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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02260973
Enrollment
150
Registered
2014-10-09
Start date
2014-11-30
Completion date
2016-12-31
Last updated
2016-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Dry Eye Disease

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.

Interventions

DIETARY_SUPPLEMENTOmega-3 (Triglyceride form)

Sponsors

Physician Recommended Nutriceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Visual Acuity8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026