NCT06992011 A Randomized Controlled Trial Comparing Clinical Effectiveness of SMILE Versus SMILE Xtra in Myopia
| NCT ID | NCT06992011 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-02-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. Age 18-50 years 2. MRSE (Manifest Refraction Spherical Equivalent) -6.00D to -10.00D with refractive changes within ±0.50D in past 2 years 3. CDVA (Corrected Distance Visual Acuity) ≥ 20/25 4. Myopia progression ≤ 0.50D/year for ≥2 years 5. RST (Residual Stromal Thickness) ≥ 250μm after lenticule removal 6. Contact lens discontinuation as per protocol Exclusion Criteria: 1. Other eye diseases (keratoconus, glaucoma, etc.) 2. Corneal scarring, cataracts affecting observation 3. Systemic diseases affecting surgery compliance 4. Prior ocular surgeries 5. Pregnancy, breastfeeding, or menstruation 6. Drug allergies to surgical medication
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06992011 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06992011 currently recruiting?
Yes, NCT06992011 is actively recruiting participants. Contact the research team at lucky_congjing@163.com for enrollment information.
Where is the NCT06992011 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06992011 clinical trial?
NCT06992011 is sponsored by Shanghai Zhongshan Hospital. The trial plans to enroll 300 participants.