Comparative Study of SMILE, ICL, and Wavelight Plus Alcon Technologies in Myopia Correction

Not Applicable

Recruiting

• Conditions: Myopia

• Registration Number: NCT06788418
• Lead Sponsor: Beijing Visionly Plus Eye Hospital

Brief Summary

Myopia is a prevalent refractive error with significant lifestyle impact. While traditional SMILE (Small Incision Lenticule Extraction) and ICL (Implantable Collamer Lens) surgeries are standard options, the advent of the Wavelight Plus Alcon system presents a promising new technique. This trial aims to evaluate the safety, efficacy, and patient satisfaction across these methods.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-20
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Adults aged 18-40 years
• Spherical equivalent of -1.00 to -10.00 D
• Stable refraction for at least 12 months
• Informed consent provided

Exclusion Criteria

• Other ocular pathologies
• Previous refractive surgery
• Pregnancy or nursing
• Autoimmune or connective tissue disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Vision at 12 months post-surgery	From the day of surgery through to the 12-month post-operative follow-up	Uncorrected distance vision (UDVA) at 12 months post-surgery

Secondary Outcome Measures

Name	Time	Method
Change in spherical equivalent at 12 months post-surgery	From the day of surgery through to the 12-month post-operative follow-up	Change of the spherical equivalent at 12 months post-surgery

Trial Locations

Locations (2)

Beijing New Vision Eye Hospital; 🇨🇳 Beijing, China

Beijing Visionly Plus Eye Hospital; 🇨🇳 Beijing, China