Long-term Outcomes of SMILE PRO for High Astigmatism

NCT07446751 | Active Not Recruiting

• 1 other identifier: #HMUIRB1649#
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SMILE PRO; High astigmatism; Small incision lenticule extraction; Astigmatic vector analysis; Cyclotorsion; Higher-order aberrations; Contrast sensitivity

Outcome Measures

Primary Outcomes (2)

• Residual Refractive Astigmatism

  Residual refractive astigmatism was measured using manifest refraction and analyzed with astigmatic vector analysis based on the Alpins method.

  12 months postoperatively

• Refractive Accuracy (Spherical Equivalent Error)

  Refractive accuracy was assessed using manifest refraction spherical equivalent (SEQ) after SMILE PRO surgery.

  12 months postoperatively

Secondary Outcomes (13)

• Refractive Stability Over Time (Spherical Equivalent)

  1 week, 1 month, 3 months, 6 months, and 12 months postoperatively

• Refractive Cylinder Over Time

  1 week, 1 month, 3 months, 6 months, and 12 months postoperatively

• Uncorrected Distance Visual Acuity (UDVA)

  1 week, 1 month, 3 months, 6 months, and 12 months postoperatively

• Corrected Distance Visual Acuity (CDVA)

  1 month, 3 months, 6 months, and 12 months postoperatively

• Surgically Induced Astigmatism (SIA)

  3 months and 12 months postoperatively

Study Arms (1)

SMILE PRO surgery

EXPERIMENTAL

Participants with myopia and high astigmatism undergoing small incision lenticule extraction using the SMILE PRO surgery.

Procedure: SMILE PRO surgery

Interventions

SMILE PRO surgery PROCEDURE

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.

SMILE PRO surgery

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hong Son Eye Hospital

Hanoi, Hanoi, 100000, Vietnam

Location

Related Publications (4)

• Reinstein DZ, Archer TJ, Potter JG, Gupta R, Wiltfang R. Refractive and Visual Outcomes of SMILE for Compound Myopic Astigmatism With the VISUMAX 800. J Refract Surg. 2023 May;39(5):294-301. doi: 10.3928/1081597X-20230301-02. Epub 2023 May 1.

  PMID: 37162399 BACKGROUND

• Pedersen IB, Ivarsen A, Hjortdal J. Changes in Astigmatism, Densitometry, and Aberrations After SMILE for Low to High Myopic Astigmatism: A 12-Month Prospective Study. J Refract Surg. 2017 Jan 1;33(1):11-17. doi: 10.3928/1081597X-20161006-04.

  PMID: 28068441 BACKGROUND

• Chan TCY, Wang Y, Ng ALK, Zhang J, Yu MCY, Jhanji V, Cheng GPM. Vector analysis of high (>/=3 diopters) astigmatism correction using small-incision lenticule extraction and laser in situ keratomileusis. J Cataract Refract Surg. 2018 Jul;44(7):802-810. doi: 10.1016/j.jcrs.2018.04.038. Epub 2018 Jun 13.

  PMID: 29909252 BACKGROUND

• Zhou J, Gu W, Gao Y, He G, Zhang F. Vector analysis of high astigmatism (>/= 2.0 diopters) correction after small-incision lenticule extraction with stringent head positioning and femtosecond laser-assisted laser in situ keratomileusis with compensation of cyclotorsion. BMC Ophthalmol. 2022 Apr 5;22(1):157. doi: 10.1186/s12886-022-02384-0.

  PMID: 35382779 BACKGROUND

Study Officials

• Lan Tran, MD

  Hanoi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 3, 2026
• Study Start: December 10, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 12 months after publication of the primary results and will remain available for 5 years.
• Access Criteria: Data will be shared with qualified researchers who submit a methodologically sound proposal. Requests will be reviewed by the study investigators, and data access will be granted after approval of the proposal and signing of a data use agreement.

Locations

VN (1)