RECRUITINGOBSERVATIONAL
IC-8 Apthera IOL New Enrollment Post Approval Study
About 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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form;
- 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.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion 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.
Exclusion Criteria:
* 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
Locations (14)
Trinity Research Group, LLC
Dothan, Alabama, United States
Feinerman Vision Center
Newport Beach, California, United States
Argus Research Center
Cape Coral, Florida, United States
Stephenson Eye Associates
Venice, Florida, United States
Virdi Eye Clinic and Laser Vision Center
Rock Island, Illinois, United States
Price Vision Group
Indianapolis, Indiana, United States
Grene Vision Group
Wichita, Kansas, United States
Oakland Eye
Birmingham, Michigan, United States
Vance Thompson Vision - Omaha
Omaha, Nebraska, United States
Eye Associates of New Jersey
Dover, New Jersey, United States
Northern New Jersey Eye Institute
South Orange, New Jersey, United States
Ophthalmic Partners, PC
Bala-Cynwyd, Pennsylvania, United States
Berkeley Eye Center
Sugar Land, Texas, United States
Utah Eye Centers
Bountiful, Utah, United States