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

I

Innovative Medical

Status and phase

Unknown
Phase 4

Conditions

Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously

Treatments

Device: Nanoflex IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT01279122
STARR2010-NF-IOL

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Nanoflex IOL
No Intervention group
Treatment:
Device: Nanoflex IOL

Trial contacts and locations

0

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Central trial contact

Annie Christensen

Data sourced from clinicaltrials.gov

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