Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-16 @ 3:33 AM
Study NCT ID:
NCT02210793
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2014-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dry Eye Evaluation After Transepithelial PRK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020731', 'term': 'Keratomileusis, Laser In Situ'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-05', 'studyFirstSubmitDate': '2014-08-02', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'healing time of epithelial defect epithelial defect', 'timeFrame': '2-5 days', 'description': 'the period of time in days needed for complete healing of the epithelial defect created during transepithelial PRK'}], 'primaryOutcomes': [{'measure': 'qualitative assessment of dry eye syndrome', 'timeFrame': '6 months', 'description': 'Tear Break Up time is used as a qualitative measure of dry eye after surgery'}, {'measure': 'quantitative of dry eye after surgery', 'timeFrame': '6 months', 'description': 'Schirmer test is used as a quantitative measure of dry eye after surgery'}], 'secondaryOutcomes': [{'measure': 'haze', 'timeFrame': '6 months', 'description': 'haze is a known possible complication of surface ablation Its severity can be graded according to a slit lamp scoring system'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transepithelial PRK', 'Dry eye', 'Schirmer test', 'Tear break up time', 'Dry eye after advanced surface ablation technique'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser vision correction using no-touch all-laser photorefractive keratectomy in comparison to conventional lasik', 'detailedDescription': 'Prospective interventional clinical study 2 groups: Group A : 20 eyes of 10 patients undergoing transepithelial PRK Group B: 20 eyes of 10 patients undergoing LASIK using mechanical microkeratome Tear Break Up Time and Schirmer 2 tests are used to evaluate severity of dry eye before surgery and 1 , 3 and 6 months postoperative Follow up period : 6 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Myopia -1 to -6 diopters\n* Astigmatism -0.5 to - 4 diopters\n\nExclusion Criteria:\n\n* Pregnancy and lactation\n* Keratoconus\n* Previous refractive surgery\n* Previous herpetic keratitis'}, 'identificationModule': {'nctId': 'NCT02210793', 'briefTitle': 'Dry Eye Evaluation After Transepithelial PRK', 'organization': {'class': 'OTHER', 'fullName': 'AL-Nour Eye Hospital'}, 'officialTitle': 'Evaluation of Dry Eye Following Transepithelial Photorefractive Keratectomy in Comparison to Conventional LASIK: a Comparative Study', 'orgStudyIdInfo': {'id': 'ANH-1'}, 'secondaryIdInfos': [{'id': 'ANH-TPRK1', 'type': 'OTHER', 'domain': 'Al-Nour Eye hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transepithelial PRK', 'description': '20 eyes to undergo a no touch , all-laser advanced surface ablation technique termed transepithelial PRK using the Amaris laser platform (Schwind eye-tech solutions Gmbh, Germany)', 'interventionNames': ['Procedure: transepithelial PRK']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional LASIK', 'description': '20 eyes to undergo LASIK using a mechanical microkeratome (M2, Moria Surgical, Antony, France) and the Mel 80 excimer laser system(Carl Zeiss Meditec)', 'interventionNames': ['Procedure: LASIK']}], 'interventions': [{'name': 'transepithelial PRK', 'type': 'PROCEDURE', 'armGroupLabels': ['Transepithelial PRK']}, {'name': 'LASIK', 'type': 'PROCEDURE', 'armGroupLabels': ['Conventional LASIK']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Al Nour Eye Hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Ahmed M Shalaby, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Mahmoud H Abu Steit, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Mohamed Salah, MBBCH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AL-Nour Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Ahmed Sherif', 'investigatorFullName': 'Ahmed Mohamed Sherif', 'investigatorAffiliation': 'AL-Nour Eye Hospital'}}}}