IC-8 Apthera IOL New Enrollment Post Approval Study

Bausch + Lomb

Status: Enrolling

Conditions: Cataract; Posterior Capsule Opacification; Presbyopia

Study type: Observational

Funder types: Industry

Identifiers

NCT06060041

SAIL-101-PAS2

Details and patient eligibility

About

The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.

Full description

Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.

Enrollment: 435 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

435 participants in 1 patient group

IC-8 Apthera intraocular lens (IOL) Group

Description:

Patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.