Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-28 @ 9:25 PM
Study NCT ID:
NCT02625467
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2015-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Keratoconus With PALK Versus PK
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015948', 'term': 'Keratoplasty, Penetrating'}], 'ancestors': [{'id': 'D016039', 'term': 'Corneal Transplantation'}, {'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-05', 'studyFirstSubmitDate': '2015-12-01', 'studyFirstSubmitQcDate': '2015-12-05', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '6 months', 'description': 'Uncorrected and corrected distance visual acuity'}], 'secondaryOutcomes': [{'measure': 'Corneal measurements: pachymetry', 'timeFrame': '6 months', 'description': 'Evaluation of the pachymetric maps with a Scheimpflug-Placido device (Sirius). Measurement in microns'}, {'measure': 'Corneal aberrometry: Coma, spherical aberration and trefoil', 'timeFrame': '6 months', 'description': 'Evaluation of the corneal aberrations including coma, spherical aberration and trefoil, with a Scheimpflug-Placido device (Sirius)'}, {'measure': 'Corneal measurements: anterior and posterior elevation', 'timeFrame': '6 months', 'description': 'Evaluation of the elevation (anterior and posterior), maps with a Scheimpflug-Placido device (Sirius). Measurement in diopters'}, {'measure': 'Corneal measurements: keratometries.', 'timeFrame': '6 months', 'description': 'Evaluation of the keratometric map with a Scheimpflug-Placido device (Sirius). Measurement in diopters'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Keratoconus'], 'conditions': ['Keratoconus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the visual results of patients with keratoconus treated with one of two techniques: penetrating keratoplasty (PK) vs. pachymetry and Excimer laser assisted lamellar keratoplasty (PALK).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of keratoconus grades III or IV in the Amsler Krumeich classification.\n* Need of surgical procedure\n* No endothelial scar\n* Best corrected visual acuity \\<20/40\n* Contact lens intolerance\n* Imagenological map pachymetric acquisition over 90% at 9 mm corneal diameter\n\nExclusion Criteria:\n\n* Contraindication for any of the techniques evaluated.\n* Requiring additional surgical procedures.\n* Diagnostic of other ectasia that were not primary keratoconus.'}, 'identificationModule': {'nctId': 'NCT02625467', 'briefTitle': 'Treatment of Keratoconus With PALK Versus PK', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Oftalmología Fundación Conde de Valenciana'}, 'officialTitle': 'Treatment of Keratoconus With Pachymetry Assisted Laser Keratoplasty (PALK) Versus Penetrating Keratoplasty (PK)', 'orgStudyIdInfo': {'id': 'PALK vs PK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Penetrating keratoplasty', 'description': 'Conventional penetrating keratoplasty technique', 'interventionNames': ['Procedure: Penetrating keratoplasty', 'Drug: Treatment posterior to surgery']}, {'type': 'EXPERIMENTAL', 'label': 'PALK', 'description': 'Pachymetry and Excimer laser assisted lamellar keratoplasty', 'interventionNames': ['Procedure: Pachymetry and Excimer laser assisted lamellar keratoplasty', 'Drug: Treatment posterior to surgery']}], 'interventions': [{'name': 'Penetrating keratoplasty', 'type': 'PROCEDURE', 'description': 'Conventional Penetrating keratoplasty technique', 'armGroupLabels': ['Penetrating keratoplasty']}, {'name': 'Pachymetry and Excimer laser assisted lamellar keratoplasty', 'type': 'PROCEDURE', 'description': 'Ablation profile focusing on topography and pachymetry with Schwind Amaris excimer laser', 'armGroupLabels': ['PALK']}, {'name': 'Treatment posterior to surgery', 'type': 'DRUG', 'description': 'Fluoroquinolone topical antibiotic (Moxifloxacin, Vigamox) and topical steroid (Prednisolone Acetate Ophthalmic Suspension, Pred Forte)', 'armGroupLabels': ['PALK', 'Penetrating keratoplasty']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Enrique Graue Hernandez, MD, MsC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto de Oftalmologia Conde de Valenciana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Oftalmología Fundación Conde de Valenciana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}