New laser surgery aims to sharpen vision for high astigmatism
NCT ID NCT07446751
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how well SMILE PRO laser surgery corrects high astigmatism in people with nearsightedness. 113 patients aged 18 to 40 will have the procedure and be followed for a year to check vision sharpness, stability, and safety. The goal is to see if this advanced laser technique provides lasting improvement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SMILE PRO laser surgery (small incision lenticule extraction using VisuMax 800 femtosecond laser)
- What this could lead to
- If successful, this could offer a safe and effective way to correct high astigmatism with better visual quality and fewer side effects than current methods.
- What could go wrong
- This is a single-center study with 113 participants, so results may not apply to everyone. Risks include incomplete correction, dry eyes, or rare complications like infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 113 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hong Son Eye Hospital
Hanoi, Hanoi, 100000, Vietnam
More trials for these conditions
Other studies related to the condition(s) this trial covers.