Epithelial Healing and Visual Outcomes Using Omega-3 Therapy Before and After Photorefractive Keratectomy (PRK) Surgery (Omega-3)
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ClinicalTrials.gov Identifier: NCT01059019 |
Recruitment Status
:
Completed
First Posted
: January 29, 2010
Last Update Posted
: June 21, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Refractive Error | Dietary Supplement: Omega-3 Fatty Acid Supplements | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
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 Start Date : | January 2010 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |

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.
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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:
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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:
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- 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. ]

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Ages Eligible for Study: | 18 Years to 28 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059019
United States, California | |
UCSD Shiley Eye Center | |
La Jolla, California, United States, 92037 |
Principal Investigator: | David J Schanzlin, MD | UCSD Shiley Eye Center |
Publications:
Responsible Party: | David J Schanzlin, DSchanzlin, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT01059019 History of Changes |
Other Study ID Numbers: |
091487 |
First Posted: | January 29, 2010 Key Record Dates |
Last Update Posted: | June 21, 2013 |
Last Verified: | June 2013 |
Keywords provided by David J Schanzlin, University of California, San Diego:
Refractive Surgery PRK Photorefractive Keratectomy Omega 3 Fatty Acids Cornea |
Additional relevant MeSH terms:
Refractive Errors Eye Diseases |