IC-8 Apthera IOL New Enrollment Post Approval Study

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.

Conditions

Cataract, Presbyopia, Posterior Capsule Opacification

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Study Overview

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Study Details

Study overview

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.

IC-8 Apthera IOL New Enrollment Post Approval Study

IC-8 Apthera IOL New Enrollment Post Approval Study

Condition
Cataract
Intervention / Treatment

-

Contacts and Locations

Dothan

Trinity Research Group, LLC, Dothan, Alabama, United States, 36301

Newport Beach

Feinerman Vision Center, Newport Beach, California, United States, 92663

Cape Coral

Argus Research Center, Cape Coral, Florida, United States, 33909

Rock Island

Virdi Eye Clinic and Laser Vision Center, Rock Island, Illinois, United States, 61201

Indianapolis

Price Vision Group, Indianapolis, Indiana, United States, 46260

Birmingham

Oakland Eye, Birmingham, Michigan, United States, 48009

Omaha

Vance Thompson Vision - Omaha, Omaha, Nebraska, United States, 68137

Dover

Eye Associates of New Jersey, Dover, New Jersey, United States, 07801

South Orange

Northern New Jersey Eye Institute, South Orange, New Jersey, United States, 07079

Bala-Cynwyd

Ophthalmic Partners, PC, Bala-Cynwyd, Pennsylvania, United States, 19004

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AcuFocus, Inc.,

Study Record Dates

2027-09-30