Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-01-07 @ 8:24 PM
Study NCT ID:
NCT03511495
Status:
COMPLETED
Last Update Posted:
2019-04-22
First Post:
2018-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of Topography Measurements in Keratoconus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-19', 'studyFirstSubmitDate': '2018-03-28', 'studyFirstSubmitQcDate': '2018-04-18', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum (steepest) and minimum (flattest) keratometry values in the central zone', 'timeFrame': 'Measured at day 0 of study enrollment', 'description': 'Assessment of the steepness of the cornea'}], 'secondaryOutcomes': [{'measure': 'Thinnest pachymetry', 'timeFrame': 'Measured at day 0 of study enrollment', 'description': 'The thinnest area of the cornea'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Keratoconus']}, 'referencesModule': {'references': [{'pmid': '9493273', 'type': 'BACKGROUND', 'citation': 'Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.'}, {'pmid': '10906086', 'type': 'BACKGROUND', 'citation': 'Bawazeer AM, Hodge WG, Lorimer B. Atopy and keratoconus: a multivariate analysis. Br J Ophthalmol. 2000 Aug;84(8):834-6. doi: 10.1136/bjo.84.8.834.'}, {'pmid': '23642799', 'type': 'BACKGROUND', 'citation': 'Demir S, Sonmez B, Yeter V, Ortak H. Comparison of normal and keratoconic corneas by Galilei Dual-Scheimpflug Analyzer. Cont Lens Anterior Eye. 2013 Oct;36(5):219-25. doi: 10.1016/j.clae.2013.04.001. Epub 2013 Apr 30.'}, {'pmid': '19848378', 'type': 'BACKGROUND', 'citation': 'Holladay JT. Keratoconus detection using corneal topography. J Refract Surg. 2009 Oct;25(10 Suppl):S958-62. doi: 10.3928/1081597X-20090915-11.'}, {'pmid': '24938125', 'type': 'BACKGROUND', 'citation': 'Guler E, Yagci R, Akyol M, Arslanyilmaz Z, Balci M, Hepsen IF. Repeatability and reproducibility of Galilei measurements in normal keratoconic and postrefractive corneas. Cont Lens Anterior Eye. 2014 Oct;37(5):331-6. doi: 10.1016/j.clae.2014.04.004. Epub 2014 Jun 14.'}, {'pmid': '27993593', 'type': 'BACKGROUND', 'citation': 'Meyer JJ, Gokul A, Vellara HR, Prime Z, McGhee CN. Repeatability and Agreement of Orbscan II, Pentacam HR, and Galilei Tomography Systems in Corneas With Keratoconus. Am J Ophthalmol. 2017 Mar;175:122-128. doi: 10.1016/j.ajo.2016.12.003. Epub 2016 Dec 18.'}, {'pmid': '27195079', 'type': 'BACKGROUND', 'citation': 'Feizi S, Yaseri M, Kheiri B. Predictive Ability of Galilei to Distinguish Subclinical Keratoconus and Keratoconus from Normal Corneas. J Ophthalmic Vis Res. 2016 Jan-Mar;11(1):8-16. doi: 10.4103/2008-322X.180707.'}, {'pmid': '20628301', 'type': 'BACKGROUND', 'citation': 'Jahadi Hosseini HR, Katbab A, Khalili MR, Abtahi MB. Comparison of corneal thickness measurements using Galilei, HR Pentacam, and ultrasound. Cornea. 2010 Oct;29(10):1091-5. doi: 10.1097/ICO.0b013e3181cf98e5.'}, {'pmid': '24763122', 'type': 'BACKGROUND', 'citation': 'Anayol MA, Guler E, Yagci R, Sekeroglu MA, Ylmazoglu M, Trhs H, Kulak AE, Ylmazbas P. Comparison of central corneal thickness, thinnest corneal thickness, anterior chamber depth, and simulated keratometry using galilei, Pentacam, and Sirius devices. Cornea. 2014 Jun;33(6):582-6. doi: 10.1097/ICO.0000000000000119.'}, {'pmid': '22699561', 'type': 'BACKGROUND', 'citation': 'Park SH, Choi SK, Lee D, Jun EJ, Kim JH. Corneal thickness measurement using Orbscan, Pentacam, Galilei, and ultrasound in normal and post-femtosecond laser in situ keratomileusis eyes. Cornea. 2012 Sep;31(9):978-82. doi: 10.1097/ICO.0b013e31823d03fc.'}, {'pmid': '23540708', 'type': 'BACKGROUND', 'citation': 'Crawford AZ, Patel DV, McGhee CN. Comparison and repeatability of keratometric and corneal power measurements obtained by Orbscan II, Pentacam, and Galilei corneal tomography systems. Am J Ophthalmol. 2013 Jul;156(1):53-60. doi: 10.1016/j.ajo.2013.01.029. Epub 2013 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the reliability and repeatability of the parameters obtained using the Galilei dual-scheimpflug corneal topographer for monitoring progression in eyes with keratoconus.', 'detailedDescription': 'Keratoconus is a progressive corneal degeneration characterized by progressive steepening and thinning of the central or paracentral cornea leading to corneal protrusion and resulting irregular astigmatism and high myopia. This disorder is usually bilateral and is linked to atopy and excessive eye rubbing, although the precise pathophysiology behind development of this condition is unclear. Keratoconus is the most common corneal degeneration in the United States, affecting between 50 and 230 subjects per 100,000 population.\n\nEarly diagnosis and appropriate management of keratoconus relies greatly on accurate assessment of corneal topographic measurements. It is therefore imperative that the data obtained via corneal topography devices is accurate and reliable.\n\nThe GALILEI Dual Scheimpflug Analyzer integrates Placido disc topography and dual Scheimpflug tomography to assess anterior and posterior corneal curvature data. Although there have been several studies performed assessing the ability of the Galilei to accurately distinguish keratoconus from unaffected eyes and investigating interdevice reliability between the Galilei analyzer and other tomographers, to our knowledge the repeatability of measurements obtained in this population via the Galilei device has been incompletely evaluated to date.\n\nCorneal topography data obtained via the Galilei device is relied upon heavily in clinical decision making for keratoconic patients both in the Hershey Eye Clinic and in a great number of ophthalmology practices world-wide. It is vital that the accuracy and repeatability of these measurements obtained via the Galilei device are investigated.\n\nThe primary endpoint to be measured in the study will be the maximum (steepest) and minimum (flattest) keratometry values in the central zone.\n\nSecondary endpoints will be maximum keratometry across the entire area scanned, axis of corneal astigmatism, anterior and posterior best fit spheres in float mode with the diameter set to 8 mm, maximum anterior and posterior elevations, thinnest corneal thickness, and corneal asphericity at 6 mm, root mean square (RMS) of the HOAs, RMS of the third-order coma, coma axis, vertical and horizontal coma and spherical aberration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a prospective study of patients seen at the Penn State Eye Center who have been diagnosed with keratoconus and are undergoing Galilei corneal topography. Patients will be selected to participate in the study based on inclusion/exclusion criteria. Each patient in the study will undergo five consecutive corneal topography measurements per keratoconic eye.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patientswho are older than 18 years of age\n* Patients who are scheduled to undergo Galilei dual-scheimpflug corneal topography testing\n* Patients who have been diagnosed with keratoconus\n* Measurements with a reported reliability of 'good' from the topographer\n\nExclusion Criteria:\n\n* Patients who have undergone any prior surgical intervention involving the cornea (i.e. cornea transplant or INTACS, or corneal cross linking)"}, 'identificationModule': {'nctId': 'NCT03511495', 'briefTitle': 'Reliability of Topography Measurements in Keratoconus', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Repeatability and Reliability of Galilei Corneal Topographer Measurements in Keratoconus', 'orgStudyIdInfo': {'id': 'STUDY00007951'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Keratoconic Patients', 'interventionNames': ['Diagnostic Test: Galilei Corneal Topographer']}], 'interventions': [{'name': 'Galilei Corneal Topographer', 'type': 'DIAGNOSTIC_TEST', 'description': 'A series of five measurements via the Galilei corneal topographer of each keratoconic eye in quick succession', 'armGroupLabels': ['Keratoconic Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Eye Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Seth Pantanelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Ophthalmology', 'investigatorFullName': 'Seth M Pantanelli', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}