The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity
1 other identifier
interventional
150
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2014
CompletedFirst Posted
Study publicly available on registry
October 9, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 4, 2016
August 1, 2016
1.9 years
October 6, 2014
August 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Acuity
8 weeks
Study Arms (2)
Omega-3
ACTIVE COMPARATORre esterified TG omega-3
Safflower Oil
PLACEBO COMPARATORvegetable oil
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cincinnati Eye Institute
Lexington, Kentucky, 41017, United States
Southern Eye Associates
Greenville, South Carolina, 29605, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley Williams, MD
Southern Eye Associates
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2014
First Posted
October 9, 2014
Study Start
November 1, 2014
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
August 4, 2016
Record last verified: 2016-08