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

June 19, 2013 updated by: David J Schanzlin, University of California, San Diego

Epithelial Healing and Visual Outcomes of Patients Using Omega-3 Supplements as an Adjunct Therapy Before and After Photorefractive Keratectomy (PRK) Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UCSD Shiley Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Omega 3
  • TheraTears
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:
  • Omega 3
  • TheraTears

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
2 and 4 days, 1 week, 3 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: David J Schanzlin, MD, UCSD Shiley Eye Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 091487

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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