Actively Recruiting
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
Eligibility Criteria
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
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
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
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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