Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses

Innovative Medical

Status and phase

Unknown

Phase 4

Conditions

Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously

Treatments

Device: Nanoflex IOL

Study type

Interventional

Funder types

Industry

Identifiers

STARR2010-NF-IOL

Details and patient eligibility

About

The purpose of this study is to look at how well you see the Nanoflex Intraocular lens placed in your eye.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female patients at least 18 years of age.
Patients who have bilateral NanoFlex implantation at least 3 months previously.
No significant ocular pathology causing DCVA to be less than 20/25 or causing significant visual loss.
DCVA of 20/25 or better in both eyes.
Spherical equivalent in the dominant eye to be +/-.50 or less and in the non-dominant eye to be between-1.00 and -1.87.
Uncorrected VA in dominant eye 20/25 or better.

Exclusion criteria

History of ocular trauma or prior ocular surgery (minor ocular trauma is allowed such as small superficial corneal scar not effecting vision; some prior ocular surgery is allowable so long as it has not impacted visual acuity.
Amblyopia or strabismus, significant visual field loss, or posterior capsular opacifcation.
Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.).