A Randomized Controlled Trial Comparing Clinical Effectiveness of SMILE Versus SMILE Xtra in Myopia

May 19, 2025 updated by: Shanghai Zhongshan Hospital
To evaluate and compare the clinical efficacy, biomechanical stability, and optical quality of SMILE and SMILE Xtra procedures in patients with myopia through a randomized controlled trial

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

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
    • Shanghai
      • Shanghai, Shanghai, China, 200032

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:

  1. Age 18-50 years
  2. MRSE (Manifest Refraction Spherical Equivalent) -6.00D to -10.00D with refractive changes within ±0.50D in past 2 years
  3. CDVA (Corrected Distance Visual Acuity) ≥ 20/25
  4. Myopia progression ≤ 0.50D/year for ≥2 years
  5. RST (Residual Stromal Thickness) ≥ 250μm after lenticule removal
  6. Contact lens discontinuation as per protocol

Exclusion Criteria:

  1. Other eye diseases (keratoconus, glaucoma, etc.)
  2. Corneal scarring, cataracts affecting observation
  3. Systemic diseases affecting surgery compliance
  4. Prior ocular surgeries
  5. Pregnancy, breastfeeding, or menstruation
  6. Drug allergies to surgical medication

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
Active Comparator: SMILE Group
Procedure: SMILE
Small Incision Lenticule Extraction
Experimental: SMILE Xtra Group
Procedure: SMILE Xtra
Small Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visual acuity
Time Frame: 1 week, 1 month,3 months， 6 months, 12 months, 24 months, and 36 months
1 week, 1 month,3 months， 6 months, 12 months, 24 months, and 36 months

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

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)

February 1, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

May 19, 2025

First Submitted That Met QC Criteria

May 19, 2025

First Posted (Actual)

May 28, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2024-267R-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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