Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-03-01 @ 10:04 AM
Study NCT ID:
NCT00593359
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2008-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraocular Pressure During Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-19', 'studyFirstSubmitDate': '2008-01-02', 'studyFirstSubmitQcDate': '2008-01-02', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be the maximum intraocular pressure at any time during surgery.', 'timeFrame': '15 days post surgery'}], 'secondaryOutcomes': [{'measure': 'Intraocular pressure as a function of surgical duration; Velocity of retrobulbar blood flow; Facial edema and or chemosis; Time to extubation; Duration of recovery Correlation between Dpp and FTc.', 'timeFrame': '15 days post surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinal surgery', 'Prone spinal surgery'], 'conditions': ['Intraocular Pressure']}, 'descriptionModule': {'briefSummary': "This study will compare the effect of two intravenous solutions on eye pressure during spine surgery in the following groups:\n\nGroup A - Lactated Ringer's replacement for blood loss and placebo eye drops\n\nGroup B - Lactated Ringer's replacement for blood loss and brimonidine eye drops\n\nGroup C - Albumin replacement for blood loss and placebo eye drops\n\nGroup D - Albumin replacement for blood loss and brimonidine eye drops", 'detailedDescription': 'Patients will be administered either brimonidine eye drops, or placebo eye drops, preoperatively, on the day of surgery and during surgery. Eye pressure will be measured before surgery, every 30 minutes throughout your surgery and every hour for 4 hours following surgery. Subjects will be evaluated before surgery and on days 5, 8, 15 after surgery. During these evaluations, the subject will be asked questions about recovery and his/her eyes will be checked by an ophthalmologist and vision will be tested.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing spinal surgery in the prone position for at least 5 hours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spine surgery with instrumentation in prone position expected to last at least 5 hours;\n* Anticipated blood loss ≥ 1L\n* Age 18-80 years old;\n* ASA physical status I-III.\n\nExclusion Criteria:\n\n* History of increased intraocular pressure or glaucoma;\n* Diabetic retinopathy;\n* Heart failure or serious left ventricular dysfunction;\n* Abnormal preoperative fundus examination;\n* Creatinine \\> 2 mg/dL;\n* Patient refuses blood transfusion or albumin administration'}, 'identificationModule': {'nctId': 'NCT00593359', 'briefTitle': 'Intraocular Pressure During Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': "The Effect of Lactated Ringer's Solution Versus Albumin and the Alpha-2 Agonist Brimonidine Versus Placebo on Intraocular Pressure During Prone Spine Surgery", 'orgStudyIdInfo': {'id': '07-571'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': "Lactated Ringer's replacement for blood loss and placebo eye drops"}, {'label': 'B', 'description': "Lactated Ringer's replacement for blood loss and brimonidine eye drops"}, {'label': 'C', 'description': 'Albumin replacement for blood loss and placebo eye drops;'}, {'label': 'D', 'description': 'Albumin replacement for blood loss and brimonidine eye drops'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Daniel I Sessler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}