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

Recruiting now · Not applicable

Conditions studied: Myopia

In brief

To evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia

Key facts

Study ID

NCT06973278

Run by

Shanghai Zhongshan Hospital

People needed

200

Starts

2023-02-01

Expected to finish

2027-02-01

Last updated by the study team

2025-05-15

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 and 50 years.
• High myopia with a manifest refraction spherical equivalent (MRSE) - 6.00D～-10.00D and refractive changes within ± 0.50D in the past two years;
• Best corrected distance visual acuity (CDVA) ≥ 20/25.
• Preoperative refractive status is stable (myopia progression not exceeding 0.50D per year for at least 2 years).
• 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.

You may not qualify if…

• 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.,
• The presence of significant corneal scarring or cataracts affects observation.
• Systemic diseases such as active systemic inflammation, connective tissue diseases, other conditions that prevent

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.