NCT01279122

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2011

Enrollment Period

11 months

First QC Date

January 14, 2011

Last Update Submit

February 16, 2011

Conditions

Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously

Outcome Measures

Primary Outcomes (1)

  • Uncorrected Near Visual Acuity

    1 year

Study Arms (1)

Nanoflex IOL

NO INTERVENTION
Device: Nanoflex IOL

Interventions

Nanoflex IOLDEVICE

Patients who were implanted with the Nanoflex IOL

Nanoflex IOL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kenneth Lipstock

Richmond, Virginia, United States

RECRUITING

Central Study Contacts

Annie Christensen

CONTACT

951-653-5566a.christensen@imedsonline.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 17, 2011

Record last verified: 2011-02

Locations

US(1)