Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
NCT06973278

A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia

Led by Shanghai Zhongshan Hospital · Updated on 2025-05-15

200

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia

CONDITIONS

Official Title

A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 50 years
  • High myopia with a manifest refraction spherical equivalent (MRSE) between -6.00D and -10.00D and refractive changes within �b1 0.50D in the past two years
  • Best corrected distance visual acuity (CDVA) of 20/25 or better
  • Stable preoperative refractive status with myopia progression not exceeding 0.50D per year for at least 2 years
  • Predicted residual stromal thickness of at least 250bcm after lenticule removal
  • Discontinued soft contact lenses for at least 1 week, rigid contact lenses for at least 3 weeks, and orthokeratology lenses for at least 3 months
Not Eligible

You will not qualify if you...

  • Presence of other eye diseases such as keratoconus or suspected keratoconus, active keratoconjunctivitis, severe dry eye, glaucoma, retinal diseases including retinal tears or macular degeneration
  • Significant corneal scarring or cataracts that affect observation
  • Systemic diseases such as active systemic inflammation or connective tissue diseases that prevent participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhongshan Hospital

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

C

Cong Jing

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia | DecenTrialz