Jin Kook Kim, MD, Sung Soo Kim, MD, Hyung Keun Lee, MD, In Sik Lee, MD, Gong Je Seong, MD, Eung Kweon Kim, MD, Sueng Han Han, MD

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1 articles Laser in situ keratomileusis versus laser-assisted subepithelial keratectomy for the correction of high myopia Jin Kook Kim, MD, Sung Soo Kim, MD, Hyung Keun Lee, MD, In Sik Lee, MD, Gong Je Seong, MD, Eung Kweon Kim, MD, Sueng Han Han, MD Purpose: To compare the visual and refractive outcomes of laser in situ keratomileusis (LASIK) and laser-assisted subepithelial keratectomy (LASEK) in the treatment of high myopia. Setting: Institute of Vision Research, Department of Ophthalmology, College of Medicine, Yonsei University, and Balgeunsesang Ophthalmology Clinic, Seoul, South Korea. Methods: Four hundred seventy eyes of 240 patients with manifest refraction spherical components greater than 6.00 diopters (D) were assigned to 2 groups: 324 eyes (167 patients) were treated with LASIK and 146 eyes (73 patients), with LASEK. Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), remaining refractive error, corneal haze, and complications were followed in both groups for 12 months. Results: At 12 months, the mean spherical equivalent (SE) was within 0.50 D of emmetropia in 205 eyes (63.3%) in the LASIK group and 81 eyes (55.5%) in the LASEK group and within 1.00 D in 261 eyes (80.6%) and 104 eyes (71.2%), respectively. The UCVA was 20/25 or better in 269 LASIK eyes (83.0%) and 111 LASEK eyes (76.0%). There was more than a 1-line loss of BSCVA in 4 LASIK eyes (1.2%) and 21 LASEK eyes (14.3%). The between-group differences in SE, magnitude of cylinder, UCVA, and haze were statistically significant (P.05). Conclusions: Both LASIK and LASEK were safe and effectively treated eyes with high myopia. Laser in situ keratomileusis provided superior results in visual predictability and corneal opacity. J Cataract Refract Surg 2004; 30: ASCRS and ESCRS Laser in situ keratomileusis (LASIK) has shown encouraging results in the treatment of high myopia and astigmatism. 1 3 Despite the advantages of the procedure, epithelial ingrowth, corneal flap-related compli- cations, and corneal ectasia have been reported. 4 6 Accepted for publication December 5, Reprint requests to Hyung Keun Lee, MD, Department of Ophthalmol- ogy, Yong-Dong Severance Hospital, Dogok-dong, Kangnam- Gu, Seoul , South Korea. Laser-assisted subepithelial keratectomy (LASEK) is another approach to photorefractive keratectomy (PRK), which creates an epithelial flap that is replaced after photorefractive ablation. It is hypothesized that the epithelial flap decreases changes in stromal keratocytes and reduces the production of extracellular matrix and collagen. 7 This may result in less postoperative haze than with PRK and more favorable visual outcomes. In addition, since no lamellar flap is created, LASEK may retain the biomechanical stability seen with PRK and therefore be an alternative to LASIK, in which corneal thickness may be reduced ASCRS and ESCRS /04/$ see front matter Published by Elsevier Inc. doi: /j.jcrs

2 With moderate degrees of myopia, the visual outkeratome 12 o clock and 5 o clock positions. A Hansatome microcomes (Bausch & Lomb Surgical) was used to create a and incidence of postoperative stromal haze in flap of 160 m. Excess liquid was removed with a Merocel LASEK patients appear to be superior to those in PRK sponge (Medtronic Solan). The flap was raised using a spatula patients Additionally, LASEK has more favorable and the stromal bed exposed. The Nidek EC-5000 excimer results than LASIK. 11 laser was fired on the dried corneal surface with the ablation With surface ablation, the correction of high de- centered over the entrance pupil. The flap was replaced using grees of myopia produces more corneal haze and regres- a spatula and the peripheral epithelial markings. The epithelial sion than the correction of low degrees of myopia. 12,13 and stromal portions of the flap were then irrigated with If the cornea is thick enough, LASIK may be preferred a cannula. to PRK in eyes with high myopia because of reduced Postoperatively, ofloxacin 0.3% (Tarivid ) and diclo- fenac 0.1% were instilled in the treated eye. The lid speculum postoperative discomfort, improved immediate acuity, was removed, and a therapeutic contact lens (Focus, and less corneal haze. 14,15 With the suggested advantages Bausch & Lomb) was placed on the cornea. Patients were of LASEK over PRK, there is a potential for less postop- instructed to apply 1 drop of Tarivid and artifical tears (hyalerative discomfort, faster visual rehabilitation, and re- uronic acid 0.1% [Hyalrein ]) every 2 hours. One day postoperatively, duced haze in highly myopic patients. the therapeutic contact lens was removed and To our knowledge, there has been no comparison Tarivid and flurorometholone 0.1% (Fluorometholone) were of the visual and refractive outcomes of LASIK and administrated 4 times daily for 1 week, 2 times daily for 1 month, and once a day for 1 month. LASEK in the treatment of high myopia by a single surgeon. In this study, we retrospectively compared the Laser-Assisted Subepithelial Keratectomy visual and refractive outcomes, changes in best spectacle- A speculum was applied to the patient s eye, and proparacorrected visual acuity (BSCVA), and associated compli- caine hydrochloride (Alcaine ) was instilled. An alcohol solucations in patients who had LASIK or LASEK for high tion cone (J2905, Janach) with an 8.5 mm diameter was myopia and myopic astigmatism. placed on the eye. Twenty percent of the alcohol solution was instilled inside the cone, left for about 20 seconds, and then carefully washed off with a balanced salt solution so the Patients and Methods epithelium around the flap was not disturbed. The epithelial Two hundred forty patients were enrolled in this study flap was gently lifted with an epithelial microhoe (J2915A, between December 2001 and June 2002 for a sample of 470 Janach) and peeled back as a single sheet toward the 12 consecutive eyes. Laser in situ keratomileusis was performed o clock position using a spatula (J2910A, Janach). Excimer in 324 eyes of 167 patients and LASEK, in 146 eyes of 73 laser treatment was performed in the usual manner using the patients. In all patients, myopia was greater than 6.00 same nomogram and laser system as in LASIK. The flap was diopters (D) (range 6.00 to D) and astigmatism washed with a balanced salt solution and then repositioned was less than 4.50 D. The preoperative ophthalmic examinathen carefully with a spatula. A therapeutic soft contact lens was tion included slitlamp biomicroscopy, intraocular pressure, placed on the eye. fundoscopy, measurement of pupil diameter, Schirmer test, Postoperatively, the eyes were checked daily until the manifest refractions, corneal keratometry, corneal topograinstructed epithelial defect was completely closed. The patients were phy, corneal pachymetry, and visual field examination. No to apply 1 drop of diclofenac and Tarivid every patient had a history of refractive procedures, keratoconus, 2 hours and artificial tears every hour until epithelial healing cataract surgery, diabetes, glaucoma, connective tissue disorcurred, was complete. After complete reepithelialization had oc- ders, or retinal disease. All refractive surgery was performed Tarivid and Fluorometholone were administered 4 by the same surgeon (J.K.K). Both procedures, including the times daily for 1 week and 2 times daily for 1 month. potential advantages, disadvantages, and complications, were Routine postoperative examinations were scheduled at fully described to patients who met the criteria. Each patient 1 week and then monthly up to 1 year. In the LASEK eyes, was then allowed to select the procedure. daily follow-up examinations were scheduled until epithelial healing was complete; subsequent examinations were as Laser In Situ Keratomileusis above. The uncorrected visual acuity (UCVA), manifest refraction, Laser in situ keratomileusis was performed under topical tonometry, and slitlamp biomicroscopy were per- anesthesia with proparacaine hydrochloride 0.5% (Alcaine ). formed at all examinations. Subepithelial corneal haze levels A rigid eyelid speculum was used. Two radial marks were were checked at the slitlamp at 6 and 12 months and graded made with a radial marker dipped in gentian violet at the from 0 to 4 according to the method of Fantes et al J CATARACT REFRACT SURG VOL 30, JULY 2004

3 Table 1. Preoperative independent variables. Variable LASIK (n 324 Eyes) LASEK (n 146 Eyes) P Value Age* Mean SD NS* Range Sex (male/female) 55/112 20/53 NS Spherical equivalent (D) Mean SD NS* Range Degree of cylinder Mean SD NS* Range LASEK laser-assisted subepithelial keratectomy; LASIK laser in situ keratomileusis; NS not significant * Unpaired Student t test Chi-square test Data analysis was performed using the Statistical Analysis D in the LASEK group; P.067). System (version 6.12, SAS Institute Inc.). The probability From the third month, the between-group difference value of P.05 was considered statistically significant. in the mean SE was statistically significant: 0.29 Results 0.89 D in the LASIK group and D in the LASEK group at 3 months; D and The preoperative characteristics of the patients are , respectively, at 6 months; and 0.77 shown in Table 1. At the preoperative examination, the 1.01 D and D, respectively, at 12 months between-group differences in the independent variables (all P.05). Additionally, in the LASEK eyes, there were not statistically significant. was a gradual increase in the mean SE at 6 months. In The mean postoperative spherical equivalent (SE) the LASIK eyes, there was little change in the mean SE changes are shown in Figure 1. From the first month, after 3 months. the remaining SE was higher in the LASEK group than At 12 months, in the LASIK eyes, the mean SE in the LASIK group. At 1 month, the SE appeared refraction was within 1.00 D of emmetropia in 261 slightly hyperopic in both groups but the between- eyes (80.6%) and within 0.50 D in 205 eyes (63.3%). group difference was not statistically significant In the LASEK eyes, it was within 1.00 D of emmetro- ( 0.43 D 0.78 [SD] in the LASIK group and pia in 104 eyes (71.2%) and within 0.50 D in 81 eyes (55.5%) (P.00) (Table 2). In LASIK eyes, the mean postoperative astigmatism remained stable from 1 to 12 months. At 1 month, the magnitude of cylinder was within 1.00 D of the intended correction in 303 LASIK eyes (93.5%) and 135 LASEK eyes (92.5%) (P.05). At 12 months, it was within 1.00 D in 295 LASIK eyes (91.1%) and 109 LASEK eyes (74.7%) (P.00) (Table 3). The between-group difference in UCVA was statistically significant from 1 to 12 months postoperatively (Table 4). At 12 months, the UCVA was 20/20 or better in 232 LASIK eyes (71.6%) and 88 LASEK eyes (60.3%); 20/25 or better in 269 (83.0%) and 111 Figure 1. (Kim) The mean SE after LASIK and LASEK. (76.0%), respectively; and 20/40 or better in 307 J CATARACT REFRACT SURG VOL 30, JULY

4 Table 2. Attempted and achieved SE after LASIK (n 224) and LASEK (n 146). 1* 6* 12* Diopter LASIK LASEK LASIK LASEK LASIK LASEK LASEK laser-assisted subepithelial keratectomy; LASIK laser in situ keratomileusis; SE spherical equivalent * P.05, chi-square test Table 3. Magnitude of postoperative refractive cylinder after LASIK (n 224) and LASEK (n 146). 1 6* 12* Diopter LASIK LASEK LASIK LASEK LASIK LASEK LASEK laser-assisted subepithelial keratectomy; LASIK laser in situ keratomileusis * P.05, chi-square test Table 4. Uncorrected visual acuity after LASIK (n 224) and LASEK (n 146). 1* 6* 12* UCVA LASIK LASEK LASIK LASEK LASIK LASEK 20/ / / / LASEK laser-assisted subepithelial keratectomy; LASIK laser in situ keratomileusis; UCVA uncorrected visual acuity * P.01, chi-square test Figure 2. (Kim) Changes in BSCVA after LASIK (n 224) and LASEK (n 146) at 1 month. Figure 3. (Kim) Changes in BSCVA after LASIK (n 224) and LASEK (n 146) at 6 months J CATARACT REFRACT SURG VOL 30, JULY 2004

5 Figure 4. (Kim) Changes in BSCVA after LASIK (n 224) and LASEK (n 146) at 12 months. LASIK VERSUS LASEK FOR HIGH MYOPIA Corneal flap displacements were found on the first postoperative day in 4 LASIK eyes (1.2%). In all 4, corneal flap folds that required repositioning surgery on the same day were found. Epithelial ingrowth, severe diffuse lamellar keratitis, and flap infection were not found in LASIK eyes. Discussion In our study, LASIK and LASEK corrected high myopic refractive errors successfully up to 1 year postoperatively. However, the LASIK procedure was found to be a more favorable method for correcting high myopia than LASEK. Helmy and coauthors 17 report that residual refractive errors were within 1.00 D of emmetropia after LASIK in 34 (85.0%) of 40 eyes with more than 6.00 D of myopia 12 months after surgery using the Summit OmniMed excimer laser. Zaldivar and coauthors 2 report that 70 (83.3%) of 84 eyes were within 1.00 D of emmetropia 6 months after surgery using the Nidek EC-5000, which was the laser system used in our study. In LASIK eyes, our outcomes were similar to those in previous reports of LASIK for high myopia. However, when comparing our LASEK results with those in PRK reports, the LASEK method showed supe- rior refractive predictability in correcting high myopia. (94.8%) and 133 (91.1%), respectively (P.01). The BSCVA was better in the LASIK eyes than the LASEK eyes (Figures 2 to 4). There was a 1- or 2-line loss of BSCVA in 4 LASIK eyes (1.2%) and 21 LASEK eyes (14.7%) at 12 months. No LASIK eye lost more than 2 lines of BSCVA. Four LASEK eyes (2.7%) had lost 3 lines at 12 months. Sixteen LASIK eyes (4.9%) and 2 LASEK eyes (1.4%) gained 1 or 2 lines of BSCVA (Figure 4). The main reasons for decreased BSCVA in LASEK eyes were stromal opacity with myopic regression (12.3%), irregular astigmatism (1.4%), and eccentric ablation (0.7%); in LASIK eyes, the reasons were flap-related complications, which were the result of ir- Previous studies report that 12 months after PRK, the regular astigmatism, interface haze, and a combination remaining SE was within 1.00 D in 29.0% to 68.0% of both. of eyes. 12,17 19 At 1 month, the corneal haze score was less than There is controversy about comparing visual and refractive outcomes of LASEK and PRK. 10,20,21 However, generally, LASEK eyes have more favorable refractive outcomes than PRK eyes. 13,22 The mechanism ex- grade 1 in all eyes. At 12 months, the score was above 2 in 11 LASEK eyes (7.5%). No LASIK eye had detectable haze (Table 5) (P.01). Table 5. Incidence and grade of corneal haze after LASIK (n 224) and LASEK (n 146). 1* 6* 12* Haze Grade LASIK LASEK LASIK LASEK LASIK LASEK * P.05, chi-square test J CATARACT REFRACT SURG VOL 30, JULY

6 plaining why LASEK produced more favorable refrac- References tive results than PRK is not known. The epithelial flap 1. Trokel SL, Srinivasan R, Braren B. Excimer laser surgery of the cornea. Am J Ophthalmol 1983; 96: remaining after surgery may help stromal wound healing 2. Zaldivar R, Davidorf JM, Oscherow S. Laser in situ after excimer laser surgery. 8,11,20 keratomileusis for myopia from 5.50 to diop- Despite the improved surgical results with LASEK, ters with astigmatism. J Refract Surg 1998; 14:19 25 the visual and refractive outcomes in highly myopic 3. Hersh PS, Brint SF, Maloney RK. Photorefractive keratectomy eyes were not better after LASEK than after LASIK. versus laser in situ keratomileusis for moderate The LASIK eyes had a faster recovery and more stable to high myopia; a randomized prospective study. Ophthalmology 1998; 105: ; discussion by JH Tavisual acuity than the LASEK eyes. Recovery of useful lamo, vision after LASEK took at least 5 days as the corneal 4. Alió JL, Artola A, Claramonte PJ, et al. Complications epithelium healed, and the vision continued to improve of photorefractive keratectomy for myopia: two year folgradually over several months. At 12 months, the be- low-up of 3000 cases. J Cataract Refract Surg 1998; tween-group difference in UCVA was statistically signif- 24: icant. We think the increased corneal haze and refractive 5. Schmitt-Bernard C-FM, Lesage C, Arnaud B. Keratec- tasia induced by laser in situ keratomileusis in keratocoinstability in LASEK eyes resulted in the decreased nus. J Refract Surg 2000; 16: UCVA. 6. Seiler T, Holschbach A, Derse M, et al. Complications Sher et al. 23 report a reduction in BSCVA by 2 of myopic photorefractive keratectomy with the excimer lines in 15% of eyes after PRK. Recently, Shahinian 24 laser. Ophthalmology 1994; 101: reported a 1-line BSCVA loss in 9 of 55 LASEK-treated 7. Shah S, Sebai Sarhan AR, Doyle SJ, et al. The epithelial eyes (16.3%) at 12 months. In our study, 21 LASEK flap for photorefractive keratectomy. Br J Ophthalmol 2001; 85: eyes (14.4%) had a reduction in BSCVA of more than 8. Dastjerdi MH, Soong HK. LASEK (laser subepithelial 1 line at 12 months. Regarding BSCVA, our results keratomileusis). Curr Opin Ophthalmol 2002; 13:261 were similar to those in previous PRK studies. Decreased 263 BSCVA in LASIK eyes is known to be associated with 9. Kornilovsy IM. Clinical results after subepithelial photoflap-related complications, including a shifted flap, refractive keratectomy (LASEK). J Refract Surg 2001; 17:S222 S223 wrinkles, and epithelial ingrowth. 25 A loss of 2 or more 10. Lee JB, Seong GJ, Lee JH, et al. Comparison of laser lines of BSCVA has been reported in between 1.6% epithelial keratomileusis and photorefractive keratecand 4.7% of LASIK patients. 26,27 In our study, however, tomy for low to moderate myopia. J Cataract Refract only 1.2% of eyes had more than a 1-line loss of BSCVA. Surg 2001; 27: We think the decreased incidence of BSCVA loss after 11. Scerrati E. Laser in situ keratomileusis vs laser epithelial LASIK is associated with evolution of the micro- keratomileusis (LASIK vs LASEK). J Refract Surg 2001; 17:S219 S221 keratome and improvement in surgical techniques. 12. Heitzmann J, Binder PS, Kasser BS, Nordan LT. The Considering the improvement in microkeratome qual- correction of high myopia using excimer laser. Arch ity, improvement in LASIK results is to be expected. Ophthalmol 1993; 111: Corneal scars and regression in myopia after excimal 13. Condon PI, Mulhern M, Fulcher T, et al. Laser intrastromer laser keratectomy usually develop 1 to 3 months keratomileusis for high myopia and myopic astigma- tism. Br J Ophthalmol 1997; 81: after surgery and persist for several years. 23 Thus, it is 14. Pallikaris IG, Papatzanaki ME, Siganos DS, Tsilimbaris possible that the corneal haze will diminish and the MK. A corneal flap technique for laser in situ keratomilrefractive results and visual acuity improve in the eyes eusis; human studies. Arch Ophthalmol 1991; 109: in this study, especially the LASEK eyes In conclusion, the results of this study indicate that 15. Farah SG, Azar DT, Gurdal C, Wong J. Laser in situ LASIK and LASEK are effective for the correction of keratomileusis: literature review of a developing technique. J Cataract Refract Surg 1998; 24: high myopia. However, UCVA, BSCVA, predictability 16. Fantes FE, Hanna KD, Waring GO III, et al. Wound of refractive errors, and decreased corneal opacity were healing after excimer laser keratomileusis (photorefracbetter after LASIK than after LASIK up to 1 year postop- tive keratectomy) in monkeys. Arch Ophthalmol 1990; eratively. A long-term follow-up is needed. 108: J CATARACT REFRACT SURG VOL 30, JULY 2004

7 17. Helmy SA, Salah A, Badawy TT, Sidky AN. Photorefrac- 24. Shahinian L Jr. Laser-assisted subepithelial keratectomy tive keratectomy and laser in situ keratomileusis for myo- for low to high myopia and astigmatism. J Cataract pia between 6.00 and diopters. J Refract Surg Refract Surg 2002; 28: ; 12: Iskander NG, Peters NT, Anderson Penno E, Gimbel 18. Chan WK, Heng WJ, Tseng P, et al. Photorefractive HV. Postoperative complications in laser in situ keratokeratectomy for myopia of 6 to 12 D. J Refract Surg mileusis. Curr Opin Ophthalmol 2000; 11: ; 11(suppl):S286 S Gimbel HV, Anderson Penno EE, van Westenbrugge 19. Tuunanen TH, Tervo TT. Results of photorefractive JA, et al. Incidence and management of intraoperative keratectomy for low, moderate, and high myopia. J Retive and early postoperative complications in 1000 consecu- fract Surg 1998; 14: laser in situ keratomileusis cases. Ophthalmology 20. Azar DT, Ang RT, Lee J-B, et al. Laser subepithelial 1998; 105: ; discussion by TE Clinch, 1847 keratomileusis: electron microscopy and visual outcomes 1848 of flap photorefractive keratectomy. Curr Opin Ophtions 27. Stulting RD, Carr JD, Thompson KP, et al. Complica- thalmol 2001; 12: of laser in situ keratomileusis for the correction of 21. Litwak S, Zadok D, Garcia-de Quevedo V, et al. Laserassisted myopia. Ophthalmology 1999; 106:13 20 subepithelial keratectomy versus photorefractive keratectomy for the correction of myopia; a prospective From Balgensesang Ophthalmology Clinic (J.K. Kim, Lee), the Institute study. J Cataract Refract Surg 2002; 28: of Vision Research, Department of Ophthalmology, College of Medicine, Yonsei University (S.S. Kim, H.K. Lee, Seong, E.K. Kim, Han), and 22. Nakamura K, Kurosaka D, Bissen-Miyajima H, Tsubota BK 21 Project for Medical Science, Yonsei University (E.K. Kim), K. Intact corneal epithelium is essential for the preven- Seoul, Korea. tion of stromal haze after laser assisted in situ keratomileusis. Br J Ophthalmol 2001; 85: Supported by grant 02-PJ1-PG1-CH from the Korea Health 23. Sher NA, Hardten DR, Fundingsland B, et al. 193-nm 21 R&D Project, Ministry of Health and Welfare, Seoul, South Korea. excimer photorefractive keratectomy in high myopia. None of the authors has a commercial or proprietary interest in any Ophthalmology 1994; 101: material or method mentioned. J CATARACT REFRACT SURG VOL 30, JULY

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