Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT04130334
Status:
UNKNOWN
Last Update Posted:
2019-10-17
First Post:
2019-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN
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': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-15', 'studyFirstSubmitDate': '2019-10-07', 'studyFirstSubmitQcDate': '2019-10-15', 'lastUpdatePostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': '14 months', 'description': 'Snellen chart'}, {'measure': 'graft astigmatism', 'timeFrame': '14 months', 'description': 'Topography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Keratoconus']}, 'descriptionModule': {'briefSummary': "Patients with KCN who undergo cornea transplantation divided to 2 groups:\n\nGroup1: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea Group 2: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea After suture removal, best corrected visual acuity, refractive error, corneal keratometry, irregularity of corneal surface and high order aberration of two groups will compare"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with KCN who undergo DALK surgery\n\nExclusion Criteria:\n\n* Penetrating Keratoplasty surgery\n* Other corneal diseases\n* dystrophies\n* Corneal graft rejection'}, 'identificationModule': {'nctId': 'NCT04130334', 'briefTitle': 'Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN: a Clinical Trial', 'orgStudyIdInfo': {'id': '10000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "horizontal meridian of donor's cornea sutured to horizontal", 'description': "horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea", 'interventionNames': ["Procedure: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea"]}, {'type': 'ACTIVE_COMPARATOR', 'label': "horizontal meridian of donor's cornea sutured to vertical", 'description': "horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea", 'interventionNames': ["Procedure: : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea"]}], 'interventions': [{'name': "After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea", 'type': 'PROCEDURE', 'description': "After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea", 'armGroupLabels': ["horizontal meridian of donor's cornea sutured to horizontal"]}, {'name': ": After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea", 'type': 'PROCEDURE', 'description': ": After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea", 'armGroupLabels': ["horizontal meridian of donor's cornea sutured to vertical"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Sepehr Feizi, MD', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '009822591616'}], 'facility': 'Ophthalmic Research Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Sepehr Feizi, MD', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '009822591616'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of ophthalmic research center', 'investigatorFullName': 'Zahra Rabbani Khah', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}