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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nanoflex IOL

Group Type NO_INTERVENTION

Nanoflex IOL

Intervention Type DEVICE

Patients who were implanted with the Nanoflex IOL

Interventions

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Nanoflex IOL

Patients who were implanted with the Nanoflex IOL

Intervention Type DEVICE

Eligibility Criteria

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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.).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes