Study Supports HydroEye® as Useful Pre-LASIK Strategy

Introduction

Transitory dry eye is a common complication after PRK and LASIK, lasting longer in patients with pre-operative dry eye (1). The anti-inflammatory properties of the fatty acid gamma linolenic acid (GLA) have long been known, and recent studies report that supplemental GLA increases tear concentrations of anti-inflammatory prostaglandin E1 (2,3), and increases tear production while reducing dry eye symptoms in post-PRK patients (4).

Consistent with these findings, are the results from several preliminary investigations of HydroEye®*, reported by Frank A. Bucci Jr, MD at the 2002 and 2003 ASCRS meetings. In the first study, administration of HydroEye daily to 13 normal patients was found to increase mean tear lactoferrin levels by 60% at the end of 8 weeks. Additionally, 12 pre-LASIK patients given HydroEye daily 1-4 weeks prior to LASIK, experienced a 40% increase in lactoferrin when measured the day before the procedure.

Follow-Up Trial

In a follow-up study reported at ASCRS earlier this year (5), Dr. Bucci evaluated the effects of pre-treatment with HydroEye in 40 patients undergoing bilateral LASIK. Twenty patients with a history of evaporative or aqueous-deficient dry eye were assigned to take the daily recommended dose of HydroEye for one month before surgery, continuing for a month post-operatively.The remaining 20 patients, age-matched but with no prior history of dry eye, served as untreated controls.

Tear lactoferrin levels were measured (Tear Profile Analyzer) at baseline, on the day of the procedure, and at one day and one month after surgery. At the beginning of the study, the treated group had a higher incidence of ocular surface disease and a lower lactoferrin level than the control group (.95 vs. 1.1 ng/ml, respectively).

In the treated patients, mean lactoferrin increased a significant 32% during the pre-treatment period, becoming significantly higher (mean 24%) than the control group by the day of surgery. Lactoferrin levels dropped one day post-op in both groups. However the post-surgery decrease was less marked in the treated compared to untreated patients (.88 v .77 ng/ml respectively), with lactoferrin levels still 12% higher in those taking HydroEye. Lactoferrin rose in both groups during the month following surgery, with levels remaining slightly above baseline measurements in the treated group. No difference in lactoferrin was noted between the two groups at the end of this period.

Levels of tear lactoferrin, an indicator of ocular surface health, have been shown to be decreased in those with tear-deficient dry eye, according to the study's author. "Against that background, the results of this study support the pre-operative, prophylactic use of oral omega fatty acids in patients with mild to moderate risk for dry eye after LASIK," Dr. Bucci concluded.

*HydroEye is a patented formulation containing GLA, omega-3 fatty acids, antioxidant vitamin C, and other nutrients needed to convert fatty acids to anti-inflammatory prostaglandins.

References

  1. Toda I ,et al. Laser-assisted in situ keratomileusis for patients with dry eye. Arch Opthalmol 120:1024-28, 2002.
  2. Aragona P, et al. Tear PGE1 levels in dry eye patients after treatment with essential fatty acids. Invvest Ophthalmol Vis Sci 42:5259, 2001.
  3. Barabino S, et al. Systemic linoleic and gamma-linolenic acid therapy in dry-eye syndrome with inflammatory component. Cornea 22(2): 97–101, 2003.
  4. Macri A, et al. Effect of linoleic acid and gamma-linolenic acid on tear production, tear clearance and on the ocular surface after photorefractive keratectomy. Graefes Arch Clin Exp Ophthalmol (published first online, 05/27/2003) Full paper available upon request.
  5. Guttman, C. Omega fatty acid supplements useful strategy before LASIK. Ophthamology Times, Nov 1, 2003.