n* Cells or flare in the anterior chamber\n* Prior intraocular surgery\n* Patients using topical steroids or systemic\n* Traumatic cataract, hereditary or toxic'}, 'identificationModule': {'nctId': 'NCT01334658', 'briefTitle': 'Study of Corneas Undergoing Balanced Salt Solution(BSS ®) Versus Glucose-bicarbonate-Ringer Lactate in Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Grupo de Estudos em Oftalmologia Clínica e Cirúrgica'}, 'officialTitle': 'Study of Endothelial Cell Density of Corneas Undergoing Phacoemulsification Surgery Using Balanced Salt Solution (BSS ®) Versus Glucose-bicarbonate-Ringer Lactate as Irrigating Solution: a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Balanced Salt Solution (BSS®)', 'description': 'Subjects who received Balanced Salt Solution.', 'interventionNames': ['Procedure: Phacoemulsification cataract surgery', 'Drug: Balanced Salt Solution (BSS®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucose-bicarbonate-Ringer Lactate (GBRL)', 'description': 'Subjects who received glucose-bicarbonate-Ringer Lactate.', 'interventionNames': ['Procedure: Phacoemulsification cataract surgery', 'Drug: Glucose-bicarbonate-Ringer Lactate (GBRL)']}], 'interventions': [{'name': 'Phacoemulsification cataract surgery', 'type': 'PROCEDURE', 'description': 'A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) \\[500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)\\] as a solution for irrigation during surgery.\n\nAll surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation \\[BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)\\] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..).', 'armGroupLabels': ['Balanced Salt Solution (BSS®)', 'Glucose-bicarbonate-Ringer Lactate (GBRL)']}, {'name': 'Glucose-bicarbonate-Ringer Lactate (GBRL)', 'type': 'DRUG', 'description': 'A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) \\[500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)\\] as a solution for irrigation during surgery.\n\nAll surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation \\[BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)\\] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..).', 'armGroupLabels': ['Glucose-bicarbonate-Ringer Lactate (GBRL)']}, {'name': 'Balanced Salt Solution (BSS®)', 'type': 'DRUG', 'description': 'A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) \\[500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)\\] as a solution for irrigation during surgery.\n\nAll surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation \\[BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)\\] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..).', 'armGroupLabels': ['Balanced Salt Solution (BSS®)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hermelino L Oliveira Neto', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CLIHON'}, {'name': 'Israel C Marques Neto', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of Feira de Santana (UEFS)'}, {'name': 'Brunno B Barros', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of Feira de Santana (UEFS)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo de Estudos em Oftalmologia Clínica e Cirúrgica', 'class': 'OTHER'}, 'collaborators': [{'name': 'CLIHON', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Hermelino Lopes de Oliveira Neto', 'oldOrganization': 'GEOCC'}}}}