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

NCT06992011 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-05-28

No results posted yet for this study

Summary

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

Conditions

  • Myopia

Interventions

PROCEDURE

SMILE

Small Incision Lenticule Extraction

PROCEDURE

SMILE Xtra

Small Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra)

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06992011 on ClinicalTrials.gov