Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
ID06788418

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

Led by Beijing Visionly Plus Eye Hospital · Updated on 2025-01-23

1000

Participants Needed

2

Research Sites

49 weeks

Total Duration

On this page

Sponsors

B

Beijing Visionly Plus Eye Hospital

Lead Sponsor

H

High Myopia Control Alliance (HIMALAYA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Myopia, a common vision condition affecting lifestyle, is the focus of this study comparing three surgical methods for correction. Researchers aim to assess the safety, effectiveness, and patient satisfaction of the Wavelight Plus Alcon system, Small Incision Lenticule Extraction (SMILE), and Implantable Collamer Lens (ICL) surgeries. These approaches represent different technologies used to treat myopia and are being evaluated to determine their relative benefits. Participants will undergo one of the three surgeries: Wavelight Plus Alcon system guided surgery, SMILE surgery, or ICL surgery. Each method involves a distinct procedure aimed at correcting myopia. The study does not specify additional treatment phases or extensions, focusing on the initial surgical intervention using these technologies. During the study, participants will be monitored for vision outcomes up to 12 months after surgery. Researchers will measure vision quality and safety throughout this period to evaluate each method's performance. Participant involvement includes follow-up visits for vision assessments to track progress and any adverse effects. The total participation time spans from surgery through a one-year postoperative follow-up.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-40 years
  • Spherical equivalent of -1.00 to -10.00 D
  • Stable refraction for at least 12 months
  • Informed consent provided
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Beijing New Vision Eye Hospital

Beijing, China, 100020

Actively Recruiting

2

Beijing Visionly Plus Eye Hospital

Beijing, China, 100027

Actively Recruiting

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Research Team

P

Peng ZHOU, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Frequently Asked Questions

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Published Research Related To This Trial