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

NCT06673992 | Completed

• 1 other identifier: Shanghai10HLi00001
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Corneal Irregular Astigmatism

  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.

  preoperative and 6 years postoperatively

• wavefront aberration

  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.

  preoperative and 6 years postoperatively

Interventions

This study does not involve any interventions OTHER

This study does not involve any interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with mild to moderate myopia or myopic astigmatism who underwent SMILE or LASEK between October 2017 and May 2018 were enrolled

You may qualify if:

• (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)

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: November 5, 2024
• Study Start: October 1, 2017
• Primary Completion: May 30, 2024
• Study Completion: October 1, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)