Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-16 @ 6:46 PM
Study NCT ID:
NCT02893592
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2016-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency, Predictability and Security of the Trans-epithelial Photorefractive Keratectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2016-08-30', 'studyFirstSubmitQcDate': '2016-09-07', 'lastUpdatePostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual acuity', 'timeFrame': 'Month 2', 'description': 'LogMar'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': "The photorefractive keratectomy was the first correction mode refractive laser. It's a photo-ablation of a predetermined thickness of anterior corneal stroma. Debridement of epithelium can be done either mechanically (m-PRK) or by laser (trans-PRK). Trans-PRK has a lot of interests: facility and speed of procedure as well as suppression of human variable. Very good results are obtained by m-PRK. The aim of this study is to show equivalence or non inferiority of trans-PRK over conventional m-PRK in terms of safety and refractive efficiency"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Were included patients with myopia up to -4D (dioptries) and cylinders up to -3D.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with stable refractive error (more than 2 years)\n* Myopia up to -4.00 diopters and astigmatism up to -3.00 diopters\n\nExclusion Criteria:\n\n* Phototherapeutic keratectomy (PTK)'}, 'identificationModule': {'nctId': 'NCT02893592', 'acronym': 'MYOPAS', 'briefTitle': 'Efficiency, Predictability and Security of the Trans-epithelial Photorefractive Keratectomy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Efficiency, Predictability and Security of the Trans-epithelial Photorefractive Keratectomy (Trans-PRK) for Low and Medium Myopia and Astigmatism: Retrospective Study About 118 Eyes', 'orgStudyIdInfo': {'id': '2015-11Obs-CHRMT'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}