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Laser eye surgery gets a precision upgrade: new trial tests alignment fix for sharper vision

NCT ID NCT07512115

Symptom relief Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This trial tests whether a small adjustment during SMILE laser surgery—compensating for the eye's natural offset (kappa angle)—can improve visual quality for people with nearsightedness. About 224 participants will receive either standard SMILE or SMILE with this compensation. Researchers will measure visual distortions and clarity over six months to see if the adjustment makes a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SMILE laser surgery with kappa-angle compensation
What this could lead to
If successful, this could lead to better visual quality and fewer visual distortions after laser eye surgery for people with myopia.
What could go wrong
This is a small, early-stage trial with 224 participants, so results may not apply to everyone. The improvement may be minor and not noticeable in daily life.

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

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

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients aged 18 to 40 years with myopia or myopic astigmatism and stable refraction for \>=1 year, whose refractive errors fall within the treatable range of and meet the indications for SMILE surgery. 2. Normal corneal morphology and corneal thickness meeting surgical requirements. 3. Preoperative corrected distance visual acuity (CDVA) \>= 1.0. 4. Preoperative synthetic Kappa angle offset measured \>= 0.10 mm and \< 0.20 mm. 5. Voluntarily agree to undergo SMILE surgery on the VISUMAX 800 platform, understand the randomization scheme, and provide signed informed consent. Exclusion Criteria: 1. History of prior ocular surgery, significant ocular trauma, or presence of corneal or ocular diseases that may affect the safety of refractive surgery. 2. Severe systemic diseases that may affect ocular healing or surgical safety. 3. Females who are pregnant or lactating. 4. Inability to cooperate as required to complete the procedure or follow-up visits.

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Conditions

The condition(s) this trial relates to.

myopia refractive error

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myopia Refractive ametropia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Zhongshan Ophthalmic Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

More trials for these conditions

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