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Status:

RECRUITING

IC-8 Apthera IOL New Enrollment Post Approval Study

Lead Sponsor:

Bausch & Lomb Incorporated

Conditions:

Cataract

Presbyopia

Eligibility:

All Genders

22+ years

Brief 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 IO...

Detailed 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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 8 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 30 2027

Estimated Enrollment :

435 Patients enrolled

Trial Details

Trial ID

NCT06060041

Start Date

September 8 2023

End Date

September 30 2027

Last Update

January 17 2025

Active Locations (12)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (12 locations)

1

Trinity Research Group, LLC

Dothan, Alabama, United States, 36301

2

Feinerman Vision Center

Newport Beach, California, United States, 92663

3

Argus Research Center

Cape Coral, Florida, United States, 33909

4

Virdi Eye Clinic and Laser Vision Center

Rock Island, Illinois, United States, 61201