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Can skipping the gel make lens implant surgery safer?

NCT ID NCT03059043

Disease control Sponsor: Wenzhou Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study tests a new way to implant a corrective lens inside the eye for people with high myopia (severe nearsightedness). The new method uses a saltwater solution instead of a gel to keep the eye stable during surgery. Half of the participants will have the new method in one eye and the standard gel method in the other, allowing a direct comparison. The goal is to see if the new method is as safe and effective, with a focus on eye pressure and visual outcomes.

What this could mean

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

Active substance
viscoelastic-free implantation system (device)
What this could lead to
If successful, this could offer a safer, simpler way to implant ICL lenses for high myopia, potentially reducing post-surgery eye pressure spikes.
What could go wrong
This is a small pilot study, so results may not be conclusive. The new method might not be as safe or effective as the standard approach, and there are risks like elevated eye pressure or corneal damage.

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 60 people

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

Started

Nov 2018

Expected to finish

Jun 2028

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 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Documented stable refraction for at least 1 year(within 0.5D) * Best spectacle-corrected visual acuity (BCVA) of 20/40 or better * Clear central cornea * -0.5D to -18.0D of myopic refractive error * Normal anterior chamber depth at least 2.8 mm to endothelium * Endothelial cell density (ECD) more than 2000 cell/mm2 * Pupil diameter smaller than 7.0 mm under mesopic condition * Discontinued 3 weeks for hard contact lens and 1 week for soft contact lens wear Exclusion Criteria: * Preexisting ocular diseases or conditions other than myopia, evidence of progressive or acute ocular disease * Evidence of connective tissue disease or other systemic diseases that may confound the results of the study; * Narrow angle of anterior chamber * Pregnant, lactating, or planning to become pregnant during the course of the trial

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Conditions

The condition(s) this trial relates to.

degenerative myopia myopia

As listed by the trial registrant

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

Myopia

How to take part

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

  1. The places running it

    5 sites. 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

  • Guangdong General Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510000, China

  • Hunan Provincial People's Hospital

    NOT_YET_RECRUITING

    Changsha, Hunan, 410000, China

  • Peking Union Medical College Hospital

    NOT_YET_RECRUITING

    Beijing, 100000, China

  • Shanghai Ninth People's Hospital

    NOT_YET_RECRUITING

    Shanghai, 200000, China

  • The Eye Hispital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

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