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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of a Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers

NCT05990712

Dry Eye Dry Eye Syndromes Cataract

UNKNOWN PHASE4

Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

NCT01367249

Pain Inflammation Cataract

COMPLETED PHASE3

Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

NCT00853970

Pain Inflammation

COMPLETED PHASE3

Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects

NCT00204893

Healthy

COMPLETED PHASE1

Intraocular Steroid After Cataract Surgery Study

NCT00478764

Cataract

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract, Dry Eye Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Omega-3

re esterified TG omega-3

Group Type ACTIVE_COMPARATOR

Omega-3 (Triglyceride form)

Intervention Type DIETARY_SUPPLEMENT

Safflower Oil

vegetable oil

Group Type PLACEBO_COMPARATOR

Omega-3 (Triglyceride form)

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omega-3 (Triglyceride form)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No