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Tiny lens left behind may affect vision after laser eye surgery

NCT ID NCT06806085

Knowledge-focused Sponsor: Second Affiliated Hospital of Nanchang 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at why some people develop higher-order vision distortions after SMILE laser eye surgery when a tiny piece of the removed lens is left in the eye. Researchers will measure changes in the eye's surface shape before and after surgery in 33 people. The goal is to understand what factors cause these distortions, which could help improve future surgeries.

What this could mean

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

Active substance
small incision lenticule extraction (SMILE) surgery with lenticule retained
What this could lead to
If successful, this could help surgeons refine SMILE procedures to reduce visual distortions for future patients.
What could go wrong
This is a small, early observational study with only 33 participants, so results may not apply to everyone. It does not test a new treatment.

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.

Participants

About 33 people

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

Started

Oct 2024

Expected to finish

Oct 2026

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.

Who is studied

Each subject must have complete surgical video recordings and medical records.

Ages

18 to 45 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 ≥ 18 years, gender unrestricted; 2. Equivalent spherical refraction ≤ -10.0D, corrected distance visual acuity ≥ 1.0, myopia stable for ≥ 2 years, and no contact lens wear for at least 2 weeks; 3. The patient voluntarily participates in this study, signs the informed consent form, and agrees to follow up according to the study plan; 4. Predicted postoperative residual corneal stromal thickness ≥ 280 micrometers. Exclusion Criteria: 1. Subclinical keratoconus, keratoconus, moderate to severe corneal opacities or scars, and other ocular conditions; 2. Diabetes, keloid-prone constitution, autoimmune and connective tissue diseases, etc.; 3. Severe mental disorders such as generalized anxiety disorder, panic disorder, depression, schizophrenia, and bipolar disorder; inability to cooperate with physicians; 4. Refusal to participate in the study.

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Conditions

The condition(s) this trial relates to.

Smiling

As listed by the trial registrant

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

Corneal higher-order wavefront aberrations Residual lenticule Small-incision lenticule extraction (smile) surgery

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

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.