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

• 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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-16
• Last Update Posted: 2011-02-17
• Primary Completion: 2011-12
• Study Completion: 2011-12

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

Primary Outcome Measures

Name	Time	Method
Uncorrected Near Visual Acuity	1 year

Trial Locations

Locations (1)

Kenneth Lipstock; 🇺🇸 Richmond, Virginia, United States