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

Beijing Visionly Plus Eye Hospital

Status: Enrolling

Conditions: Myopia

Treatments: Procedure: ICL; Procedure: Wavelight Plus Alcon system; Procedure: SMILE

Study type: Interventional

Funder types: Other

Identifiers

NCT06788418

Himalaya202501

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 3 patient groups

SMILE Group

Experimental group

Description:

Standard Small Incision Lenticule Extraction (SMILE) procedure using VisuMax laser

Treatment:

Procedure: SMILE

ICL group

Experimental group

Description:

Implantable Collamer Lens (ICL) implantation using the STAAR Surgical Visian ICL

Treatment:

Procedure: ICL

Wavelight Plus Alcon Group

Experimental group

Description:

Laser vision correction using the Wavelight Plus Alcon system

Treatment:

Procedure: Wavelight Plus Alcon system