Purpose: To investigate the safety and efficacy of intraoperative interface steroids for the prophylaxis of diffuse lamellar keratitis (DLK).
Methods: Two centers analyzed 1210 consecutive procedures in a prospective interventional trial. Center A irrigated the lasered stromal bed with balanced salt solution (BSS), instilled a drop of preserved dexamethasone 0.1% suspension on the stromal bed, and replaced the corneal flap. Center B replaced the flap, inserted a multiple port cannula to irrigate the stromal interface with BSS, then introduced 0.5 mL preservative-free prednisolone sodium phosphate 0.5% solution into the stromal interface with another multiple port cannula. All LASIK procedures after a fixed date received intraoperative interface steroids. Consecutive procedures immediately before this date were used as controls.
Results: Center A performed 405 intraoperative interface steroids procedures and contributed 405 controls. Center B performed 200 intraoperative interface steroids procedures and contributed 200 controls. Preoperative refraction and postoperative visual acuity were similar in control and intraoperative interface steroids groups. In center A, 5.7% (30% were stage II) and 2% (all only stage I) of controls and intraoperative interface steroid eyes, respectively, developed DLK; intraoperative interface steroids decreased the rate of DLK by 3.0 times (95% confidence interval: 1.3 to 6.8). In center B, 6.5% of controls developed DLK (15% were stage II); with intraoperative interface steroids, only 1 procedure (0.5%) developed DLK. In both centers, no bilateral DLK or DLK beyond stage I were noted when intraoperative interface steroids were used.
Conclusions: Intraoperative interface steroids safely reduced the incidence and severity of DLK. [J Refract Surg. 2009;25:306-311.]