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

Primary Purpose

Refractive Error

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 Fatty Acid Supplements
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Refractive Error focused on measuring Refractive Surgery, PRK, Photorefractive Keratectomy, Omega 3 Fatty Acids, Cornea

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • UCSD Shiley Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Treatment

Arm Description

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.

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

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2010
Last Updated
June 19, 2013
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01059019
Brief Title
Epithelial Healing and Visual Outcomes Using Omega-3 Therapy Before and After Photorefractive Keratectomy (PRK) Surgery
Acronym
Omega-3
Official Title
Epithelial Healing and Visual Outcomes of Patients Using Omega-3 Supplements as an Adjunct Therapy Before and After Photorefractive Keratectomy (PRK) Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
Keywords
Refractive Surgery, PRK, Photorefractive Keratectomy, Omega 3 Fatty Acids, Cornea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Fatty Acid Supplements
Other Intervention Name(s)
TheraTears, Omega 3
Intervention Description
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
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Schanzlin, MD
Organizational Affiliation
UCSD Shiley Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Shiley Eye Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9100105
Citation
Kanellopoulos AJ, Pallikaris IG, Donnenfeld ED, Detorakis S, Koufala K, Perry HD. Comparison of corneal sensation following photorefractive keratectomy and laser in situ keratomileusis. J Cataract Refract Surg. 1997 Jan-Feb;23(1):34-8. doi: 10.1016/s0886-3350(97)80148-4.
Results Reference
background
PubMed Identifier
10670467
Citation
Linna TU, Vesaluoma MH, Perez-Santonja JJ, Petroll WM, Alio JL, Tervo TM. Effect of myopic LASIK on corneal sensitivity and morphology of subbasal nerves. Invest Ophthalmol Vis Sci. 2000 Feb;41(2):393-7.
Results Reference
background
PubMed Identifier
10713225
Citation
Chuck RS, Quiros PA, Perez AC, McDonnell PJ. Corneal sensation after laser in situ keratomileusis. J Cataract Refract Surg. 2000 Mar;26(3):337-9. doi: 10.1016/s0886-3350(99)00416-2.
Results Reference
background
PubMed Identifier
11934197
Citation
Albietz JM, Lenton LM, McLennan SG. Effect of laser in situ keratomileusis for hyperopia on tear film and ocular surface. J Refract Surg. 2002 Mar-Apr;18(2):113-23. doi: 10.3928/1081-597X-20020301-02.
Results Reference
background
PubMed Identifier
11567963
Citation
Poon AC, Geerling G, Dart JK, Fraenkel GE, Daniels JT. Autologous serum eyedrops for dry eyes and epithelial defects: clinical and in vitro toxicity studies. Br J Ophthalmol. 2001 Oct;85(10):1188-97. doi: 10.1136/bjo.85.10.1188.
Results Reference
background
PubMed Identifier
17112189
Citation
Maroon JC, Bost JW, Borden MK, Lorenz KM, Ross NA. Natural antiinflammatory agents for pain relief in athletes. Neurosurg Focus. 2006 Oct 15;21(4):E11. doi: 10.3171/foc.2006.21.4.12.
Results Reference
background
PubMed Identifier
10509643
Citation
Afonso AA, Sobrin L, Monroy DC, Selzer M, Lokeshwar B, Pflugfelder SC. Tear fluid gelatinase B activity correlates with IL-1alpha concentration and fluorescein clearance in ocular rosacea. Invest Ophthalmol Vis Sci. 1999 Oct;40(11):2506-12.
Results Reference
background
PubMed Identifier
9797670
Citation
Prabhasawat P, Tseng SC. Frequent association of delayed tear clearance in ocular irritation. Br J Ophthalmol. 1998 Jun;82(6):666-75. doi: 10.1136/bjo.82.6.666.
Results Reference
background
PubMed Identifier
19277245
Citation
Macsai MS. The role of omega-3 dietary supplementation in blepharitis and meibomian gland dysfunction (an AOS thesis). Trans Am Ophthalmol Soc. 2008;106:336-56.
Results Reference
background
PubMed Identifier
11588457
Citation
Kotani N, Hashimoto H, Kushikata T, Yoshida H, Muraoka M, Takahashi S, Matsuki A. Intraoperative prostaglandin E1 improves antimicrobial and inflammatory responses in alveolar immune cells. Crit Care Med. 2001 Oct;29(10):1943-9. doi: 10.1097/00003246-200110000-00016.
Results Reference
background
PubMed Identifier
10508233
Citation
Narumiya S, Sugimoto Y, Ushikubi F. Prostanoid receptors: structures, properties, and functions. Physiol Rev. 1999 Oct;79(4):1193-226. doi: 10.1152/physrev.1999.79.4.1193.
Results Reference
background
PubMed Identifier
233220
Citation
Pholpramool C. Secretory effect of prostaglandins on the rabbit lacrimal gland in vivo. Prostaglandins Med. 1979 Sep;3(3):185-92. doi: 10.1016/0161-4630(79)90102-2.
Results Reference
background
PubMed Identifier
2365569
Citation
Gilbard JP, Rossi SR, Heyda KG, Dartt DA. Stimulation of tear secretion by topical agents that increase cyclic nucleotide levels. Invest Ophthalmol Vis Sci. 1990 Jul;31(7):1381-8.
Results Reference
background
PubMed Identifier
11383767
Citation
Ambrosio R Jr, Wilson SE. Complications of laser in situ keratomileusis: etiology, prevention, and treatment. J Refract Surg. 2001 May-Jun;17(3):350-79. doi: 10.3928/1081-597X-20010501-09.
Results Reference
background
PubMed Identifier
18650669
Citation
Saad HA, Terry MA, Shamie N, Chen ES, Friend DF, Holiman JD, Stoeger C. An easy and inexpensive method for quantitative analysis of endothelial damage by using vital dye staining and Adobe Photoshop software. Cornea. 2008 Aug;27(7):818-24. doi: 10.1097/ICO.0b013e3181705ca2.
Results Reference
background

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

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