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

Anat Galor,Constantine D Sarantopoulos,Stephen E Valido,Sneh Patel,Roy C Levitt,Leslie R Small,Michael J Venincasa,Elizabeth R Felix,William Feuer,Adriana Rodriguez

doi:10.3390/jcm8091355

Abstract

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.

Highlights

Laser in-situ keratomileusis (LASIK) is a commonly performed surgical procedure used to correct the refractive error, and while visual outcomes after surgery tend to be excellent, a potential side effect of the procedure is the onset of persistent dry eye (DE) symptoms
Post-LASIK DE symptoms were initially attributed to ocular surface dryness; recent evidence suggests that these symptoms may result from corneal nerve damage induced by LASIK; a recent review highlighted that corneal nerve density might not return to baseline levels, even years after surgery [9]
We found that perioperative pregabalin did not reduce the presence of DE symptoms six months after LASIK

Summary

Introduction

Laser in-situ keratomileusis (LASIK) is a commonly performed surgical procedure used to correct the refractive error, and while visual outcomes after surgery tend to be excellent, a potential side effect of the procedure is the onset of persistent dry eye (DE) symptoms. The Patient Reported Outcomes with LASIK (PROWL) study reported that up to 27% of individuals reported mild or greater DE symptoms six months after LASIK (58 of 216), with new DE symptoms reported in 20% of patients (23/118) [1]. Such figures, within the published range of 20–55% occurrence, have been reported in several retrospective studies [2,3,4,5,6,7,8]. Some patients experience such severe pain that they must pursue invasive procedures, including trigeminal nerve stimulation or intrathecal drug delivery, to obtain relief from pain [12]

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