Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-04-22 @ 3:58 PM
Study NCT ID:
NCT00599950
Status:
TERMINATED
Last Update Posted:
2024-05-30
First Post:
2008-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}, {'id': 'D018903', 'term': 'Photorefractive Keratectomy'}], 'ancestors': [{'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D048988', 'term': 'Corneal Surgery, Laser'}, {'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000074431', 'term': 'Keratectomy'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Undefined', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2008-01-08', 'studyFirstSubmitQcDate': '2008-01-23', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A central scan of the anterior stroma was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy)', 'timeFrame': 'Before surgery and 1 week, 1 month, 3 months, 6 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mitomycin C', 'Corneal epithelium', 'Photorefractive keratectomy (PRK)', 'Confocal microscope'], 'conditions': ['Refractive Disorders']}, 'referencesModule': {'references': [{'pmid': '18046999', 'type': 'BACKGROUND', 'citation': 'Midena E, Gambato C, Miotto S, Cortese M, Salvi R, Ghirlando A. Long-term effects on corneal keratocytes of mitomycin C during photorefractive keratectomy: a randomized contralateral eye confocal microscopy study. J Refract Surg. 2007 Nov;23(9 Suppl):S1011-4. doi: 10.3928/1081-597X-20071102-06.'}, {'pmid': '17912939', 'type': 'BACKGROUND', 'citation': 'Ghirlando A, Gambato C, Midena E. LASEK and photorefractive keratectomy for myopia: clinical and confocal microscopy comparison. J Refract Surg. 2007 Sep;23(7):694-702. doi: 10.3928/1081-597X-20070901-08.'}, {'pmid': '17444091', 'type': 'BACKGROUND', 'citation': 'Ying L, Xiao Z, Liuxueying Z, Yumei J. Clinical use of in vivo confocal microscopy through focusing in corneal refractive surgery. J Refract Surg. 2006 Nov;22(9 Suppl):S1041-6. doi: 10.3928/1081-597X-20061102-07.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the confocal microscopy changes in keratocyte density at the anterior stromal after Photorefractive keratectomy (PRK) surgery, using intraoperative mitomycin C(Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA).', 'detailedDescription': '10 eyes of 10 patients underwent PRK,using intraoperative mitomycin C (Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA), and 10 eyes for the same patients underwent PRK without intraoperative mitomycin C. A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) after surgery, and 1 week, 1 month, 3 months, and 6 months after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ask for PRK surgery\n* Patients with stable refraction in the last year\n* Patients without systemic and ocular disease\n* Patients with 500 microns in pachymetry normal topography\n\nExclusion Criteria:\n\n* Patients cannot attend their appointments\n* Residual, recurrent or active ocular disease\n* Previous ocular surgery except PRK\n* Autoimmune or connective tissue disease\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00599950', 'briefTitle': 'Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.', 'orgStudyIdInfo': {'id': 'Cornea 4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)', 'interventionNames': ['Drug: Mitomycin C and Photorefractive keratectomy (PRK)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Photorefractive keratectomy (PRK)without mitomycin C.', 'interventionNames': ['Drug: Mitomycin C and Photorefractive keratectomy (PRK)']}], 'interventions': [{'name': 'Mitomycin C and Photorefractive keratectomy (PRK)', 'type': 'DRUG', 'description': 'Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04030', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Ramirez F Manuel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Asociación para Evitar la Ceguera en México', 'oldOrganization': 'Asociación para Evitar la Ceguera en México'}}}}