Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-31 @ 4:44 PM
Study NCT ID:
NCT06860061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2025-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes of Higher-Order Aberrations After Different Types of LASIK in Myopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-01', 'studyFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2025-03-01', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of corneal higher-order aberrations', 'timeFrame': '1 year', 'description': "Corneal aberrometry will be performed using Sirius's Scheimpflug-Placido topography (CSO, Florence, Italy)."}, {'measure': 'Changes of total ocular higher-order aberrations', 'timeFrame': '1 year', 'description': 'Wavefront refraction will be acquired by the iDesign aberrometer (Hartmann-Shack Aberrometer)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Conventional LASIK, Femto-LASIK and PRK in Low and Moderate Myopia']}, 'descriptionModule': {'briefSummary': 'This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '45 Weeks', 'minimumAge': '18 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge: 18 - 45 years old.\n\nRefraction:\n\nLow and moderate grades of myopia will be included:\n\n(According to manifest refraction) low (\\[0\\] - ≤ \\[-3\\] diopters) Moderate (\\[-3\\] - ≤ \\[-6\\] diopters) With cylinder ≤ \\[-1.5\\] diopters.\n\nExclusion Criteria:\n\nAny ocular surgery or medication, corneal opacities, pregnancy, lactation and keratoconus.'}, 'identificationModule': {'nctId': 'NCT06860061', 'briefTitle': 'Changes of Higher-Order Aberrations After Different Types of LASIK in Myopia', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Changes of Corneal and Total Ocular Higher-Order Aberrations After Conventional LASIK, Femto-LASIK and PRK in Low and Moderate Myopia', 'orgStudyIdInfo': {'id': 'Soh-Med-24-12-4MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1', 'description': 'Conventional Lasik', 'interventionNames': ['Procedure: Laser refractive surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2', 'description': 'Femto LASIK', 'interventionNames': ['Procedure: Laser refractive surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 3', 'description': 'PRK', 'interventionNames': ['Procedure: Laser refractive surgery']}], 'interventions': [{'name': 'Laser refractive surgery', 'type': 'PROCEDURE', 'description': "This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).\n\nAll patients will be subjected to routine comprehensive preoperative examinations including manifest uncorrected distant visual acuity (UCDVA), best corrected distant visual acuity (BCDVA), slit-lamp examination, intraocular pressure, and fundus examination.\n\nCorneal topography and corneal aberrometry will be performed on all patients using Sirius's Scheimpflug-Placido topography (CSO, Florence, Italy). The CSO topography system analyzes a total of 6144 corneal points of a corneal area within a circular annulus outlined by an inner radius of 0.33 mm and an outer", 'armGroupLabels': ['group 1', 'group 2', 'group 3']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ahmed abdeen, Master', 'role': 'CONTACT', 'email': 'ophthabdeen@gmail.com', 'phone': '+201003700245'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master degree ophthalmology department faculty of medicine Sohag University', 'investigatorFullName': 'Ahmed Abdeen Refai', 'investigatorAffiliation': 'Sohag University'}}}}