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New gel keeps eyes safe during cataract surgery, study finds

NCT ID NCT07343973

Disease control Sponsor: i+Med S.Coop. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested OpHLINE, a clear gel used during cataract surgery to keep the eye stable and protect delicate cells. Researchers followed 69 adults who had cataract surgery with the gel. The gel worked well in most cases, and serious complications were rare. The results support OpHLINE as a reliable tool for surgeons.

What this could mean

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

Active substance
OpHLINE ophthalmic viscosurgical device (sodium hyaluronate gel)
What this could lead to
If successful, this study confirms that OpHLINE is a safe and effective tool for cataract surgery, helping surgeons protect the eye during the procedure.
What could go wrong
This is a small, completed post-market study with no control group, so results may not apply to all patients or surgical settings. The gel is already approved, so no major new breakthrough is expected.

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

69 people

The number who actually took part.

Started

Mar 2021

Finished

Sep 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: * Adults aged 18 years or older scheduled for cataract extraction by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye (operative eye). * The non-operative eye must be functional, as assessed by the investigator. Exclusion Criteria: * Ocular hypertension (IOP ≥ 22 mmHg). * Corneal endothelial damage (cell count \< 2000 cells/mm²). * History of chronic or recurrent ocular inflammatory disease. * Chronic or recurrent uveitis. * Acute ocular disease. * Internal or external ocular infection. * Glaucoma or proliferative diabetic retinopathy. * Previous ocular trauma before surgery. * Congenital ocular anomalies or iris atrophy. * Any other ocular pathology or physiological condition that could be worsened by cataract surgery. * Previous ocular surgery.

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Conditions

The condition(s) this trial relates to.

cataract

As listed by the trial registrant

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

Cataract surgery

Contacts and locations

Locations

  • Araba University Hospital

    Vitoria-Gasteiz, Álava, 01009, Spain

  • Basurto University Hospital

    Bilbao, Bizkaia, 48013, Spain

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