Mixed AstigmatismNCT07481227

FS-LASIK Versus TransPRK for Mixed Astigmatism

An observational study of Mixed Astigmatism, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Mixed Astigmatism
What is being tested?: Femtosecond laser-assisted LASIK and Single-step transepithelial PRK
Type of treatment: Surgery or procedure
How many people: 39 participants
Where: 1 siteEgypt
Study dates: 15 Jun 2019to 15 Jun 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

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.

Who may be able to join

Mixed astigmatism (Plus sphere up to +4 diopters D and a minus cylinder up to -6 D).
Stable refraction.
Clear cornea.
Normal corneal tomography.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

TIBA Eye Center
Asyut, Asyut Governorate, 71515

Other trials in Egypt

About this study

Official title: 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.

Conditions: Mixed Astigmatism
Being tested: Femtosecond laser-assisted LASIK, Single-step transepithelial PRK
Keywords: Astigmatism, Mixed astigmatism, FS-LASIK, TransPRK
Medical subject headings: Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Femtosecond laser-assisted LASIKProcedure or surgery
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 PRKProcedure or surgery
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.

Study groups in NCT07481227
Study group	Role	What they receive
Femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) group		Not described Receives: Procedure: Femtosecond laser-assisted LASIK
Single-step transepithelial photorefractive keratectomy (TransPRK) group		Not described Receives: Procedure: Single-step transepithelial PRK

What is being measured

The primary outcome is the main question the study is designed to answer.

Uncorrected distance visual acuity (UDVA)
Visual acuity measurement using Snellen's Acuity Chart converted to logMAR notation.
Measured: 24 months
Corrected distance visual acuity (CDVA)
Corrected visual acuity measurement using Snellen's Acuity Chart and converted to logMAR notation.
Measured: 24 months
Postoperative refraction
Manifest sphere and cylinder measured by Topcon Auto-Keratorefractometer
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 201915 Jun 2025

First posted18 Mar 2026
Study start15 Jun 2019
Primary completion15 Jun 2025
Study completion15 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Mixed AstigmatismStudies of the same condition, open and under way.
More trials run by Assiut UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07481227
Sponsor's protocol ID: FSVPRKMA
Status last verified: Mar 2026
First submitted: 15 Mar 2026
Last updated: 18 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33252566
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.
PubMed 35167040

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Study of Femtosecond Laser-assisted LASIK and Single-step Transepithelial Photorefractive Keratectomy for Correction of Mixed Astigmatism
ClinicalTrials.gov ID: NCT07481227
Acronym / sponsor ID: FSVPRKMA
Conditions: Mixed Astigmatism
Keywords: Astigmatism, Mixed astigmatism, FS-LASIK, TransPRK
Study type: Observational
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Assiut UniversityUniversity, hospital or other
Study start: 15 Jun 2019 (actual)
Primary completion: 15 Jun 2025 (actual)
Study completion: 15 Jun 2025 (actual)
First posted: 18 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) group	–	Procedure: Femtosecond laser-assisted LASIK
Single-step transepithelial photorefractive keratectomy (TransPRK) group	–	Procedure: Single-step transepithelial PRK

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
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.

Key inclusion criteria (4 listed)

Mixed astigmatism (Plus sphere up to +4 diopters D and a minus cylinder up to -6 D).
Stable refraction.
Clear cornea.
Normal corneal tomography.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Femtosecond laser-assisted LASIKPatients 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.	Procedure or surgery	Femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) group
Single-step transepithelial PRKPatients 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.	Procedure or surgery	Single-step transepithelial photorefractive keratectomy (TransPRK) group

Primary outcome

Uncorrected distance visual acuity (UDVA)
Time frame: 24 months
Visual acuity measurement using Snellen's Acuity Chart converted to logMAR notation.
Corrected distance visual acuity (CDVA)
Time frame: 24 months
Corrected visual acuity measurement using Snellen's Acuity Chart and converted to logMAR notation.
Postoperative refraction
Time frame: 24 months
Manifest sphere and cylinder measured by Topcon Auto-Keratorefractometer

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Background: PubMed 33252566Kaluzny 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.
Background: PubMed 35167040Moshirfar 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Mixed Astigmatism, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uncorrected distance visual acuity (UDVA) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07481227, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.