Status:
UNKNOWN
The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity
Lead Sponsor:
Physician Recommended Nutriceuticals
Conditions:
Cataract, Dry Eye Disease
Eligibility:
All Genders
30-90 years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02260973
Start Date
November 1 2014
End Date
December 1 2016
Last Update
August 4 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Cincinnati Eye Institute
Lexington, Kentucky, United States, 41017
2
Southern Eye Associates
Greenville, South Carolina, United States, 29605