Trial | NCT01177514  Report issue

Title

The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy
The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy A Prospective, Randomized, Double Blinded, Placebo Controlled Study

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    gabapentin ...

  • Study Participants

    40
The primary aims of this study are to determine if treatment with Gabapentin taken systemically (oral tablets) in patients who have photorefractive keratectomy (PRK) surgical treatments reduces post surgical neuropathic pain and discomfort. The investigators main Hypothesis is that gabapentin given prior to and after refractive surgery prevents central sensitization and local allodynia.
Study Started
Apr 30
2010
Primary Completion
Sep 30
2010
Study Completion
Nov 30
2010
Last Update
Jul 29
2015
Estimate

Drug Gabapentin

Gabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days.

Drug Sugar pill

Sugar pill. One capsule given the night before surgery, q12hrs on the day of surgery and q8hrs for the first 3 postoperative days.

GABAPENTIN Experimental

Group of patients treated with oral gabapentin

PLACEBO Placebo Comparator

Group given the placebo capsules

Criteria 

Inclusion Criteria:

Subjects must be at least 18 years of age
Subjects must not have any corneal disease or degeneration
Subjects must be candidates for LASIK or PRK refractive surgery

Exclusion Criteria:

History of topical ocular medications within 4 weeks prior to enrollment
History of conjunctivitis or ocular inflammation within 4 weeks prior to enrollment
History of a previous refractive surgery
History of previous diagnosis of corneal disease, degeneration, or glaucoma
History of autoimmune disease
History of oral anti-histamines currently or within 1 week of study enrollment
History of systemic anti-inflammatory or pain medication currently or within 4 weeks of study enrollment
Use of oral diuretics or betablocker currently or within 1 week of study enrollment
Current diagnosis of dry eye
Patients whose Best corrected vision is less than 20/20
Patients whose target post operative refraction is not plano
Pregnant and lactating
No Results Posted