- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07481227
FS-LASIK Versus TransPRK for Mixed Astigmatism
March 15, 2026 updated by: Mahmoud Abdel-Radi, Assiut University
Comparative Study of Femtosecond Laser-assisted LASIK and Single-step Transepithelial Photorefractive Keratectomy for Correction of Mixed Astigmatism
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
39
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Asyut Governorate
-
Asyut, Asyut Governorate, Egypt, 71515
- TIBA Eye Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
This was a retrospective comparative study conducted at Tiba eye center (private practice).
The 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.
Description
Inclusion Criteria:
- Mixed astigmatism (Plus sphere up to +4 diopters D and a minus cylinder up to -6 D).
- Stable refraction.
- Clear cornea.
- Normal corneal tomography.
Exclusion Criteria:
- Corrected distance visual acuity worse than 20/32 Snellen's acuity.
- Difference between manifest and cycloplegic refraction ≥ 1 D.
- Previous corneal or ocular surgeries, other ocular diseases.
- Systemic diseases including diabetes mellitus and autoimmune diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) group
|
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.
|
|
Single-step transepithelial photorefractive keratectomy (TransPRK) group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Uncorrected distance visual acuity (UDVA)
Time Frame: 24 months
|
Visual acuity measurement using Snellen's Acuity Chart converted to logMAR notation.
|
24 months
|
|
Corrected distance visual acuity (CDVA)
Time Frame: 24 months
|
Corrected visual acuity measurement using Snellen's Acuity Chart and converted to logMAR notation.
|
24 months
|
|
Postoperative refraction
Time Frame: 24 months
|
Manifest sphere and cylinder measured by Topcon Auto-Keratorefractometer
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2019
Primary Completion (Actual)
June 15, 2025
Study Completion (Actual)
June 15, 2025
Study Registration Dates
First Submitted
March 15, 2026
First Submitted That Met QC Criteria
March 15, 2026
First Posted (Actual)
March 18, 2026
Study Record Updates
Last Update Posted (Actual)
March 18, 2026
Last Update Submitted That Met QC Criteria
March 15, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FSVPRKMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mixed Astigmatism
-
Carl Zeiss Meditec, Inc.CompletedMixed AstigmatismUnited States
-
Bausch & Lomb IncorporatedNot yet recruiting
-
London Vision ClinicOptana GmbHActive, not recruitingCorneal AstigmatismUnited Kingdom
-
Eye Hospital Pristina KosovoActive, not recruiting
-
Yonsei UniversityUnknownMyopic AstigmatismKorea, Republic of
-
Abbott Medical OpticsCompletedRefractive AstigmatismAustria
-
Ziemer Ophthalmic Systems AGTigermed Consulting Co., LtdRecruitingMyopic AstigmatismChina
-
Bausch & Lomb IncorporatedCompleted
-
CooperVision, Inc.CompletedAstigmatism BilateralCanada
-
University Clinic FrankfurtCompleted
Clinical Trials on Femtosecond laser-assisted LASIK
-
Istanbul UniversityCompletedAnterior Chamber Inflammation | Cornea | Refractive SurgeryTurkey
-
Assiut UniversityCompletedPatients With Myopic Spherical Equivalent up to -12 DioptersEgypt
-
Peking University Third HospitalRecruiting
-
The Cleveland ClinicAlcon ResearchCompleted
-
Stanford UniversityCompletedAstigmatism | MyopiaUnited States
-
Alcon ResearchCompletedMyopia | HyperopiaUnited States
-
University Clinic FrankfurtCompleted
-
University of MichiganCompleted
-
Medical University of ViennaCompleted