Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis?
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 1/9/2019 |
Start Date: | July 26, 2016 |
End Date: | December 1, 2018 |
Can Lyrica (Pregabalin) help prevent severe Dry Eye post LASIK surgery?
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.
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.
Inclusion Criteria:
- 18 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
tri-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
We found this trial at
1
site
900 Northwest 17th Street
Miami, Florida 33133
Miami, Florida 33133
Principal Investigator: Anat Galor, MD, MSPH
Phone: 305-450-6050
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