RECRUITING

IC-8 Apthera IOL New Enrollment Post Approval Study

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Conditions

CataractPresbyopiaPosterior Capsule Opacification

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

IC-8 Apthera IOL New Enrollment Post Approval Study

Quick Facts

Study Start:2023-09-08
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06060041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 22 years of age or older, any race and any gender;
  2. * Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye
  3. * Able to comprehend and have signed a statement of informed consent;
  4. * Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
  5. * Clear intraocular media in both eyes;
  6. * Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation;
  7. * 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.
  1. * Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye;
  2. * Irregular astigmatism in either eye;
  3. * History of retinal disease;
  4. * Active or recurrent anterior segment pathology;
  5. * Presence of ocular abnormalities;
  6. * Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment;
  7. * Previous corneal or intraocular surgery, except cataract surgery;
  8. * History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
  9. * Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study;
  10. * 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;
  11. * Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study.
  12. * Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits

Contacts and Locations

Study Contact

Danni Fisher
CONTACT
716-329-1162
danni.fisher@bausch.com

Study Locations (Sites)

Trinity Research Group, LLC
Dothan, Alabama, 36301
United States
Feinerman Vision Center
Newport Beach, California, 92663
United States
Argus Research Center
Cape Coral, Florida, 33909
United States
Virdi Eye Clinic and Laser Vision Center
Rock Island, Illinois, 61201
United States
Price Vision Group
Indianapolis, Indiana, 46260
United States
Oakland Eye
Birmingham, Michigan, 48009
United States
Vance Thompson Vision - Omaha
Omaha, Nebraska, 68137
United States
Eye Associates of New Jersey
Dover, New Jersey, 07801
United States
Northern New Jersey Eye Institute
South Orange, New Jersey, 07079
United States
Ophthalmic Partners, PC
Bala-Cynwyd, Pennsylvania, 19004
United States
Berkeley Eye Center
Sugar Land, Texas, 77478
United States
Utah Eye Centers
Bountiful, Utah, 84010
United States

Collaborators and Investigators

Sponsor: AcuFocus, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-08
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2023-09-08
Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cataract
  • Presbyopia
  • Posterior Capsule Opacification