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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai 10th People's Hospital

Shanghai, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

This study does not involve any interventions

Other

This study does not involve any interventions

Primary outcomes

Corneal Irregular Astigmatism

Time frame: preoperative and 6 years postoperatively

The 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 aberration

Time frame: preoperative and 6 years postoperatively

The 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.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Acronym: SMILE LASEK

Important dates

Study start: 2017
Primary completion: 2024
Study completion: 2024
First posted: Nov 5, 2024
Registry last updated: Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed