NCT06973278 A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia
| NCT ID | NCT06973278 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2027-02-01 |
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 200 participants in total. It began in 2023-02-01 with a primary completion date of 2027-02-01.
⚠ 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 the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia
Eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 50 years. 2. High myopia with a manifest refraction spherical equivalent (MRSE) - 6.00D～-10.00D and refractive changes within ± 0.50D in the past two years; 3. Best corrected distance visual acuity (CDVA) ≥ 20/25. 4. Preoperative refractive status is stable (myopia progression not exceeding 0.50D per year for at least 2 years). 5. Predicted residual stromal thickness (RST) ≥ 250μm after lenticule removal. 6.Soft contact lenses discontinued for at least 1 week, rigid contact lenses for at least 3 weeks, and orthokeratology lenses for at least 3 months. Exclusion Criteria: 1. The presence of other eye diseases: keratoconus or suspected keratoconus, active keratoconjunctivitis, severe dry eye, glaucoma, retinal diseases such as retinal tears or macular degeneration, etc., 2. The presence of significant corneal scarring or cataracts affects observation. 3. Systemic diseases such as active systemic inflammation, connective tissue diseases, other conditions that prevent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06973278 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 NCT06973278 currently recruiting?
Yes, NCT06973278 is actively recruiting participants. Contact the research team at lucky_congjing@163.com for enrollment information.
Where is the NCT06973278 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06973278 clinical trial?
NCT06973278 is sponsored by Shanghai Zhongshan Hospital. The trial plans to enroll 200 participants.