Bioptics With LASIK Flap First for the Treatment of High Ametropia Merab L. Dvali, MD, PhD; Nana A. Tsinsadze, MD, PhD; Bella V. Sirbiladze, MD, PhD ioptics, fi rst described by Zaldivar et al,1 is the treat- ABSTRACT ment of refractive error using phakic intraocular PURPOSE: To report the safety and predictability of an B lens (IOL) implantation and excimer laser corneal alternate sequence of the bioptics procedure. ablation. Candidates for this procedure included patients with high refractive errors (with astigmatism) that surpass METHODS: In this prospective study of 50 eyes, pha- the treatment range for excimer laser refractive surgery and kic intraocular lenses (IOLs) and pseudophakic IOLs were patients whose corneal thickness will not allow full treat- implanted, followed by LASIK. The corneal fl ap was cre- ment of refractive error. ated, followed by lens implantation 3 days later. Laser ablation was performed to the stromal bed 3 months Over time, the defi nition of bioptics has expanded to in- later. Fifty eyes with varying degrees of refractive clude phakic, pseudophakic, and clear lens extraction cases error (range of manifest refraction spherical equivalent followed by surgery on the corneal plane. Phakic or pseudo- [MRSE], Ϫ19.50 to ϩ8.50 diopters [D]) were treated. phakic surgery followed by refractive surgery is the most com- Follow-up ranged from 3 months to 4 years postopera- mon form of bioptics.2 In this procedure, the lens is implanted tively. to correct the majority of refractive error followed by LASIK RESULTS: No intra- or postoperative complications performed at least 3 months postoperatively to correct the re- occurred. Postoperatively, MRSE ranged from Ϫ0.75 to maining refractive error. The advantages of this procedure in- ϩ0.50 D. Mean residual refractive astigmatism ranged clude its ability to correct refractive errors of Ϫ20.00 diopters from ϩ0.25 to ϩ1.50 D postoperatively. Postoperative (D) or higher1 and to refi ne residual refractive error that may uncorrected visual acuity was 20/20 or better in 82% have been induced by the primary implantation surgery. (41/50) of eyes and 20/40 or better in 98% (49/50) of eyes. No eyes experienced a loss of best spectacle-cor- A small number of studies report bioptics to be safe and pre- 1-3 rected visual acuity postoperatively. dictable. However, concerns about vitreoretinal complications or endothelial touch due to the transient increase in intraocular CONCLUSIONS: This modifi cation of the sequence of pressure during the secondary LASIK procedure4 may warrant procedures for bioptics provided safe and predictable an alternative sequence of events for this procedure. outcomes. [J Refract Surg. 2009;25:S160-S162.] In this study, we present the safety and predictability of bioptics in 50 eyes that underwent the procedure using a dif- ferent sequence of steps than those traditionally followed. In the sequence reported, the corneal fl ap was created 2 to 3 days before the phakic, pseudophakic, or clear lens extrac- tion surgery, followed by laser ablation 3 months later. From Tbilisi State Medical University, Tbilisi, Georgia. The authors have no financial interest in the materials presented herein. Presented in part at the NIDEK NAVEX Seminar, XI Congress of the Middle East African Council of Ophthalmology; March 29 - April 1, 2007; Dubai, UAE. Correspondence: Merab L. Dvali, MD, PhD, 29 Vazha-Pshavela Ave, Tbilisi, Georgia. Tel: 99 532 393423; Fax: 99 532 001153; E-mail: [email protected] S160 Commercially Sponsored Section journalofrefractivesurgery.com Bioptics for High Ametropia/Dvali et al PATIENTS AND METHODS lens, 4 eyes were implanted with the ICL lens, and 12 A prospective study of 50 eyes of 27 patients who un- eyes were implanted with the Acrysof pseudophakic derwent the bioptics procedure was conducted. Of the lens. eyes studied, 44 were myopic and 6 were hyperopic. Postoperatively, MRSE ranged from Ϫ0.75 to ϩ0.50 D. Nine eyes represented cases of traumatic or congenital Mean residual refractive astigmatism ranged from cataract, 3 eyes underwent clear lens extraction, and ϩ0.25 to ϩ1.50 D at follow-up. Postoperative UCVA 38 eyes underwent phakic IOL implantation for prima- was 20/20 or better in 82% (41/50) of eyes and 20/40 ry myopia or hyperopia. All surgeries were performed or better in 98% (49/50) of eyes. No eyes experienced a by an experienced surgeon (M.L.D.). Mean patient age loss of BSCVA postoperatively. No intra- or postopera- was 27 years (range: 18 to 56 years). Twenty-three tive complications occurred. patients underwent bilateral surgery. The preopera- tive manifest refraction spherical equivalent (MRSE) DISCUSSION ranged from Ϫ19.50 to ϩ8.50 D, with astigmatism This investigation of the bioptics procedure found ranging from 2.00 to 5.50 D. that it was safe and predictable across a variety of Pre-, peri- (between intraocular and corneal surgery), refractive cases. In our study, we implanted phakic and postoperatively, all patients underwent an ophthal- and pseudophakic IOLs, yet the results were similar mic examination that included measurement of dis- to those reported for LASIK for high refractive errors.5 tance uncorrected visual acuity (UCVA) and best spec- Using a similar sample size and treatment range for tacle-corrected visual acuity (BSCVA), pupillometry, LASIK, He et al5 reported no loss of BSCVA, as was manifest refraction, cycloplegic refraction, slit-lamp also reported in our study. examination, tonometry, corneal topography using the In the present study, postoperative UCVA was simi- NIDEK OPD-Scan (NIDEK Co Ltd, Gamagori, Japan), lar to or better than that reported using the standard manual keratometry, endothelial cell count, corneal bioptics procedure of intraocular surgery followed by pachymetry, gonioscopy, ultrasonography, and dilated corneal surgery. For example, in the original bioptics funduscopy. Postoperative examinations were con- article, Zaldivar et al1 reported UCVA of 20/20 or better ducted at 1 week, monthly for 3 months, 6 months, 12 in 3% of eyes, which is signifi cantly lower than our re- months, and yearly for 3 years. sults of 81.2%. However, Zaldivar et al treated Ϫ18.75 The phakic lenses used were: Phakic 6H anterior to Ϫ35.00 D, and it is unclear whether some of the chamber IOL (Ophthalmic Innovations Internation- patients with extremely high myopia in the Zaldivar al, Ontario, Canada); PRL (IOL Tech, La Rochelle, study were amblyopic, accounting for the low UCVA. France); ICL (STAAR Surgical Co, Monrovia, Calif); Furthermore, unlike that in the study by Zaldivar et and Acrysof pseudophakic lens (Alcon Laboratories al,1 our study sample included patients with both low Inc, Ft Worth, Tex). and high refractive error instead of just patients with A nasal hinged corneal fl ap was fi rst created using extreme myopia. the NIDEK MK-2000 keratome (NIDEK Co Ltd) without Safety in our study was similar to that reported by fl ap lift but by washing the interface thoroughly with Velarde et al3 using phakic IOLs with LASIK on a simi- balanced salt solution using an irrigating cannula. Pha- lar refractive range but a smaller sample size. Velarde et kic or pseudophakic lens implantation or clear lens al also reported no clinically signifi cant loss of BSCVA extraction was performed 2 to 3 days later. Once the postoperatively.3A follow-up study by Zaldivar et al,2 refraction stabilized after the intraocular procedure, who performed bioptics for low to extreme myopia the fl ap was relifted using a Sinsky hook to break the with a similar refractive range, also reported no loss adhesions at the fl ap edge and forceps were used to of BSCVA. lift the fl ap and refl ect it nasally. Laser ablation was Bioptics has some advantages over phakic and pseu- delivered to the corneal stroma using the Plano Scan dophakic IOLs and LASIK alone for the treatment of Technolas 217 C-LASIK scanning-spot excimer laser high refractive errors. First, based on our results and (Bausch & Lomb Inc, Rochester, NY) using software those in the peer-reviewed literature,2,3 low to extreme version V2.9993R1.51. levels of refractive error can be treated predictably on par with LASIK. Second, the bioptics approach allows RESULTS for a larger functional optical zone. The reduction in Follow-up ranged from 3 months to 4 years post- functional optical zone for phakic IOLs and LASIK is operatively. Thirty-one eyes with high myopia and well documented.6-8 By using a combination of lens astigmatism were implanted with the Phakic 6H ante- implantation and LASIK to correct the refractive error, rior chamber IOL, 3 eyes were implanted with the PRL there is a relatively lower reduction in the functional Journal of Refractive Surgery Volume 25 January (Suppl) 2009 Commercially Sponsored Section S161 Bioptics for High Ametropia/Dvali et al optical zone postoperatively. Third, as Zaldivar et al2 cedure, followed by laser ablation after the refraction report, the predictability of the results will improve be- stabilized, was safe and predictable for the treatment cause LASIK can correct any residual refractive error. of low to high myopic and hyperopic refraction errors Finally, bioptics is a solution for patients with refrac- with astigmatism. tive errors beyond the scope of lens implantation and LASIK and in borderline cases (eg, inadequate stromal REFERENCES residual bed thickness). 1. Zaldivar R, Davidorf JM, Oscherow S, Ricur G, Piezzi V. Com- bined posterior chamber phakic intraocular lens and laser in In this study, we created the LASIK fl ap prior to lens situ keratomileusis: bioptics for extreme myopia. J Refract Surg. insertion, which is substantially different from the 1999;15:299-308. technique recommended for the bioptics procedure. 2. Zaldivar R, Oscherow S, Piezzi V. Bioptics in phakic and pseu- Zaldivar’s original bioptics procedure is a two-step dophakic intraocular lens with the Nidek EC-5000 excimer la- procedure in which intraocular surgery is performed ser.