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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness and refractive stability of two procedures, SMILE and SMILE Xtra, in people with myopia. The study compares Small Incision Lenticule Extraction SMILE alone versus SMILE combined with Corneal Cross-linking SMILE Xtra to see which approach better manages myopia. This research is being conducted by Shanghai Zhongshan Hospital and focuses on adults aged 18 to 50 years with high myopia. Participants will be assigned to receive either the SMILE procedure or the SMILE Xtra procedure. SMILE involves the removal of a small lenticule from the cornea, while SMILE Xtra adds corneal cross-linking to this process to potentially improve stability. The study is non-randomized and does not use masking. Treatments are performed as procedures, and patients will be followed over time to assess outcomes. During the study, participants will have their visual acuity measured at multiple time points 1 week, 1 month, 6 months, 12 months, 24 months, and 36 months after the procedure. Researchers will monitor how well vision is corrected and how stable the refractive changes remain. The total duration of follow-up is three years, allowing careful assessment of long-term results. Safety and vision quality will be closely observed throughout the study period.
CONDITIONS
Brief 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
- 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 250 micrometers after lenticule removal
- Discontinuation of soft contact lenses for at least 1 week, rigid 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 including active systemic inflammation and connective tissue diseases that prevent participation
Research Team
C
Cong Jing
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here