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Cataract lens safety study aims to reduce Post-Surgery complications

NCT ID NCT06060041

Disease control Sponsor: Bausch & Lomb Incorporated 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study is checking the long-term safety of the IC-8 Apthera lens, which is implanted during cataract surgery. It focuses on a common complication called posterior capsule opacification (PCO), where the lens capsule becomes cloudy. Researchers will follow 435 people for 24 months to see how often additional laser treatments or other issues occur.

What this could mean

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

Active substance
IC-8 Apthera intraocular lens (a special lens implanted during cataract surgery)
What this could lead to
If successful, this study could confirm that the IC-8 Apthera lens is safe and effective for managing common post-surgery complications like posterior capsule opacification.
What could go wrong
This is a post-market safety study, not a test for a new cure. The lens is already approved, so the main risk is that unexpected complications may arise, but the study is designed to monitor them.

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 435 people

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

Started

Sep 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

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.

Who is studied

Potential study subjects will be recruited from patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification in the IC-8 Apthera IOL eye which requires treatment with Nd:YAG laser capsulotomy

Ages

22 years and older

Sex

Anyone

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: * 22 years of age or older, any race and any gender; * Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye * Able to comprehend and have signed a statement of informed consent; * Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits; * Clear intraocular media in both eyes; * Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation; * Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOL in the other eye in accordance with the directions for use (DFU) for each IOL. Exclusion Criteria: * Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye; * Irregular astigmatism in either eye; * History of retinal disease; * Active or recurrent anterior segment pathology; * Presence of ocular abnormalities; * Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment; * Previous corneal or intraocular surgery, except cataract surgery; * History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention; * Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study; * Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye; * Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study. * Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits

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Conditions

The condition(s) this trial relates to.

cataract presbyopia

As listed by the trial registrant

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

Cataract Posterior capsule opacification Presbyopia

How to take part

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

  1. The places running it

    14 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

  • Argus Research Center

    RECRUITING

    Cape Coral, Florida, 33909, United States

  • Berkeley Eye Center

    RECRUITING

    Sugar Land, Texas, 77478, United States

  • Eye Associates of New Jersey

    RECRUITING

    Dover, New Jersey, 07801, United States

  • Feinerman Vision Center

    RECRUITING

    Newport Beach, California, 92663, United States

  • Grene Vision Group

    RECRUITING

    Wichita, Kansas, 67206, United States

  • Northern New Jersey Eye Institute

    RECRUITING

    South Orange, New Jersey, 07079, United States

  • Oakland Eye

    RECRUITING

    Birmingham, Michigan, 48009, United States

  • Ophthalmic Partners, PC

    RECRUITING

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Price Vision Group

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Stephenson Eye Associates

    RECRUITING

    Venice, Florida, 34285, United States

  • Trinity Research Group, LLC

    RECRUITING

    Dothan, Alabama, 36301, United States

  • Utah Eye Centers

    RECRUITING

    Bountiful, Utah, 84010, United States

  • Vance Thompson Vision - Omaha

    RECRUITING

    Omaha, Nebraska, 68137, United States

  • Virdi Eye Clinic and Laser Vision Center

    RECRUITING

    Rock Island, Illinois, 61201, United States

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