Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-26 @ 5:47 PM
Study NCT ID:
NCT00934804
Status:
TERMINATED
Last Update Posted:
2018-07-23
First Post:
2009-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of the Galilei Analyzer to Calculate the Effective Corneal Power After Corneal Refractive 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Principal Investigator separating employment from University.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2009-07-06', 'studyFirstSubmitQcDate': '2009-07-07', 'lastUpdatePostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the Galilei to calculate the effective corneal power (keratometry, corneal curvature) in patients who have undergone both corneal refractive surgery and lens extraction with intraocular lens implantation.', 'timeFrame': 'Three Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['refractive surgery'], 'conditions': ['Cataracts']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the accuracy of the Galilei corneal analyzer to calculate the effective corneal power (keratometry, corneal curvature) in patients who have undergone both corneal refractive surgery and lens extraction with intraocular lens implantation.', 'detailedDescription': "The accuracy of IOL calculation is important for the visual outcome of patients undergoing cataract extraction and IOL implantation. Different formulas such as Holladay I, HofferQ, SRKT have been used with excellent results. All formulas use the corneal power among other factors to calculate the IOL power. Corneal refractive surgery i.e. radial keratotomy (RK), photorefractive keratectomy (PRK), and Laser in situ keratomileusis (LASIK) changes the corneal power; therefore, it is difficult to measure the true corneal power after surgery by any form of direct measurement, such as keratometry, or corneal topography. Keratometry and topography assume a normal relationship between the anterior and posterior corneal curvatures, and measure the anterior corneal radius. RK for myopia flattens both the anterior corneal radius and the posterior corneal radius while PRK and LASIK for myopia flattens the anterior corneal radius but leaves the posterior corneal radius mostly unchanged.\n\nStandard keratometry measures an intermediate area and extrapolates the central power based on some very broad assumptions. For this reason, keratometry, autokeratometry and simulated keratometry by topography will typically over-estimate central corneal power following keratorefractive surgery for myopia. This inaccuracy leads to an inability to meet the patients' rising expectations and with the increasing popularity of refractive surgery, calculating intraocular lens (IOL) power after refractive surgery is becoming increasingly important.\n\nDifferent methods to calculate the effective corneal power (keratometry) after refractive surgery have been described (historical data, effective refractive power, modified Maloney method, etc), however, intraocular lens power calculations in eyes with previous refractive surgery remains difficult because of the inaccuracy of keratometry power measurements.\n\nThe Galilei dual Scheimpflug analyzer is a non-invasive, diagnostic system that combines dual rotating Scheimpflug camera measurements and Placido optical system for corneal topography and 3D analysis of the anterior eye segment. It provides pachymetry as well as elevation and curvature mapping of the cornea. Additionally, the Ray tracing system delivers a more accurate total corneal power and anterior chamber depth. The total corneal power that the Galilei provides is an alternative that seems to be more accurate to calculate the IOL power in patients who have undergone keratorefractive surgery prior to cataract extraction and IOL implantation.\n\nThe purpose of this study is to determine the accuracy of the Galilei to calculate the effective corneal power (keratometry, corneal curvature) in patients who have undergone both corneal refractive surgery and lens extraction with intraocular lens implantation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects MUST fulfill the following conditions to qualify for enrollment into the trial:\n\n * Subject must have undergone corneal refractive surgery (RK, PRK or LASIK) prior to cataract extraction.\n * Age: 40 to 80 years old.\n * Subjects must have undergone cataract extraction at least 4 weeks prior to enrollment in this trial.\n * Willing and able to comply with scheduled visits and other study procedures.\n\nExclusion Criteria:\n\nSubjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.\n\nPreoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphtalmus or macrophtalmus, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.\n\nUncontrolled diabetes. Use of any systemic or topical drug known to interfere with visual performance. Contact lens use during the active treatment portion of the trial. Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.\n\nParticipation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.\n\nIntraocular conventional surgery (other than cataract extraction) within the past three months or intraocular laser surgery within one month in the operated eye.'}, 'identificationModule': {'nctId': 'NCT00934804', 'acronym': 'Galilei', 'briefTitle': 'Accuracy of the Galilei Analyzer to Calculate the Effective Corneal Power After Corneal Refractive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Accuracy of the Galilei Analyzer to Calculate the Effective Corneal Power After Corneal Refractive Surgery', 'orgStudyIdInfo': {'id': '19183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comparative Diagnostic system', 'description': 'Galilei dual Scheimpflug analyzer', 'interventionNames': ['Device: Galilei dual Scheimpflug analyzer']}], 'interventions': [{'name': 'Galilei dual Scheimpflug analyzer', 'type': 'DEVICE', 'otherNames': ['Holladay I, HofferQ, SRKT'], 'description': 'The Galilei dual Scheimpflug analyzer is a non-invasive, diagnostic system that combines dual rotating Scheimpflug camera measurements and Placido optical system for corneal topography and 3D analysis of the anterior eye segment.', 'armGroupLabels': ['Comparative Diagnostic system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Helga Sandoval, MD', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Helga P. Sandoval, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina, Storm Eye Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}