Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 5:43 PM
Study NCT ID:
NCT07481227
Status:
COMPLETED
Last Update Posted:
2026-03-18
First Post:
2026-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FS-LASIK Versus TransPRK for Mixed Astigmatism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-15', 'studyFirstSubmitDate': '2026-03-15', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected distance visual acuity (UDVA)', 'timeFrame': '24 months', 'description': "Visual acuity measurement using Snellen's Acuity Chart converted to logMAR notation."}, {'measure': 'Corrected distance visual acuity (CDVA)', 'timeFrame': '24 months', 'description': "Corrected visual acuity measurement using Snellen's Acuity Chart and converted to logMAR notation."}, {'measure': 'Postoperative refraction', 'timeFrame': '24 months', 'description': 'Manifest sphere and cylinder measured by Topcon Auto-Keratorefractometer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Astigmatism', 'Mixed astigmatism', 'FS-LASIK', 'TransPRK'], 'conditions': ['Mixed Astigmatism']}, 'referencesModule': {'references': [{'pmid': '33252566', 'type': 'BACKGROUND', 'citation': 'Kaluzny BJ, Verma S, Piotrowiak-Slupska I, Kaszuba-Modrzejewska M, Rzeszewska-Zamiara J, Stachura J, Arba-Mosquera S. Three-year outcomes of mixed astigmatism correction with single-step transepithelial photorefractive keratectomy with a large ablation zone. J Cataract Refract Surg. 2021 Apr 1;47(4):450-458. doi: 10.1097/j.jcrs.0000000000000476.'}, {'pmid': '35167040', 'type': 'BACKGROUND', 'citation': 'Moshirfar M, Durnford K, Megerdichian A, Thomson A, Martheswaran T, West W Jr, McCabe S, Ronquillo Y, Hoopes P. Refractive Outcomes After LASIK for the Treatment of Mixed Astigmatism with the Allegretto WaveLight EX500. Ophthalmol Ther. 2022 Apr;11(2):785-795. doi: 10.1007/s40123-022-00472-4. Epub 2022 Feb 15.'}]}, 'descriptionModule': {'briefSummary': 'Mixed astigmatism is a type of refractive error in which the two principal steep and flat meridians focus the light in front and behind the retina, respectively.1 Laser vision correction (LVC) for mixed astigmatism is challenging as it involves a bitoric ablative pattern to flatten the steepest meridian and steepen the flattest one. The aim of the current study was to compare the visual and refractive outcomes of FS-LASIK versus single-step TransPRK for treatment of patients with mixed astigmatism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective comparative study conducted at Tiba eye center (private practice).\n\nThe study reviewed and analyzed the records of patients with mixed astigmatism who underwent femtosecond laser-assisted LASIK (FS-LASIK group) or single-step TransPRK (TransPRK group) and completed 24 months of follow-up.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Mixed astigmatism (Plus sphere up to +4 diopters D and a minus cylinder up to -6 D).\n* Stable refraction.\n* Clear cornea.\n* Normal corneal tomography.\n\nExclusion Criteria:\n\n* Corrected distance visual acuity worse than 20/32 Snellen's acuity.\n* Difference between manifest and cycloplegic refraction ≥ 1 D.\n* Previous corneal or ocular surgeries, other ocular diseases.\n* Systemic diseases including diabetes mellitus and autoimmune diseases."}, 'identificationModule': {'nctId': 'NCT07481227', 'briefTitle': 'FS-LASIK Versus TransPRK for Mixed Astigmatism', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparative Study of Femtosecond Laser-assisted LASIK and Single-step Transepithelial Photorefractive Keratectomy for Correction of Mixed Astigmatism', 'orgStudyIdInfo': {'id': 'FSVPRKMA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) group', 'interventionNames': ['Procedure: Femtosecond laser-assisted LASIK']}, {'label': 'Single-step transepithelial photorefractive keratectomy (TransPRK) group', 'interventionNames': ['Procedure: Single-step transepithelial PRK']}], 'interventions': [{'name': 'Femtosecond laser-assisted LASIK', 'type': 'PROCEDURE', 'description': 'Patients in the FS-LASIK group underwent flap creation using the femtosecond laser WaveLight FS200® (Alcon lab, TX, USA). After flap creation, wave-front optimized stromal ablation was performed with WaveLight EX-500 (WaveLight®; Alcon Laboratories, Fort Worth, TX, USA) for mixed astigmatism correction.', 'armGroupLabels': ['Femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) group']}, {'name': 'Single-step transepithelial PRK', 'type': 'PROCEDURE', 'description': 'Patients in the single-step TransPRK group underwent StreamLight® PRK in WaveLight EX-500 Excimer laser (WaveLight®; Alcon Laboratories, Fort Worth, TX, USA). In a single step, epithelial ablation (based on epithelial mapping) followed by stromal ablation for mixed astigmatism correction, were accomplished.', 'armGroupLabels': ['Single-step transepithelial photorefractive keratectomy (TransPRK) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'TIBA Eye Center', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mahmoud Abdel-Radi', 'investigatorAffiliation': 'Assiut University'}}}}