Cataract, Dry Eye Disease Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | December 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 90 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Southern Eye Associates | Greenville | South Carolina |
| United States | Cincinnati Eye Institute | Lexington | Kentucky |
| Lead Sponsor | Collaborator |
|---|---|
| Physician Recommended Nutriceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual Acuity | 8 weeks | No |