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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Innovative Medical.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01279122
First Posted: January 19, 2011
Last Update Posted: February 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Innovative Medical
  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: None (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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Annie Christensen, IMEDS
ClinicalTrials.gov Identifier: NCT01279122     History of Changes
Other Study ID Numbers: STARR2010-NF-IOL
First Submitted: January 14, 2011
First Posted: January 19, 2011
Last Update Posted: February 17, 2011
Last Verified: February 2011