Comparing the effectiveness of two treatments for myopia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhongshan Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Cong Jing
• Email: lucky_congjing@163.com
• Phone: 17269769976

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.