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

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

Study Overview

• Status: Unknown
• Conditions: Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously
• Intervention / Treatment: Device: Nanoflex IOL

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States
      • Recruiting
      • Kenneth Lipstock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Nanoflex IOL	Device: Nanoflex IOL; Patients who were implanted with the Nanoflex IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Uncorrected Near Visual Acuity	1 year

Collaborators and Investigators

• Sponsor: Innovative Medical

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: January 14, 2011
• First Submitted That Met QC Criteria: January 18, 2011
• First Posted (Estimate): January 19, 2011

Study Record Updates

• Last Update Posted (Estimate): February 17, 2011
• Last Update Submitted That Met QC Criteria: February 16, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: STARR2010-NF-IOL