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Long-term Outcomes of SMILE PRO for High Astigmatism

NCT07446751 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

  • High Astigmatism

Interventions

PROCEDURE

SMILE PRO surgery

Small incision lenticule extraction surgery performed using the VisuMax 800 femtosecond laser (SMILE PRO) for the correction of myopia with high astigmatism. The procedure is performed by a single experienced ophthalmic surgeon following a standardized surgical protocol.

Sponsors & Collaborators

  • Hanoi Medical University

    lead OTHER

Principal Investigators

  • Lan Tran, MD · Hanoi Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07446751 on ClinicalTrials.gov