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NCT Number: NCT06973278

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

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

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Cong Jing

CONTACT

[email protected]

17269769976

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

SMILE

Procedure

Small Incision Lenticule Extraction

SMILE Xtra

Procedure

Small Incision Lenticule Extraction combined with Corneal Cross-linking (SMILE Xtra)

Primary outcomes

  1. visual acuity

    Time frame: 1 week, 1 month, 6 months, 12 months,24 months and 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Cong Jing

CONTACT

[email protected]

17269769976

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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