The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity

Last updated: August 2, 2016
Sponsor: Physician Recommended Nutriceuticals
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Eye Disease

Eye Disorders/infections

Vision Loss

Treatment

N/A

Clinical Study ID

NCT02260973
PRN 20145
  • Ages 30-90
  • All Genders

Study Summary

This is a randomized, masked, placebo controlled study to assess the effect on visual acuity, if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presence of nuclear or cortical lens opacities in one/both eyes

  • Physician diagnosis of age related cataract

  • Good overall physical constitution

  • All participants must be follow the same regimen for surgery related medications, bothpre and post surgery. (Antibiotic, NSAID and Steroid eye drops)

Exclusion

Exclusion Criteria:

  • Subjects requiring Premium IOLs/multifocal implants

  • Advanced cataract

  • Severe Age-Related Macular Degeneration Presence or history of Glaucoma

  • Presence or history of Diabetes Mellitus

  • Any Retinal pathology - retinal detachment, retinitis pigmentosa, diabeticretinopathy, etc

  • Vision loss due to Central retinal artery occlusion or Central retinal vein occlusion

  • Vision loss due to presence of large pituitary tumors or aneurysms

  • Vision loss due to optic tract lesions

  • Vision loss due to bleeding into aqueous or vitreous chamber

  • Vision loss due to drug toxicity: Amiodarone, anti-tuberculosis drugs,hydroxychloroquine, tamoxifen

  • Major cardiovascular or cerebral events in the past 12 months

  • Allergy to fish oil or safflower oil

  • Pregnancy or lactation at any time during the study

  • Newly started or increased the dose of chronic systemic medication known to affecttear production including, but not limited to antihistamines, antidepressants,diuretics, corticosteroids or immunomodulators within 30 days of Screening or at anytime during the study

  • Participation in any other study involving an investigational drug or device withinthe past 30 days

Study Design

Total Participants: 150
Study Start date:
November 01, 2014
Estimated Completion Date:
December 31, 2016

Connect with a study center

  • Cincinnati Eye Institute

    Lexington, Kentucky 41017
    United States

    Active - Recruiting

  • Southern Eye Associates

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

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