Active — Not RecruitingNot Applicable

Long-term Outcomes of SMILE PRO for High Astigmatism

Vietnam113 participantsStarted 2024-12-10

Plain-language summary

This prospective interventional study aims to evaluate the long-term refractive and visual quality outcomes of SMILE PRO surgery in patients with myopia and high astigmatism. Eligible participants undergo small incision lenticule extraction using the VisuMax 800 femtosecond laser. Postoperative assessments include uncorrected and corrected distance visual acuity, manifest refraction, astigmatic vector analysis, contrast sensitivity, and higher-order aberrations. Participants are followed for up to 12 months to assess refractive accuracy, stability, safety, and visual quality after surgery.

Who can participate

Age range18 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 18 to 40 years at the time of surgery * Diagnosis of myopia with high astigmatism eligible for SMILE PRO surgery * Stable refractive error prior to surgery * Adequate corneal thickness and topographic parameters suitable for SMILE PRO * Ability to understand the study procedures and provide written informed consent * Willingness and ability to attend scheduled postoperative follow-up visits Exclusion Criteria: * Presence of corneal ectatic disorders or suspicious corneal topography * History of previous ocular surgery or ocular trauma * Active ocular disease other than refractive error * Systemic diseases known to affect wound healing * Pregnancy or breastfeeding at the time of surgery

What they're measuring

Residual Refractive Astigmatism

Timeframe: 12 months postoperatively

Refractive Accuracy (Spherical Equivalent Error)

Timeframe: 12 months postoperatively

Trial details

NCT IDNCT07446751

SponsorHanoi Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10