Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-04 @ 8:40 AM
Study NCT ID:
NCT02512432
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2015-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2015-07-29', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal mapping to measure corneal thickness and steepening', 'timeFrame': '1 year', 'description': 'Corneal Topography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Keratoconus']}, 'descriptionModule': {'briefSummary': 'To join established study put on by Addition Technologies, Inc. in the surgical implantation of asymmetrical INTACS segments to treat myopia and astigmatism in patients with keratoconus.', 'detailedDescription': 'Use of asymmetrical corneal inserts to reduce or eliminate myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for corneal transplantation may potentially be deferred.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 21 years of age, or older\n* have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.\n* have clear central corneas\n* have a corneal thickness of 450 microns or greater at the proposed incision site\n* have corneal transplantation as the only remaining option to improve their visual function\n\nExclusion Criteria:\n\n* under 21 years of age\n* have not experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.\n* do not have clear central corneas\n* do not have a corneal thickness of 450 microns or greater at the proposed incision site\n* do not have corneal transplantation as the only remaining option to improve their visual function'}, 'identificationModule': {'nctId': 'NCT02512432', 'acronym': 'INTACS', 'briefTitle': 'INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia', 'orgStudyIdInfo': {'id': '150826'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Keratoconus', 'interventionNames': ['Device: INTACS']}], 'interventions': [{'name': 'INTACS', 'type': 'DEVICE', 'description': 'asymmetrical corneal inserts to reduce, or eliminate myopia and astigmatism in patients with keratoconus to decrease dependence on contact lenses and spectacle correction, while potentially deferring need for corneal transplantation.', 'armGroupLabels': ['Keratoconus']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Onnie Parker', 'role': 'CONTACT', 'email': 'oparker@ucsd.edu', 'phone': '8588224848'}], 'overallOfficials': [{'name': 'Christopher Heichel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego, Shiley Eye Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor', 'investigatorFullName': 'Christopher Heichel, MD', 'investigatorAffiliation': 'University of California, San Diego'}}}}