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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Innovative Medical.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01279122
First received: January 14, 2011
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously
Device: Nanoflex IOL
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses

Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Uncorrected Near Visual Acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Nanoflex IOL Device: Nanoflex IOL
Patients who were implanted with the Nanoflex IOL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279122

Contacts
Contact: Annie Christensen 951-653-5566 a.christensen@imedsonline.com

Locations
United States, Virginia
Kenneth Lipstock Recruiting
Richmond, Virginia, United States
Contact: Annie Christensen    951-653-5566    a.christensen@imedsonline.com   
Sponsors and Collaborators
Innovative Medical
  More Information

No publications provided

Responsible Party: Annie Christensen, IMEDS
ClinicalTrials.gov Identifier: NCT01279122     History of Changes
Other Study ID Numbers: STARR2010-NF-IOL
Study First Received: January 14, 2011
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 15, 2014