IC-8 Apthera IOL for Posterior Capsule Opacification

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?

This trial aims to ensure the safety of the IC-8 Apthera IOL, an eye implant used to treat posterior capsular opacification (PCO), a common vision problem after cataract surgery. It focuses on individuals who have already received the IC-8 Apthera IOL in one eye and experience cloudiness requiring treatment. Suitable candidates are those with this specific implant who have clear vision in both eyes but now need PCO treatment in the implanted eye. Participants must also be willing and able to attend regular study visits. As a Phase 4 trial, this research helps to understand how the already FDA-approved and effective treatment benefits more patients, offering participants a chance to contribute to broader patient care improvements.

What is the safety track record for the IC-8 Apthera IOL?

Research shows that the IC-8 Apthera IOL, a lens used in cataract surgery, is safe and effective. Studies have examined its use, particularly for patients who develop posterior capsular opacification (PCO) after receiving the lens. PCO can cloud vision.

The FDA has approved this lens for cataract patients, confirming its safety based on past research. In earlier studies, most patients who received the IC-8 Apthera IOL tolerated it well. While side effects can occur, the overall results have been positive. The lens has provided good vision, even for those with slight eye shape differences like astigmatism.

In summary, research supports the IC-8 Apthera IOL as a safe and effective option for patients after cataract surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The IC-8 Apthera IOL is unique because it offers a new approach for people with cataracts and presbyopia, a condition where near vision becomes blurry with age. Unlike standard monofocal or multifocal intraocular lenses, which either focus at a single distance or split light for different distances, the IC-8 Apthera uses a small aperture design. This design aims to improve depth of focus and reduce dependency on glasses by mimicking the natural "pinhole effect," enhancing vision across various distances. Researchers are excited because this innovative mechanism could provide clearer, more versatile vision correction than current lens options.

What evidence suggests that the IC-8 Apthera IOL is effective for posterior capsule opacification?

Research has shown that the IC-8 Apthera IOL lens effectively improves vision. Studies found that 88.2% of people achieved clear distance vision of 20/32 or better after using this lens. It also enhances intermediate vision, helping with clarity at arm's length. The lens is designed to assist with presbyopia, which is difficulty focusing on close objects, especially when other treatments might not work as well. Overall, clinical studies and real-world evidence support the IC-8 Apthera IOL as a safe and effective way to improve vision after cataract surgery. ^{2 4 5 6 7}

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

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/P210005C.pdf

AcuFocus Overall, the results of the clinical study demonstrate that at 12 Months post implantation, the IC-8. IOL is safe and effective for the visual correction of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9409955/

Small Aperture IC-8 Extended-Depth-of-Focus Intraocular ... They reported that 88.2% and 11.7% of eyes achieved a UDVA and UIVA of 20/32 or higher, respectively. In addition, no eyes exceeded a UNVA of 20 ...

3. ctv.veeva.com ctv.veeva.com/study/ic-8-apthera-iol-new-enrollment-post-approval-study

IC-8 Apthera IOL New Enrollment Post Approval Study 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 ( ...

4. specialty.vision specialty.vision/article/apthera-ic-8-iol-innovative-solution-for-cataract-surgery/

Apthera IC-8 IOL: Innovative Solution for Cataract Surgery Clinical studies and real-world results provide strong evidence for the visual outcomes, safety, and patient satisfaction with the Apthera IC-8 lens. This data ...

5. bauschsurgical.com bauschsurgical.com/resources/peer-opinions/ic-8-apthera-excellent-outcomes-for-patients-with-low-amounts-of-astigmatism/

IC-8® Apthera™: Excellent Outcomes for Patients With Low ... “The Apthera IOL allows surgeons to be successful in patients who are looking for presbyopia correction and patients for whom other technologies are just not a ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/P210005B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Subjects enrolled will be those that have developed PCO following IC-8® Apthera™ IOL implantation that requires treatment of posterior capsular opacification.

7. bauschsurgical.com bauschsurgical.com/cataract/ic-8-apthera-iol/

IC-8® Apthera™ IOL Intuitive Integration · Of all cataract patients present with 1.5D of corneal astigmatism or less · Consistent results, even with astigmatism.