Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:24 AM
Study NCT ID:
NCT07446751
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Outcomes of SMILE PRO for High Astigmatism
Sponsor:
Hanoi Medical University
Organization:
Study Overview
Official Title:
Outcomes of SMILE PRO Surgery for the Correction of Myopia With High Astigmatism
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
This is a single-center, prospective interventional clinical study conducted to assess the long-term refractive and visual quality outcomes of SMILE PRO surgery for the correction of myopia with high astigmatism. The study is performed at Hong Son Eye Hospital, Vietnam, following approval from the Institutional Review Board of Hanoi Medical University. All participants provide written informed consent prior to enrollment.
Patients aged 18 to 40 years with stable myopic refractive error and high astigmatism are eligible for inclusion. All eyes undergo small incision lenticule extraction using the VisuMax 800 femtosecond laser according to a standardized surgical protocol. Manifest refraction, corneal topography, and ocular imaging are performed by experienced refractive technicians using standardized measurement protocols. All patients are examined preoperatively and postoperatively by an ophthalmologist, who reviews clinical findings and surgical eligibility. All SMILE PRO procedures are performed by the same ophthalmic surgeon to minimize variability related to surgical technique.
Outcome measures include uncorrected and corrected distance visual acuity, spherical equivalent refraction, residual refractive astigmatism, and astigmatic vector analysis based on the Alpins method. Visual quality outcomes are further evaluated using contrast sensitivity testing and wavefront aberrometry to assess higher-order aberrations. Intraoperative parameters, including centration and cyclotorsion, are recorded and analyzed for their potential association with postoperative refractive outcomes.
Postoperative examinations are performed at 1 week, 1 month, 3 months, 6 months, and 12 months after surgery. The primary objective of this study is to evaluate the long-term refractive accuracy, stability, and safety of SMILE PRO surgery in eyes with high astigmatism. Secondary objectives include the assessment of preoperative and intraoperative factors influencing postoperative visual and refractive outcomes.
Patients aged 18 to 40 years with stable myopic refractive error and high astigmatism are eligible for inclusion. All eyes undergo small incision lenticule extraction using the VisuMax 800 femtosecond laser according to a standardized surgical protocol. Manifest refraction, corneal topography, and ocular imaging are performed by experienced refractive technicians using standardized measurement protocols. All patients are examined preoperatively and postoperatively by an ophthalmologist, who reviews clinical findings and surgical eligibility. All SMILE PRO procedures are performed by the same ophthalmic surgeon to minimize variability related to surgical technique.
Outcome measures include uncorrected and corrected distance visual acuity, spherical equivalent refraction, residual refractive astigmatism, and astigmatic vector analysis based on the Alpins method. Visual quality outcomes are further evaluated using contrast sensitivity testing and wavefront aberrometry to assess higher-order aberrations. Intraoperative parameters, including centration and cyclotorsion, are recorded and analyzed for their potential association with postoperative refractive outcomes.
Postoperative examinations are performed at 1 week, 1 month, 3 months, 6 months, and 12 months after surgery. The primary objective of this study is to evaluate the long-term refractive accuracy, stability, and safety of SMILE PRO surgery in eyes with high astigmatism. Secondary objectives include the assessment of preoperative and intraoperative factors influencing postoperative visual and refractive outcomes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: