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B. Soloway, M. Swanson, R. Rashid, J. Bai, C. Starr, D. Jardim; Safety and Efficacy of the Moria Epi–K for Epi–LASIK in Four Centers Worldwide . Invest. Ophthalmol. Vis. Sci. 2005;46(13):4340.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose:To assess the safety and efficacy of the Moria Epi–K for Epi–LASIK in the hands of 4 refractive surgeons in the United States, Mexico and China. Methods: Four surgeons performed Epi–LASIK with the Epi–K on 93 eyes. One Single Use head and one Single Use Plus ring were used per patient. Preoperatively, the spherical equivalent range was –9.75 D to +3.75. Keratometry ranged from 40.1 to 49.75 D. Pachymetry ranged from 468 to 634 microns. Flap thickness was measured with ultrasound by subtraction pachymetry. Flap dimensions were measured with manual or laser calipers. Epithelial flap quality was evaluated subjectively. Additionally, flap complications, postoperative BSCVA, patient reported pain level, ability to return to work and time of contact lens removal were reported. All centers were subject to IRB monitoring and adherence to the Helsinki agreement Results: An epithelial flap was successfully created in all eyes. We (BS) achieved an average thickness of 52 +/– 9.6 (38–79) microns in 16 eyes. MS, JB, and RR respectively obtained an average flap thickness of 46 +/– 8.3 (26–65) microns in 32 eyes, 54 +/– 10 (33–73) microns in 27 eyes and 50 +/– 11 (33–71) microns in 18 eyes. The average flap diameter was 9.2 +/– 0.2 (9–9.5) mm. MS, JB, and RR respectively obtained an average flap diameter of 9.2, 9.5 and 9.0 mm. Intra–operative complications were limited to an isolated area of retained epithelium on flap generation in 1 eye and 3 epithelial defects created during flap repositioning with a metal cannula. Postoperatively, 2 eyes had spontaneous loss of their bandage contact lens (BCL). The BCL was removed between day 3 and day 5 postoperatively. A minimum of 51% of patients were able to return to work on post–op day three and 87% by post–op day 4 at any center. No patient reported significant pain by the third post–op day. No eyes lost BSCVA in any center and up to 42% gained one or more lines at the six–month visit. Conclusions: The Epi–LASIK with the Moria Epi–K is a safe procedure. The Epi–K creates predictable and uniform epithelial flaps. Flap management techniques and bandage contact lens selection should be adapted to Epi–LASIK.
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