Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT00917657
Status:
COMPLETED
Last Update Posted:
2009-06-10
First Post:
2009-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018903', 'term': 'Photorefractive Keratectomy'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-09', 'studyFirstSubmitDate': '2009-06-09', 'studyFirstSubmitQcDate': '2009-06-09', 'lastUpdatePostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['photorefractive keratectomy', 'hyperopia', 'radial keratotomy', 'refractive surgery'], 'conditions': ['Hyperopia']}, 'referencesModule': {'references': [{'pmid': '20549047', 'type': 'DERIVED', 'citation': 'Ghanem RC, Ghanem EA, Kara-Jose N. [Safety of photorefractive keratectomy with mitomycin-C for the treatment of hyperopia after radial keratotomy]. Arq Bras Oftalmol. 2010 Mar-Apr;73(2):165-70. doi: 10.1590/s0004-27492010000200013. Portuguese.'}, {'pmid': '20464118', 'type': 'DERIVED', 'citation': 'Ghanem RC, Ghanem EA, Kara-Jose N. [Corneal wavefront-guided photorefractive keratectomy with mitomycin-C for consecutive hyperopia after radial keratotomy]. Arq Bras Oftalmol. 2010 Jan-Feb;73(1):70-6. doi: 10.1590/s0004-27492010000100013. Portuguese.'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy, predictability, stability and safety of corneal wavefront-guided photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial keratotomy (RK).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hyperopia or hyperopic astigmatism with spherical equivalent of up to + 9,25 D and astigmatism of up to - 4,5 D;\n* Uncorrected Visual Acuity of 20/40 or worse;\n* Best-Corrected Visual Acuity of 20/60 or better.\n\nExclusion Criteria:\n\n* Systemic or ocular conditions that could bias results\n* Previous photorefractive surgery'}, 'identificationModule': {'nctId': 'NCT00917657', 'briefTitle': 'Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Corneal Wavefront-Guided PRK With Adjunctive Mitomycin-C for the Treatment of Hyperopia After Radial Keratotomy', 'orgStudyIdInfo': {'id': '1183/07'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Photorefractive keratectomy', 'type': 'PROCEDURE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Newton Kara-José, MD', 'oldOrganization': 'University of Sao Paulo'}}}}