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IC-8 Apthera IOL Study for Cataract and Presbyopia

This study is looking at the safety of the IC-8 Apthera IOL (intraocular lens) after a common procedure called Nd:YAG laser capsulotomy. This laser treatment is used for posterior capsule opacification (PCO), which can sometimes happen after cataract surgery. The study wants to see how well the IC-8 Apthera IOL performs after this laser treatment, specifically looking at how often additional laser treatments are needed and any related complications. You may be able to join if you are 22 or older, have the IC-8 Apthera IOL, and have developed PCO that needs laser treatment. The study aims to enroll 435 participants, but its current recruitment status is unclear.

Study design
This is an observational study involving one group of participants who have already received the IC-8 Apthera IOL and developed PCO. It is a multi-center study, meaning it takes place at several locations.
What's involved
You would have approximately 6 study visits over 24 months after your IC-8 Apthera IOL was implanted.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after their IC-8 Apthera IOL implantation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06060041

IC-8 Apthera IOL New Enrollment Post Approval Study

Recruiting
Not specifiedAges 22+Observational
Bausch & Lomb Incorporated
~435 participants
Updated 2026-01-12 on ClinicalTrials.gov

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment
Measured over 24 Months post IC-8 Apthera IOL Implantation
+7 more outcomes measured

Conditions

Cataract
Presbyopia
Posterior Capsule Opacification

Explore related trials

CataractPosterior Capsule OpacificationPresbyopia

Where it's being run

14 sites across 12 states
Florida2
New Jersey2
Alabama1
California1
Illinois1
Indiana1
Kansas1
Michigan1

Who to contact

Jennifer Laskowski
[email protected]
8183699137
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment24 Months post IC-8 Apthera IOL Implantation

    Rates of additional Nd:YAG laser treatments in the eye implanted with the IC-8 Apthera intraocular lens (IOL) beyond the initial Nd:YAG laser treatment will be assessed through 24 months post IC-8 Apthera IOL implantation

  • Nd:YAG laser treatment outcome and/or complications24 Months post IC-8 Apthera IOL Implantation

    Nd:YAG laser treatment outcomes and/or complications in the eye implanted with the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation.

  • IOL related assessments24 Months post IC-8 Apthera IOL implantation

    The appearance of the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation

  • Rates of Secondary Surgical Interventions (SSIs)24 Months post IC-8 Apthera IOL implantation

    Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes will be assessed through 24 months post IC-8 Apthera IOL implantation

  • Rates of other serious adverse events24 Months post IC-8 Apthera IOL implantation

    Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation

  • Rates of ocular adverse events24 Months post IC-8 Apthera IOL implantation

    Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation

  • Rates of subjective visual disturbances per the Quality of Vision (QoV) Questionnaire24 Months post IC-8 Apthera IOL implantation

    Subjective responses to the QoV Questionnaire that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes.

  • Rates of subjective visual disturbances per the Small Aperture Patient Questionnaire (SAPQ)24 Months post IC-8 Apthera IOL implantation

    Subjective responses to the Small Aperture Patient Questionnaire (SAPQ) that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes.