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Evaluation of Corneal Irregular Astigmatism and Visual Quality Following Bilateral Sequential Small Incision Lenticule Extraction (SMILE) and Laser Subepithelial Keratomileusis (LASEK): A Six-Year Comparative Study

Evaluation of Corneal Irregular Astigmatism and Visual Quality Following Bilateral Sequential Small Incision Lenticule Extraction (SMILE) and Laser Subepithelial Keratomileusis (LASEK): A Six-Year Comparative Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06673992
Acronym
SMILE LASEK
Enrollment
71
Registered
2024-11-05
Start date
2017-10-01
Completion date
2024-10-01
Last updated
2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Brief summary

To compare the corneal spherical component (SC), regular astigmatism (RA), irregular astigmatism (IA, including Asymmetry and Irregularity) and visual quality six years after small incision lenticule extraction (SMILE) and laser subepithelial keratomileusis (LASEK) for mild to moderate myopia.

Interventions

This study does not involve any interventions

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* (1) patients aged over 18 years; (2) absence of corneal, ocular, or systemic diseases; (3) stable refractive diopter maintained for the past 2 years with a change of ± 0.50 diopter; (4) discontinuation of soft contact lens wear for at least 2 weeks and rigid contact lenses for at least 4 weeks prior to surgery; (5) preoperative manifest refraction spherical equivalent (MRSE) less than -6.00 diopter (D)

Exclusion criteria

A history of moderate to severe dry eye as well as any ocular or systemic disease that would contraindicate laser refractive surgery

Design outcomes

Primary

MeasureTime frameDescription
Corneal Irregular Astigmatismpreoperative and 6 years postoperativelyThe swept-source anterior segment OCT (CASIA SS-1000) was utilized to acquire corneal topography measurements. In the Corneal Map mode, 16 radial cross-sectional images (512 telecentric+A-scans) were obtained within a duration of 0.3 s for each measurement. The analysis program identified and digitized the anterior and posterior corneal surfaces to evaluate distributions of corneal power and corneal height for both the anterior and posterior corneal surfaces. The unit of Corneal Irregular Astigmatism is D.
wavefront aberrationpreoperative and 6 years postoperativelyThe wavefront aberrations were measured and analyzed for 6-mm pupil diameter with a Zywave aberrometer using a Hartmann-Shack sensor (Bausch & Lomb, US). The absolute Zernike coefficients including vertical trefoil, horizontal trefoil, vertical coma, horizontal coma, spherical aberration, and total higher-order aberrations (tHOAs) were examined. The unit of wavefront aberration is um.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026