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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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