Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2026-03-06 @ 4:51 PM
Study NCT ID:
NCT06806306
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2025-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Preoperative Risk Factors for the Development of Post-LASIK Ectasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Randleman ectasia score', 'timeFrame': 'At the baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lasik Eye Surgery']}, 'descriptionModule': {'briefSummary': ': Laser-assisted in situ keratomileusis (LASIK) is one of the most widely performed refractive surgeries, offering effective and long-lasting correction for visual refractive errors. While LASIK has a high success rate and is generally safe, post-LASIK ectasia remains a rare but serious complication that compromises visual outcomes. Several risk factors for post-LASIK ectasia have been identified. The aim of the present study is to determine the preoperative risk factors for the development of post-LASIK ectasia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'LASIK patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of corneal ectasia was made by progressive central or inferior corneal steepening, increased myopia and/or astigmatism, and decreased visual acuity\n\nExclusion Criteria:\n\n* Subjects who had glaucoma diagnosis, other corneal surgeries (other than LASIK), and central corneal opacity'}, 'identificationModule': {'nctId': 'NCT06806306', 'briefTitle': 'Assessment of the Preoperative Risk Factors for the Development of Post-LASIK Ectasia', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Assessment of the Preoperative Risk Factors for the Development of Post-LASIK Ectasia', 'orgStudyIdInfo': {'id': 'Post-LASIK Ectasia'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LASIK', 'type': 'PROCEDURE', 'description': 'Laser-assisted in situ keratomileusis is one of the most widely performed refractive surgeries for correcting myopia, hyperopia, and astigmatism'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Walid Shaban Abdella', 'investigatorAffiliation': 'Al-Azhar University'}}}}