The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity
Phase 2
- Conditions
- Cataract, Dry Eye Disease
- Interventions
- Dietary Supplement: Omega-3 (Triglyceride form)
- Registration Number
- NCT02260973
- Lead Sponsor
- Physician Recommended Nutriceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Safflower Oil Omega-3 (Triglyceride form) vegetable oil Omega-3 Omega-3 (Triglyceride form) re esterified TG omega-3
- Primary Outcome Measures
Name Time Method Visual Acuity 8 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Cincinnati Eye Institute
🇺🇸Lexington, Kentucky, United States
Southern Eye Associates
🇺🇸Greenville, South Carolina, United States