Post-Market Clinical Investigation of the Clareon® IOL - Niet van toepassing

Alcon Laboratories0 sites16 target enrollmentTBD

Overview

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

October 20, 2021

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Alcon Laboratories

•1\. Adults, 22 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts
•2\. Able to comprehend and willing to sign an IRB/IEC approved statement of informed consent and complete all required post\-implantation visits
•3\. Planned small incision cataract removal surgery
•4\. Calculated lens power is within the available range (see Table 11\-1 for the available range of lens powers for this study)
•5\. Subjects for whom postoperative emmetropia is planned (defined as 0\.00± 0\.50 D spherical equivalent) in both eyes
•6\. Preoperative BCDVA worse than 0\.2 logMAR in at least one eye
•Potential post\-implantation visual acuity of 0\.2 logMAR or better in both eyes based on Investigator expert medical opinion

•1\. Subjects who may reasonably be expected to require an ocular surgical treatment at any time during the study (other than Nd:YAG capsulotomy)
•2\. Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of the subjects\* participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions)
•3\. Clinically significant corneal abnormalities including corneal dystrophy (eg, epithelial, stromal, or endothelial dystrophy), inflammation or edema per the Investigator\*s expert medical opinion
•(Note: Conditions including, but not limited to: keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or keratectasia should be excluded.)
•4\. Amblyopia
•5\. Previous corneal transplant
•6\. Extremely shallow anterior chamber (\* 2\.5 mm), not due to swollen cataract
•7\. Any recurrent severe anterior or posterior segment inflammation of any etiology, and or history of any disease producing an intraocular inflammatory reaction
•8\. Rubella, congenital, traumatic, or complicated cataracts
•9\. Ocular conditions where the need for a large capsulotomy can be anticipated (eg, diabetics, retinal detachment in the fellow eye, peripheral retinal pathology)