Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-29 @ 4:47 PM
Study NCT ID:
NCT02428166
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2015-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-11', 'studyFirstSubmitDate': '2015-04-23', 'studyFirstSubmitQcDate': '2015-04-23', 'lastUpdatePostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in maximum keratometry (Kmax) as measured by the Pentacam HR', 'timeFrame': 'after completion of data collection based on the measurements preoperatively and 2-14 months postoperative'}], 'secondaryOutcomes': [{'measure': 'Change in corneal thickness as measured by the Pentacam HR', 'timeFrame': 'retrospective analysis from preoperatively to 2-14 months postoperatively'}, {'measure': 'Change in visual acuity (VA)', 'timeFrame': 'retrospective analysis from preoperatively to 2-14 months postoperatively'}, {'measure': 'Evaluation of pre-existing ocular pathology or/and ocular surgery as potential factors involved in treatment outcome', 'timeFrame': 'retrospective analysis from preoperatively to 2-14 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['crosslinking', 'keratoconus', 'keratometry', 'pachymetry', 'pentacam'], 'conditions': ['Keratoconus']}, 'descriptionModule': {'briefSummary': 'The purpose of this retrospective study is to assess corneal changes (keratometry, pachymetry) and change in visual acuity (VA) in keratoconus patients after unilateral crosslinking treatment compared to the untreated fellow eye. The corneal measurements obtained preoperatively and 2 to 14 months postoperatively using a Pentacam rotating scheimpflug camera are analyzed. Furthermore, pre-existing or actual ocular pathology or/and ocular surgeries as potential factors involved in treatment outcome are also evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible keratoconus patients aged 18-50 years who underwent unilateral crosslinking treatment in our ophthalmology department and completed a postoperative follow-up of 2-14 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Keratoconus patients after unilateral crosslinking treatment\n\nExclusion Criteria:\n\n* Morphological changes of the cornea caused be ocular infection or trauma (e.g. corneal scarring)\n* Other pre-existing corneal surgery (e.g. corneal transplantation, implantation of intrastromal corneal ring segments)'}, 'identificationModule': {'nctId': 'NCT02428166', 'briefTitle': 'Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye', 'orgStudyIdInfo': {'id': 'S-004/2015'}}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Department of ophthalmology, University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Mike P Holzer, MD, FEBO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of ophthalmology, University of Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophthalmologist, FEBO', 'investigatorFullName': 'Prof. Dr. med. Mike P. Holzer', 'investigatorAffiliation': 'Heidelberg University'}}}}