NCT01059019

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

January 28, 2010

Last Update Submit

June 19, 2013

Conditions

Refractive Error

Keywords

Refractive SurgeryPRKPhotorefractive KeratectomyOmega 3 Fatty AcidsCornea

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 and 4 days, 1 week, 3 and 6 months.

Study Arms (2)

Control

SHAM COMPARATOR

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

Treatment

EXPERIMENTAL

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

Interventions

Omega-3 Fatty Acid SupplementsDIETARY_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

Also known as: TheraTears, Omega 3
ControlTreatment

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Shiley Eye Center

La Jolla, California, 92037, United States

Location

Related Publications (15)

  • 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.

    PMID: 9100105BACKGROUND

  • 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.

    PMID: 10670467BACKGROUND

  • 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.

    PMID: 10713225BACKGROUND

  • 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.

    PMID: 11934197BACKGROUND

  • 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.

    PMID: 11567963BACKGROUND

  • 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.

    PMID: 17112189BACKGROUND

  • 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.

    PMID: 10509643BACKGROUND

  • 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.

    PMID: 9797670BACKGROUND

  • 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.

    PMID: 19277245BACKGROUND

  • 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.

    PMID: 11588457BACKGROUND

  • 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.

    PMID: 10508233BACKGROUND

  • 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.

    PMID: 233220BACKGROUND

  • 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.

    PMID: 2365569BACKGROUND

  • 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.

    PMID: 11383767BACKGROUND

  • 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.

    PMID: 18650669BACKGROUND

MeSH Terms

Conditions

Refractive ErrorsCorneal Diseases

Interventions

Carboxymethylcellulose SodiumDocosahexaenoic Acids

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

MethylcelluloseCelluloseGlucansPolysaccharidesCarbohydratesFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • David J Schanzlin, MD

    UCSD Shiley Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DSchanzlin

Study Record Dates

First Submitted

January 28, 2010

First Posted

January 29, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations

US(1)