Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT04286620
Status:
UNKNOWN
Last Update Posted:
2020-02-27
First Post:
2020-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ASSESSMENT OF INTRA-OPERATIVE AND EARLY POST-OPERATIVE LASIK COMPLICATIONS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of Intra-operative and early post-operative complications of LASIK', 'timeFrame': 'Baseline', 'description': 'Assessment of post-LASIK complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LASIK complications'], 'conditions': ['Cornea']}, 'descriptionModule': {'briefSummary': 'To discuss the prevalence of intra-operative and early post-operative complications of LASIK among individuals who underwent LASIK procedure and review the symptoms, findings, and management options.', 'detailedDescription': 'In recent years, a number of possible surgical procedures in ophthalmology has offered patients an alternative to spectacles or contact lenses. Several laser and non-laser refractive surgical procedures have been used to modify the shape of the cornea and correct myopia, hyperopia, astigmatism, and presbyopia. Introduction of the excimer laser to reshape the cornea has resulted in remarkable developments in the correction of refractive errors. Combined with other advanced ophthalmic instruments, laser refractive eye surgery has resulted in a substantial increase in the safety, efficacy, and predictability of surgical outcomes.\n\nRefractive surgery has enabled individuals to enter occupations they were previously precluded from due to their vision.Laser in situ keratomileusis (LASIK) surgery is one of the most common surgeries performed worldwide to correct refractive errors and reduce dependence on eyeglasses or contact lenses. In addition, patient satisfaction following LASIK is commonly reported as high and studies of the visual and refractive outcome of LASIK for the treatment of myopia and astigmatism have reported great success.\n\nLASIK, compared to photorefractive keratectomy (PRK), has low postoperative discomfort, early visual rehabilitation and decreased postoperative haze. LASIK involves an additional procedure of creating a corneal flap. This may result in complications related to the flap, interface and underlying stromal bed. The common flap-related complications include thin flap, button holing, free caps, flap dislocation, torn flap, incomplete cut, and flap striae. The interface complications of diffuse lamellar keratitis, epithelial ingrowth and microbial keratitis are potentially sight threatening. After LASIK, there is a long period of sensory denervation leading to the complication of dry eyes. The refractive complications include under-correction, over-correction, regression, irregular astigmatism, and visual aberrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parameters to be included: demographic data, history, symptoms, post-operative uncorrected and best corrected visual acuities, examination findings, and treatment recommendations.\n\nDocumentation of complications.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who are scheduled for LASIK surgery\n\nExclusion Criteria:\n\n* history of previous ocular surgery, and inadequate follow up.'}, 'identificationModule': {'nctId': 'NCT04286620', 'briefTitle': 'ASSESSMENT OF INTRA-OPERATIVE AND EARLY POST-OPERATIVE LASIK COMPLICATIONS', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'ASSESSMENT OF INTRA-OPERATIVE AND EARLY POST-OPERATIVE LASIK COMPLICATIONS', 'orgStudyIdInfo': {'id': 'LASIK complications'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LASIK', 'type': 'DEVICE', 'description': 'Correcting errors of refraction'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abdelrahman M Saad', 'role': 'CONTACT', 'email': 'arabasdm.23@gmail.com', 'phone': '+201067895256'}], 'overallOfficials': [{'name': 'Tarek A Mohamed, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ophthalmology department, faculty of medicine, Assiut university hospital'}, {'name': 'Dalia M El-Sebity, Ass.prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ophthalmology department, faculty of medicine, Assiut university hospital'}, {'name': 'Khaled A Mohammed, Ass.prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ophthalmology department, faculty of medicine, Assiut university hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'House officer', 'investigatorFullName': 'Abdelrahman Mohamed saad', 'investigatorAffiliation': 'Assiut University'}}}}