Comparing Efficacy and Corneal Biomechanics Between KLEx and KLEx Xtra in High Myopia: A 1-Year Prospective Randomized Study.
Jing Cong, Xueqi Lin, Jiayue Yuan...
https://pubmed.ncbi.nlm.nih.gov/41781518Actively Recruiting
Phase Not Applicable
Age: 18Years - 50Years
All Genders
ID06992011
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized controlled trial to compare the clinical effectiveness, biomechanical stability, and optical quality of two procedures for treating myopia: Small Incision Lenticule Extraction (SMILE) and SMILE combined with Corneal Cross-linking (SMILE Xtra). The study aims to understand which procedure better addresses myopia in patients aged 18 to 50 years. This research is sponsored by Shanghai Zhongshan Hospital and focuses on evaluating visual outcomes over a long period. Participants will be randomly assigned to receive either the SMILE procedure or the SMILE Xtra procedure. These are both eye surgeries designed to correct myopia, with SMILE Xtra including an additional cross-linking step intended to improve corneal stability. The study will follow patients for up to 36 months after treatment to assess how well their vision improves and how stable the results remain over time. Throughout the study, participants will have their visual acuity measured at multiple timepoints: 1 week, 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months after surgery. This will help researchers monitor the effectiveness and safety of each procedure. Patients will also be evaluated for any complications or changes in eye health. The total participation duration can last up to three years, with regular follow-up visits to assess and compare outcomes.
CONDITIONS
Brief Title
A Randomized Controlled Trial Comparing Clinical Effectiveness of SMILE Versus SMILE Xtra in Myopia
Who Can Participate
Age: 18Years - 50Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 50 years
- Manifest Refraction Spherical Equivalent between -6.00D and -10.00D with refractive changes within �b10.50D in past 2 years
- Corrected Distance Visual Acuity of 20/25 or better
- Myopia progression of 0.50D or less per year for at least 2 years
- Residual Stromal Thickness of 250 micrometers or more after lenticule removal
- Discontinued contact lens use as required by the 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 that affect ability to comply with surgery
- Previous eye surgeries
- Currently pregnant, breastfeeding, or menstruating
- Allergies to medications used in surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery plus immediate recovery period
Participants undergo either SMILE or SMILE Xtra surgical procedures to correct myopia.
1 surgery visit and 1 post-operative visit
Post-operative Follow-up
Duration - Up to 36 months
Participants have follow-up visits to monitor visual acuity and recovery after surgery.
Visits at 1 week, 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
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
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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