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Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis?

Sponsored by University of Miami

Phase Quota
Phase 2

Dry eye symptoms can occur after LASIK surgery. They generally get better with time but in some patients, they can persist. The investigators believe that in some individuals, dry eye symptoms after LASIK persist because the nerves in the cornea become hypersensitive. The investigators wish to study if a medication, called pregabalin, can protect corneal nerves at the time of LASIK surgery and decrease the frequency and severity of dry eye symptoms 6 months after surgery. This medication has been used in a similar way to reduce the frequency of uncomfortable sensations after other surgeries (knee, abdomen) but has never been studied in LASIK surgery.

Study Start Date: May 2016

Estimated Completion Date: May 2017

Specialties: Medical Student: Ophthalmology Ophthalmology: Cornea/Anterior Segment,Refractive/Eye Surgery Physician Assistant: Ophthalmology

Interventions

  • Drug: Placebo
  • Drug: Pregabalin

Inclusion criteria

  • 21 and 65 years of age
  • undergoing LASIK (unilateral or bilateral procedure)
  • Females of child-bearing age will need a negative urine or serum pregnancy test at the screening visit
  • ocular and systemic medication regimen has been stable for 3 months

Exclusion criteria

  • Pregnant or lactating, participating in another study with an investigational drug within one month prior to screening
  • Using gabapentin, pregabalin, anti-convulsants, duloxetine, venlafaxine (SNRI), or ri-cyclic antidepressants
  • have a history of allergic, anaphylactic reaction, or severe systemic response to pregabalin or gabapentin
  • use corticosteroids chronically or during the month prior to surgery, or have a history of corneal disease (HSV or varicella zoster keratitis, prior corneal incisions (cataract surgery, radial keratotomy, LASIK), prior corneal ulcer)
  • patients with systemic co-morbidities that may confound DE such as HIV, sarcoidosis, graft-versus host disease or a collagen vascular disease
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners

Study Locations And Contact Information

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