Journal of Cataract & Refractive Surgery
Volume 30, Issue 1 , Pages 123-126, January 2004

Intraindividual comparison of epithelial defects during laser in situ keratomileusis using standard and zero-compression Hansatome microkeratome heads☆☆

Department of Ophthalmology, Johann Wolfgang Goethe-University, Frankfurt am Main, Germany

Accepted 13 May 2003.

Abstract 

Purpose: To determine the difference between the standard and a modified (zero-compression) Hansatome® microkeratome head (Bausch & Lomb) in the incidence of epithelial defects.

Setting: Department of Ophthalmology, Johann Wolfgang Goethe-University, Frankfurt am Main, Germany.

Methods: Ninety-three patients (186 eyes) with a mean age of 39.1 years ± 9.5 (SD) having laser in situ keratomileusis (LASIK) in both eyes were enrolled in a prospective randomized study using intraindividual comparison. In 1 eye, the flaps were created with the Hansatome microkeratome using the standard Hansatome head and in the other eye, the flaps were created with a microkeratome head with a modified design (zero-compression head). Intraoperative evaluation of epithelial defects was done using a standardized protocol. Statistical evaluation was performed with McNemar and Bowker tests.

Results: Epithelial defects occurred in 21 eyes (22.6%) in which the standard head was used and in 2 eyes (2.1%) in which the zero-compression head was used. In the former group, 15 (16.1%) of the epithelial defects were larger than 1.5 mm2; the remaining 6 (6.4%) were smaller than 1.5 mm2. In the latter group, both epithelial defects were smaller than 1.5 mm2; both patients also had an epithelial defect in the eye in which the standard Hansatome head was used. The difference between the 2 Hansatome heads in the incidence (P<.001, McNemar) and size (P<.001, Bowker) of the epithelial defects was statistically significant.

Conclusions: The Hansatome microkeratome with a zero-compression head significantly reduced the occurrence of intraoperative epithelial defects. The change in the construction of the Hansatome head is a useful improvement in LASIK technology.

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 Supported by a research grant from Bausch & Lomb, Munich, Germany.

☆☆ Dr. Kohnen is a consultant to Bausch & Lomb. None of the other authors has a proprietary or financial interest in any device mentioned.

 Hanns Ackermann, PhD, Institute for Statistics, Johann Wolfgang Goethe-University, assisted in the statistical evaluation of the study and Gerd W.K. Steinkamp, MD, performed some of the LASIK procedures.

PII: S0886-3350(03)00657-6

doi:10.1016/S0886-3350(03)00657-6

Journal of Cataract & Refractive Surgery
Volume 30, Issue 1 , Pages 123-126, January 2004