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

August 2, 2016 updated by: Physician Recommended Nutriceuticals

The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity Outcomes In Cases Undergoing Cataract Surgery: A Pilot Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 41017
        • Recruiting
        • Cincinnati Eye Institute
        • Contact:
          • Rachel Crabtree
          • Phone Number: 4120 859-331-9000
    • South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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, both pre and post surgery. (Antibiotic, NSAID and Steroid eye drops)

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, diabetic retinopathy, 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 affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Screening or at any time during the study
  • Participation in any other study involving an investigational drug or device within the past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omega-3
re esterified TG omega-3
Dietary supplement: Omega-3 (Triglyceride form)
Placebo Comparator: Safflower Oil
vegetable oil
Dietary supplement: Omega-3 (Triglyceride form)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Physician Recommended Nutriceuticals

Investigators

  • Principal Investigator: Bradley Williams, MD, Southern Eye Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 6, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 9, 2014

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRN 20145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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