Pregabalin Failed to Prevent Dry Eye Symptoms after Laser-Assisted in Situ Keratomileusis (LASIK) in a Randomized Pilot Study

Purpose: Perioperative pregabalin administration has been found to reduce the risk of persistent pain after a variety of surgical procedures. However, this approach has not been tested in relation to eye surgery. As such, the purpose of this study was to evaluate whether perioperative pregabalin can reduce the presence of dry eye (DE) symptoms, including eye pain, six months after laser-assisted in situ keratomileusis (LASIK). Methods: Prospective, masked, randomized single-center pilot study. Patients were treated with either pregabalin (oral solution of pregabalin 150 mg twice daily, first dose prior to surgery, continued for a total of 28 doses over 14 days) or placebo solution. The primary outcome was dry eye symptoms as measured by the Dry Eye Questionnaire 5 (DEQ-5). Secondary outcome measures included pain-related eye symptoms. Results: In total, 43 individuals were enrolled in the study and randomized to pregabalin (n = 21) or placebo (n = 22). Of those, 42 individuals completed the final visit after six months of follow-up. Some differences were noted between the two groups at baseline, including a higher frequency of females in the pregabalin group. At 6-months, there were no significant differences in the percentage of patients with DE symptoms (DEQ5 >= 6, 57% vs. 33%, p = 0.14), DE symptom severity (DEQ5, 6.6 +/- 5.0 vs. 4.5 +/- 4.2, p = 0.14), ocular pain intensity (numerical rating scale, 1.10 +/- 1.48 vs. 0.38 +/- 0.97, p = 0.08), or neuropathic pain complaints (Neuropathic Pain Symptom Inventory-Eye, 2.81 +/- 4.07 vs. 3.14 +/- 5.85, p = 0.83) between the pregabalin and control groups. Ocular signs were likewise similar between the groups, and of note, did not correlate with DE symptoms. The strongest predictor of DE symptoms six months post-surgery was the presence of DE symptoms prior to surgery. Conclusions: Perioperative pregabalin did not reduce the frequency or severity of DE symptoms at a six month follow-up after LASIK in this small pilot study.