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Eye surgery showdown: device vs manual marking for sharper vision

NCT ID NCT07696468

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

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This trial tests whether a device called OcuLign, which automatically adjusts for eye rotation during SMILE surgery, corrects astigmatism better than the standard manual marking method. Adults aged 18 to 40 with stable myopia and astigmatism will have one eye treated with each method. The goal is to see which approach leaves less residual astigmatism three months after surgery.

What this could mean

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

Active substance
OcuLign-assisted cyclotorsion control (device procedure)
What this could lead to
If OcuLign proves better or equal to manual marking, it could become a standard tool for more precise astigmatism correction during SMILE surgery.
What could go wrong
This is a small, early-stage trial with only 52 participants. The improvement may be minimal, and results may not apply to all patients or surgeons.

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 52 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 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. Age range: 18 - 40 years old. Patients with myopic astigmatism and stable refractive status for \>= 1 year. 2. Normal corneal morphology in both eyes, with corneal thickness and other ocular parameters meeting the requirements for SMILE surgery. 3. Preoperative corrected distance visual acuity (CDVA) \>= 1.0 in both eyes. 4. Manifest refractive cylinder \>= 0.75 D in both eyes, with an interocular difference in absolute cylinder power \<= 1.00 D. 5. Both eyes can provide reliable preoperative upright-position image information required for astigmatic axis recognition, and are judged by the investigator to meet the requirements for OcuLign cyclotorsion recognition and axis alignment on the VISUMAX 800 platform. 6. Voluntary to undergo bilateral SMILE surgery on the VISUMAX 800 platform, understanding the random eye-assignment scheme and signing the informed consent form. Exclusion Criteria: 1. History of prior ocular surgery, significant ocular trauma, or presence of ocular diseases that may affect the safety of refractive surgery or the interpretation of study outcomes. 2. Irregular astigmatism or poor repeatability of bilateral astigmatism measurements, making reliable astigmatic axis analysis impossible. 3. Presence of strabismus, nystagmus, significant binocular vision abnormality, or any condition that may affect fixation or cooperation during examinations. 4. Severe systemic diseases that may affect ocular healing or surgical safety. 5. Females who are pregnant or lactating. 6. Inability to complete the required postoperative follow-up visits or questionnaire assessments.

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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

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  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong, 510060, China

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