Safety assessment of the IC-8 Apthera IOL after cataract treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to verify the post-market safety of the IC-8 Apthera intraocular lens (IOL) following treatment for posterior capsule opacification (PCO) using Nd:YAG laser capsulotomy. It is a prospective, multi-center, single-group study where participants who have previously received the IC-8 Apthera IOL and developed PCO will be monitored over 24 months. Participants will undergo approximately six study visits to assess their safety and outcomes after the treatment. The study follows a standardized technique for Nd:YAG laser capsulotomy, ensuring that all surgeons are adequately trained.

Why it matters

Who can join: the full rules

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

Where it's running

• Trinity Research Group, LLC
  Dothan, Alabama, United States Recruiting
• Feinerman Vision Center
  Newport Beach, California, United States Recruiting
• Argus Research Center
  Cape Coral, Florida, United States Recruiting
• Stephenson Eye Associates
  Venice, Florida, United States Recruiting
• Virdi Eye Clinic and Laser Vision Center
  Rock Island, Illinois, United States Recruiting
• Price Vision Group
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Study coordinator: Jennifer Laskowski
• Email: jennifer.laskowski@bausch.com
• Phone: 8183699137

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.