Actively Recruiting
A Randomized Controlled Trial Comparing Clinical Effectiveness of SMILE Versus SMILE Xtra in Myopia
Led by Shanghai Zhongshan Hospital · Updated on 2025-05-28
300
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Randomized Controlled Trial Comparing Clinical Effectiveness of SMILE Versus SMILE Xtra in Myopia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 50 years
- Manifest Refraction Spherical Equivalent (MRSE) between -6.00D and -10.00D with refractive changes within �b10.50D in the past 2 years
- Corrected Distance Visual Acuity (CDVA) of 20/25 or better
- Myopia progression of 0.50D or less per year for 2 or more years
- Residual Stromal Thickness (RST) of 250bc or more after lenticule removal
- Contact lens use discontinued as per protocol
You will not qualify if you...
- Presence of other eye diseases such as keratoconus or glaucoma
- Corneal scarring or cataracts that affect observation
- Systemic diseases affecting surgery compliance
- Prior eye surgeries
- Pregnancy, breastfeeding, or menstruation
- Allergies to drugs used in surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
C
Cong Jing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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