Comparing the effectiveness of two treatments for myopia

A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia

This study is testing which of two eye surgeries, SMILE or SMILE Xtra, works better for people aged 18 to 50 with high myopia to improve their vision and keep it stable over time.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06973278 on ClinicalTrials.gov

What this trial studies

This study evaluates the clinical efficacy and refractive stability of two surgical techniques, SMILE and SMILE Xtra, in patients suffering from myopia. Participants aged 18 to 50 with high myopia will be recruited, and their visual outcomes will be monitored post-surgery. The study aims to determine which technique offers better results in terms of vision correction and stability over time.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 18 to 50 with high myopia and stable refractive status.

Not a fit: Patients with other significant eye diseases or systemic conditions that could affect the outcomes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with improved options for treating myopia, leading to better visual outcomes.

How similar studies have performed: Previous studies have shown promising results with SMILE techniques, suggesting that this comparative approach could yield valuable insights.

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

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Cong Jing

Conditions Myopia