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Clinical Trials in the USA / NCT06060041
Recruiting Observational

IC-8 Apthera IOL New Enrollment Post Approval Study

NCT06060041 · tracked via the Priya Life Science USA tracker
Sponsor
Bausch & Lomb Incorporated
Phase
Observational
Started
2023-09-08
Last updated
2026-01-12

Condition(s) studied

CataractPresbyopiaPosterior Capsule Opacification

Study summary

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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment — 24 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 complications — 24 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 assessments — 24 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 events — 24 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 events — 24 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) Questionnaire — 24 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.

Trial sites (14)

FacilityCityRegionStatus
Trinity Research Group, LLC Dothan Alabama Recruiting
Feinerman Vision Center Newport Beach California Recruiting
Argus Research Center Cape Coral Florida Recruiting
Stephenson Eye Associates Venice Florida Recruiting
Virdi Eye Clinic and Laser Vision Center Rock Island Illinois Recruiting
Price Vision Group Indianapolis Indiana Recruiting
Grene Vision Group Wichita Kansas Recruiting
Oakland Eye Birmingham Michigan Recruiting
Vance Thompson Vision - Omaha Omaha Nebraska Recruiting
Eye Associates of New Jersey Dover New Jersey Recruiting
Northern New Jersey Eye Institute South Orange New Jersey Recruiting
Ophthalmic Partners, PC Bala-Cynwyd Pennsylvania Recruiting
Berkeley Eye Center Sugar Land Texas Recruiting
Utah Eye Centers Bountiful Utah Recruiting

More Bausch & Lomb Incorporated trials in the USA

A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months. Active, not recruiting
A Study to Assess Safety, Tolerability, and Pharmacokinetics of Ascending Concentrations of Topical Ocular BL1332 in Healthy Volunteers Active, not recruiting

Other trials for the same condition

Capella Scientia Development Study Recruiting
Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution Active, not recruiting
The VIS Opti-K Low Vision Aid Device Provides Vision Improvement. Starting soon
North American Comfilcon A Clinical Study Recruiting
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06060041 on ClinicalTrials.gov ↗ ← All trials in the USA