The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy

Codet Vision Institute

Status and phase: Completed; Phase 4

Conditions: Pain After Photorefractive Keratectomy

Treatments: Drug: Sugar pill; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT01177514

GABA1

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. History of topical ocular medications within 4 weeks prior to enrollment
2. History of conjunctivitis or ocular inflammation within 4 weeks prior to enrollment
3. History of a previous refractive surgery
4. History of previous diagnosis of corneal disease, degeneration, or glaucoma
5. History of autoimmune disease
6. History of oral anti-histamines currently or within 1 week of study enrollment
7. History of systemic anti-inflammatory or pain medication currently or within 4 weeks of study enrollment
8. Use of oral diuretics or betablocker currently or within 1 week of study enrollment
9. Current diagnosis of dry eye
10. Patients whose Best corrected vision is less than 20/20
11. Patients whose target post operative refraction is not plano
12. Pregnant and lactating

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups, including a placebo group

GABAPENTIN

Experimental group

Description:

Group of patients treated with oral gabapentin

Treatment:

Drug: Gabapentin

PLACEBO

Placebo Comparator group

Description:

Group given the placebo capsules

Treatment:

Drug: Sugar pill