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

NCT ID: NCT01059019

Last Updated: 2013-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-05-31

Brief Summary

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.

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

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Omega-3 Fatty Acid Supplements

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: EXPERIMENTAL

Omega-3 Fatty Acid Supplements

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

TheraTears; Omega 3

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

David J Schanzlin

DSchanzlin

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David J Schanzlin, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD Shiley Eye Center

Locations

UCSD Shiley Eye Center

La Jolla, California, United States

Countries

United States

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Other Identifiers

091487

Identifier Type: -

Identifier Source: org_study_id