IC-8 Apthera IOL New Enrollment Post Approval Study

Recruiting at 15 trial locations

Overseen By Jennifer Laskowski

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AcuFocus, Inc.

Disqualifiers: Retinal disease, Ocular abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

435 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

You meet the eligibility criteria, being at least 22 years of age and not limited by race or gender.

You possess the availability, willingness, ability and adequate cognitive comprehension to participate in assessment activities and research visits.

Both of your eyes have a transparent internal medium.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PCO Treatment

Participants undergo Nd:YAG laser capsulotomy to treat posterior capsular opacification

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Approximately 6 visits (in-person)

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

AcuFocus, Inc.

Lead Sponsor

Trials

13

Recruited

2,700+

Bausch & Lomb Incorporated

Lead Sponsor

Trials

263

Recruited

59,400+

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University