Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06992011

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Cong Jing

CONTACT

[email protected]

17269769976

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

SMILE

Procedure

Small Incision Lenticule Extraction

SMILE Xtra

Procedure

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

Primary outcomes

  1. visual acuity

    Time frame: 1 week, 1 month,3 months， 6 months, 12 months, 24 months, and 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Cong Jing

CONTACT

[email protected]

17269769976

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.