Recruiting

Nanoflex IOLs

Sponsor:

Innovative Medical

Code:

NCT01279122

Conditions

Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Nanoflex IOL

Study Details

Brief summary:

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

Conditions

Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously

Study ID

NCT01279122

Start date

Jan, 2011

Status verified date

Feb, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Nanoflex IOL

Interventions

Nanoflex IOL

Patients who were implanted with the Nanoflex IOL

Primary outcome measure

  • Uncorrected Near Visual Acuity [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Annie Christensen

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

Locations

Kenneth Lipstock

Recruiting

Richmond, Virginia, United States

Contacts

Annie Christensen

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

More Information

Sponsor

Innovative Medical

Last update posted

Feb 17, 2011

Last verified

Feb, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Innovative Medical on 2011-02-17.