Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-30 @ 11:40 PM
Study NCT ID:
NCT02617368
Status:
COMPLETED
Last Update Posted:
2015-12-01
First Post:
2015-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste 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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-25', 'studyFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spherical Component (SphRmin)', 'timeFrame': 'One Day', 'description': 'Spherical Component (SphRmin) displays the arithmetic mean of all radii of curvature for each ring'}, {'measure': 'Spherical Eccentricity (SphEcc)', 'timeFrame': 'One Day', 'description': 'Spherical Eccentricity is the asphericity that is calculated'}, {'measure': 'Maximum Decentration (MaxDec)', 'timeFrame': 'One Day', 'description': 'decentration or asymmetry of the astigmatic component which is derived from first order component of fourier analysis'}, {'measure': 'Regular Astigmatism at the Center(AstC)', 'timeFrame': 'One Day', 'description': 'the regular astigmatic component is calculated in the center and it is derived from the second order component of Fourier Analysis'}, {'measure': 'Regular Astigmatism at the Periphery (AstP)', 'timeFrame': 'One day', 'description': 'the regular astigmatic component is calculated in the periphery and it is derived from the second order component of Fourier Analysis'}, {'measure': 'Mean Astigmatism (MAst)', 'timeFrame': 'One Day', 'description': 'Mean Astigmatism is the average of astigmatism at the center and the periphery (MAst)'}, {'measure': 'Irregularitiy (Irr)', 'timeFrame': 'one Day'}, {'measure': 'Astigmatism at the Center plus the Irregularities (AstCir)', 'timeFrame': 'One day', 'description': 'the irregularities of the cornea which can not be corrected by sphere, cylinder or prism and it is derived from higher order components of Fourier Analysis of Keratometric Data'}, {'measure': 'Total Astigmatism (Tast) which is the sum of Mean Astigmatism and Irregularities.', 'timeFrame': 'One Day', 'description': 'Total Astigmatism (Tast) is the sum of Mean Astigmatism and Irregularities.'}]}, 'conditionsModule': {'keywords': ['Keratoconus, Corneal crosslinking, Fourier Analysis of Topographic Data'], 'conditions': ['Keratoconus']}, 'descriptionModule': {'briefSummary': 'Primary objective of this study was evaluate the diagnostic capacity of fourier analysis of keratometric data in differentiating moderate KC and FFK from healthy corneas.\n\nStudy participants were recruited from the Cornea Outpatient service in a consecutive if eligible basis. Two study groups were formed: a)KC group included patients those were diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system, b) FFK group (FFKG) that included patients diagnosed with FFK, and c) Control group (CG) was formed by refractive surgery candidates. Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same experienced operator in a consistent way.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All participants were recruited from the Outpatients Cornea service, in a consecutive if eligible basis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of keratoconus KC in the fellow eye according to the Amsler-Krumleich criteria (FFKG)\n* KISA index between 60 and 100% in the FFK eye (FFKG)\n* lack of any KC-related findings / signs in the slit-lamp biomicroscopy (FFKG)\n* uneventful ophthalmologic history (CG)\n* no indications of corneal pathology in slit-lamp biomicroscopy and Placido \\*disk-based videokeratography (CG)\n* KISA index value less than 60% (CG)\n* diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system (KCG)\n\nExclusion Criteria:\n\n* for all study groups:\n\n * previous incisional eye surgery\n * corneal scars and opacities\n * history of herpetic keratitis, severe eye dryness\n * pregnancy or nursing\n * current corneal infection\n * glaucoma\n * suspicion for glaucoma\n * IOP lowering treatment\n * underlying autoimmune disease'}, 'identificationModule': {'nctId': 'NCT02617368', 'acronym': 'FFTKC', 'briefTitle': 'Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus', 'organization': {'class': 'OTHER', 'fullName': 'Democritus University of Thrace'}, 'officialTitle': 'Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus', 'orgStudyIdInfo': {'id': '304/23/11/2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'KC group', 'description': 'KC group included patients those were diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system'}, {'label': 'Forme Fruste Keratoconus Group (FFKG)', 'description': 'Forme Fruste Keratoconus Group (FFKG) included patients diagnosed with FFK.'}, {'label': 'Control Group (CG)', 'description': 'Control group(CG) was formed by refractive surgery candidates.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Alexandroupoli', 'state': 'Evros', 'country': 'Greece', 'facility': 'Eye Institute Of Thrace', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Democritus University of Thrace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Professor in Ophthalmology', 'investigatorFullName': 'Georgios Labiris', 'investigatorAffiliation': 'Democritus University of Thrace'}}}}