Ocular Hypertension, Open Angle Glaucoma
Conditions
Brief summary
This study is designed with the intention to further elucidate the effects of omega-3 fatty acids on intraocular pressure (IOP) and signs/symptoms of dry eye. Prior studies have shown statistically significant lowering of IOP with use of omega-3 fatty acids but have only been performed in animal models. This study will be the first to attempt replication in human models. A limited number of studies have shown an increase in tear production/volume as well as a decrease in the subjective symptoms of dry eye, but more studies are needed to better define these effects. Better understanding of the effects of this supplement on intraocular pressure and dry eye will contribute to the expanding knowledge about the pathophysiology of glaucoma/ocular hypertension and dry eye syndrome and potentially lead to further studies about new potential treatment options for these conditions.
Detailed description
The purpose of this research project is to determine the effects of omega-3 fatty acid supplementation on intraocular pressure (IOP) as well as the signs and symptoms of dry eye. We hypothesize that dietary omega-3 fatty acid supplementation will be associated with a significant change in intraocular pressure compared to baseline measurements prior to beginning supplementation. We further hypothesize that omega-3 fatty acid supplementation will be associated with a significant increase in tear production and volume as well as a significant change in patients' subjective complaints of dry eye.
Interventions
None listed
Sponsors
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Ocular Hypertension or Open Angle Glaucoma of mild to moderate severity, with or without previously diagnosed dry eye syndrome, who are currently on monotherapy with a prostaglandin analog. * Age 40-89 of either gender, of any race/ethnicity
Exclusion criteria
* Females who are currently pregnant or planning to become pregnant during the study period * Age \<40 years old * Diagnosis of any other form of glaucoma other than open-angle * Patients with known hypersensitivity (i.e., anaphylactic reaction) to omega-3 fatty acids or any of its components * Patients with cirrhosis or with known liver disease * Patients with diagnosed celiac disease * Patients with a hypersensitivity to fish or shellfish * Patients with paroxysmal or persistent atrial fibrillation * Patients who are currently using medical or recreational marijuana * Patients currently on any anticoagulation therapy including warfarin, dabigatran, apixaban, rivaroxaban, clopidogrel, cilostazol, dipyridamole, prasugrel, ticlopidine, ticagrelor * Patients currently on Lovaza, an omega- 3 fatty acid supplement requiring a prescription * Patients with any recent ocular surgery or laser treatment within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of Omega-3 Fatty Acid Supplementation on Intraocular Pressure | Change in intraocular pressure from baseline over 3 month | Intraocular pressure is measured at the study start, and after three month on supplementation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of Omega-3 Fatty Acid Supplementation on Ocular Surface | Change in Ocular Surface from baseline over 3 month | Tear breakup time, corneal fluorescein staining, and tear osmolarity of Ocular Surface is measured at the study start, and after three month on supplementation |
Countries
United States
Outcome results
None listed