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

January 22, 2025 updated by: Beijing Visionly Plus Eye Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100020
        • Recruiting
        • Beijing New Vision Eye Hospital
        • Contact:
      • Beijing, China, 100027
        • Recruiting
        • Beijing Visionly Plus Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMILE Group
Standard Small Incision Lenticule Extraction (SMILE) procedure using VisuMax laser
Procedure: SMILE
Small Incision Lenticule Extraction surgery for myopia
Experimental: ICL group
Implantable Collamer Lens (ICL) implantation using the STAAR Surgical Visian ICL
Procedure: ICL
Implantable Collamer Lens surgery for myopia
Experimental: Wavelight Plus Alcon Group
Laser vision correction using the Wavelight Plus Alcon system
Procedure: Wavelight Plus Alcon system
Wavelight Plus Alcon system guided surgery for myopia
Other Names:
  • Small Incision Lenticule Extraction
  • Implantable Collamer Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vision at 12 months post-surgery
Time Frame: From the day of surgery through to the 12-month post-operative follow-up
Uncorrected distance vision (UDVA) at 12 months post-surgery
From the day of surgery through to the 12-month post-operative follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in spherical equivalent at 12 months post-surgery
Time Frame: From the day of surgery through to the 12-month post-operative follow-up
Change of the spherical equivalent at 12 months post-surgery
From the day of surgery through to the 12-month post-operative follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Visionly Plus Eye Hospital

Collaborators

High Myopia Control Alliance (HIMALAYA)
Beijing New Vision Eye Hospital
Shanghai Parkway Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Himalaya202501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only IPD used in the results publication will be shared

IPD Sharing Time Frame

January 2025-January 2027

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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