Epithelial Healing and Visual Outcomes Using Omega-3 Therapy Before and After Photorefractive Keratectomy (PRK) Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David J Schanzlin, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01059019
First received: January 28, 2010
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to demonstrate that omega-3 supplement can be use as an adjunct therapy for PRK patients. The investigators believe that omega-3 supplement will reduce the size of persistent epithelial defects (PEDS) and eventually hasten the corneal reepithelialization after PRK surgery. If the outcome of this study proves to be effective, then PRK would be a more attractive option to those seeking refractive treatment.


Condition Intervention
Refractive Error
Dietary Supplement: Omega-3 Fatty Acid Supplements

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Epithelial Healing and Visual Outcomes of Patients Using Omega-3 Supplements as an Adjunct Therapy Before and After Photorefractive Keratectomy (PRK) Surgery

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Visual acuity, tear break up time, and corneal uptake will be assessed. Photographs will be taken. Calculation of the area in diameter will be assessed using Adobe Photoshop. Comparisons between each group will be made. [ Time Frame: 2 and 4 days, 1 week, 3 and 6 months. ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: January 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control
Twenty patients labeled as group A (Control Group) will not receive the omega-3 supplement. The Control Group will be treated in the same standard professional way as our normal refractive patients.
Dietary Supplement: Omega-3 Fatty Acid Supplements
Twenty patients labeled as group A (Control Group) will not receive the omega-3 supplement. The Control Group will be treated in the same standard professional way as our normal refractive patients, while another 20 patients labeled as group B (Treatment group) will be given omega- 3 supplements 1 capsule 3 x a day for 2 weeks pre op and 1 month post op plus the regular post op medications. From these supplements, this will be equivalent to 750 mg of omega 3 fatty acids (both EPH and DHA), 1000 mg of Flaxseed oil, and about 183 IU of vitamin E per day. Patients will be asking to follow up postoperatively after 2 days, 4 days, 1 week, 3 months and 6 months
Other Names:
  • TheraTears
  • Omega 3
Experimental: Treatment
20 patients labeled as group B (Treatment group) will be given omega- 3 supplements 1 capsule 3 x a day for 2 weeks pre op and 1 month post op plus the regular post op medications. From these supplements, this will be equivalent to 750 mg of omega 3 fatty acids (both EPH and DHA), 1000 mg of Flaxseed oil, and about 183 IU of vitamin E per day
Dietary Supplement: Omega-3 Fatty Acid Supplements
Twenty patients labeled as group A (Control Group) will not receive the omega-3 supplement. The Control Group will be treated in the same standard professional way as our normal refractive patients, while another 20 patients labeled as group B (Treatment group) will be given omega- 3 supplements 1 capsule 3 x a day for 2 weeks pre op and 1 month post op plus the regular post op medications. From these supplements, this will be equivalent to 750 mg of omega 3 fatty acids (both EPH and DHA), 1000 mg of Flaxseed oil, and about 183 IU of vitamin E per day. Patients will be asking to follow up postoperatively after 2 days, 4 days, 1 week, 3 months and 6 months
Other Names:
  • TheraTears
  • Omega 3

Detailed Description:

Dry eye and persistent epithelial defects (PEDS) following LASIK and PRK are one of the most common conditions encountered by refractive surgeons and their patient's today.¹⁻⁴ They are associated with significant clinical morbidity in patients resulting in minor problems such as discomfort, to extreme debilitation such as visual loss. There is no accepted definition of persistent epithelial defect (PED) that includes a time period of recovery. We favor the definition given in one text "… when the epithelium fails to re-grow over a defect within the expected time course.⁵ The causes of PED are diverse, with several definite etiologies' including dry eyes, limbal stem cell deficiency, diabetes mellitus and neurotrophic problems. A variety of treatment modalities have been described for PED. The elimination of predisposing associated risk remains a key factor in the management process. Therefore, to prevent and manage this common disorder it is important to have an understanding of the pathophysiology of dry eye after LASIK and PRK. This includes and understanding of the relationship and interaction between inflammation, sensory denervation and essential fatty acid pathways. Reports of clinical efficacy of anti-inflammatory therapies for treatment of dry eye disease provide direct proof of the principle that inflammation is involved in the etiology of dry eye disease. Research has shown that the omega-3 polyunsaturated fatty acids are some of the most effective natural anti inflammatory agents available. The active ingredients in omega 3, EPA ( Eicosapentanoic acid ) which is a 20 carbon omega 3-fatty acid with 5 double-bonds , and DHA ( docosahexanoic acid )which is 22 carbon omega-3 fatty acid with 6 double bond, both found in certain fish oils enhance the conversion of COX ( cyclooxygenase) to prostaglandin E3. A natural anti inflammatory agent, prostaglandin E3 competitively inhibits the effects of the arachidonic acid conversion to prostaglandin E2, a highly inflammatory substance. Prostaglandin E3 also inhibits the synthesis of TNFα and IL-1β, both of which are inflammatory leukotrienes, also by competitive inhibition.⁶ʹ⁷ By decreasing inflammation and stimulating aqueous tear production in rabbits cAMP has been shown to stimulate aqueous tear secretion in dry eye. Furthermore, by decreasing inflammation and augmenting oil and water layers of the tear film, omega-3 supplementation with fish oil rich in EPA may improve both the lipid and aqueous component of the tear film. This may improve surgical outcomes by stabilizing the tear film, reducing epithelial defects and promoting wound healing

  Eligibility

Ages Eligible for Study:   18 Years to 28 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female candidate for PRK with refractive error of -1.00 to -6.00
  • Male or female 18- 28 (may consider increasing this range) years old and >60 years old post cataract surgery for enhancement.
  • Patients without history of diabetes.
  • Patients without history of hemorrhagic stroke.
  • Patient without history of blood dyscrasia.
  • Patient without history of diarrhea, abdominal bloating, and indigestion.
  • Patient without history of peptic ulcer disease, gastroesophageal reflux and gastroesophageal reflux disease.

Exclusion Criteria:

  • Male or female < 18 years old for PRK.
  • Male or female with a refractive error < -1.00 or >-6.00
  • Patient with history of diabetes.
  • Patient with history of hemorrhagic stroke.
  • Patient with history of Blood dyscrasia.
  • Patient with history of peptic ulcer disease, gastroesophageal reflux and gastroesophageal reflux disease.
  • Patient with history of diarrhea, abdominal bloating and indigestion.
  • Pregnant women and women that are lactating (nursing mothers)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059019

Locations
United States, California
UCSD Shiley Eye Center
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: David J Schanzlin, MD UCSD Shiley Eye Center
  More Information

Publications:

Responsible Party: David J Schanzlin, DSchanzlin, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01059019     History of Changes
Other Study ID Numbers: 091487
Study First Received: January 28, 2010
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Refractive Surgery
PRK
Photorefractive Keratectomy
Omega 3 Fatty Acids
Cornea

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 22, 2014