Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses
Phase 4
- Conditions
- Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously
- Interventions
- Device: Nanoflex IOL
- Registration Number
- NCT01279122
- Lead Sponsor
- Innovative Medical
- Brief Summary
The purpose of this study is to look at how well you see the Nanoflex Intraocular lens placed in your eye.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nanoflex IOL Nanoflex IOL -
- Primary Outcome Measures
Name Time Method Uncorrected Near Visual Acuity 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kenneth Lipstock
🇺🇸Richmond, Virginia, United States