Prospective randomized comparison of simultaneous and sequential bilateral laser in situ keratomileusis for the correction of myopia

OBJECTIVE: To study the safety and efficacy of simultaneous bilateral laser in situ keratomileusis (LASIK). DESIGN: Prospective randomized clinical trial. PARTICIPANTS: Fourteen surgeons and 714 consecutive eyes of 357 patients who desired surgical correction of myopia ranging from -2.00 to -22.50 diopters. INTERVENTION: Patients were randomized to simultaneous or sequential bilateral LASIK. MAIN OUTCOME MEASURES: Primary outcome measures were safety and efficacy. Procedure safety was assessed, for simultaneous and sequential groups, by comparison of intraoperative and postoperative complication rates and the percentage of eyes losing two or more lines of spectacle-corrected visual acuity. Procedure efficacy was assessed by comparison of the percentage of eyes with uncorrected visual acuity better than or equal to 20/20 and 20/40 and the percentage of eyes within +/-0.50 and +/-1.00 diopters of intended outcome. RESULTS: Three hundred seventy-eight eyes were enrolled in the simultaneous group, and 331 eyes were enrolled in the sequential group. Mean follow-up was 10 months (+/-4.2 months standard deviation; range, 2 weeks-22 months). There was no significant difference in intraoperative complication rate (P = 0.55), loss of two or more lines of spectacle-corrected visual acuity (P = 0.87), or percentage of eyes within +/-0.50 diopters of intended correction (P = 0.17) between simultaneous and sequential groups. Postoperative complications were not significantly different in the two groups except for the unexplained more frequent epithelial ingrowth in the simultaneous group (2.9%) than in the sequential group (0.6%). The adjusted odds ratio for epithelial ingrowth in the simultaneous group was 1.02 (95% confidence interval, 1.01-1.08). There was no increased likelihood of epithelial ingrowth in the second of two simultaneously treated eyes (P = 0.95). CONCLUSION: The outcomes and complications of performing bilateral simultaneous LASIK were not significantly different from those of sequential treatments, with the unexplained exception of more frequent epithelial ingrowth in the simultaneous group.     

Rehabilitation time after simultaneous bilateral photorefractive keratectomy for low to moderate myopia

PURPOSE: To evaluate the visual acuity rehabilitation time after simultaneous bilateral photorefractive keratectomy (PRK) using a flying small spot laser. SETTING: Eye Tech Medical Laser, Tel Aviv, Israel. METHODS: In this prospective interventional nonrandomized clinical trial, 42 consecutive eyes (21 patients) with myopia ranging from -0.75 to -5.50 diopters (D) (mean -2.75 D +/- 1.18 [SD]) and astigmatism up to -2.75 D (mean -0.64 +/- 0.55 D) were treated with bilateral simultaneous PRK using the ESIRIS excimer laser (Schwind). Main outcome measures were uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), and manifest refraction up to 12 weeks after surgery. Both eyes of each patient were examined at the same follow-up after initial treatment. RESULTS: Within 2 weeks and 1 month of the laser procedure, the UCVA was at least 20/40 in 1 eye in 85.7% of patients (18 patients) and 100% of patients (21 patients), respectively. After 2 weeks, UCVA was at least 20/20, 20/25, and 20/40 in 7.1%, 40.5%, and 80.9% of eyes. The final mean manifest spherical equivalent 12 weeks post laser treatment was -0.10 +/- 0.26 D, with a mean sphere of +0.02 +/- 0.22 D and a mean cylinder of -0.24 +/- 0.37 D. No eye had a BCVA loss during the follow-up. CONCLUSION: Simultaneous bilateral PRK using a flying small spot excimer laser for low to moderate myopia allowed most patients to return to most daily tasks in a couple of weeks without compromising safety.     

Prospective randomized comparison of wavefront-guided and conventional photorefractive keratectomy for myopia with the meditec MEL 70 laser

PURPOSE: To study refractive results and aberrometric changes in myopic patients treated with wavefront-guided photorefractive keratectomy (PRK) in comparison with standard PRK. METHODS: Sixty eyes of 60 patients with myopic astigmatism were randomly divided into two groups. Group 1 included 30 eyes (mean spherical equivalent refraction -4.39 +/- 1.31 D; range -2.50 to -6.50 D) treated with wavefront-guided PRK using the WASCA workstation and the Asclepion Meditec flying spot MEL 70 excimer laser. Group 2 had 30 eyes (mean spherical equivalent refraction -4.33 +/- 1.22 D; range -2.50 to -6.50 D) that underwent conventional PRK using the same laser, and served as the control group. Wavefront analysis of high order aberrations was performed before and 6 months after surgery. RESULTS: Postoperatively, wavefront error increased in both groups (5.0-mm wavefront aperture diameter). Six months after surgery, the eyes that received the WASCA ablation had a smaller increase in root-mean-square (RMS; 70% of increment) compared to the conventional PRK group (139% of increment) (P<.001). In the standard PRK group, all aberrations notably increased; in the wavefront-guided PRK group there was a smaller increase of trefoil and spherical aberrations (P<.001) and a decrease of coma aberrations (P<.001). The smaller increase of wavefront error in the wavefront-guided PRK group compared to the standard PRK group was more evident when preoperative RMS values were higher than 0.4 microm (P<.01). The visual parameters (spherical equivalent refraction, uncorrected and best spectacle-corrected visual acuity) did not show significant differences between the two groups. CONCLUSION: Wavefront-guided PRK induced a smaller increase of postoperative wavefront-error compared to conventional PRK, particularly in patients with higher preoperative higher order aberrations.     

PRK治疗近视术后角膜地形图分析

目的　分析准分子激光屈光性角膜切削术 (photorefractive keratectom y,PRK )治疗近视术后角膜表面形态及偏中心切削。方法　 76例 (1 5 0只眼 )行 PRK,术前屈光度 (- 3.0 0～ - 1 0 .0 0 ) D,平均 (- 6 .0 8± 1 .2 1 ) D。术后 1、3、6、1 2个月行角膜地形图检查。结果　角膜地形图形态分为平滑型、半圆型、钥匙孔型、肾型、中央岛型和不规则型 6种。角膜地形图形态有逐渐变平滑的趋势。术后 3个月以后 ,各种类型所占比例基本稳定。平滑型术后裸眼视力较好。偏中心距离 >0 .5 0 m m时 ,术后视力恢复不良。结论　角膜地形图分析系统能精确测量、分析全角膜的前表面形态 ,观察术后效果、指导手术设计 ,从而提高 PRK治疗近视的准确性、安全性和预测性     

Technical improvements in photorefractive keratectomy for correction of high myopia

PURPOSE: To evaluate the effects of hardware and software improvements in photorefractive keratectomy (PRK) for the treatment of highly myopic eyes. METHODS: A retrospective study was carried out in 554 patients (582 eyes) with myopia between -7.00 and -17.00 D (mean -11.20 +/- 3.60 D) who had undergone PRK using the Aesculap Meditec laser. Group 1 with a 5-mm-diameter single ablation zone; Group 2 with a 5-mm-diameter single zone surrounded by a 2-mm tapered transitional zone; Group 3 and Group 4, same as Group 2 but with the laser upgraded with a smoke aspiration control system (Group 3), and with a computer-controlled fluence (Group 4). RESULTS: In Group 1 at 2 years after PRK (50 eyes), 10 eyes (20%) were within +/-1.00 D of attempted correction and 13 eyes (26%) were within +/-2.00 D. In Group 2 at 2 years (118 eyes), 42 eyes (36%) were within +/-1.00 D of attempted correction and 65 eyes (55%) were within +/-2.00 D. In Group 3 at 2 years (43 eyes), 18 eyes (42%) were within +/-1.00 D of attempted correction and 28 eyes (65%) were within +/-2.00 D. In Group 4 at 2 years (47 eyes), 25 eyes (53%) were within +/-1.00 D of attempted correction and 29 eyes (62%) were within +/-2.00 D. CONCLUSIONS: Software and hardware improvements facilitated PRK correction of high myopia with reasonable predictability, especially if a tapered transition zone was used. At 12 and 24-month follow-up, only the use of a tapered transition zone was associated with a statistically significant improvement in predictability.     

Prospective, randomized, paired comparison of laser epithelial keratomileusis and photorefractive keratectomy for myopia less than -6.50 diopters

PURPOSE: We compared predictability, efficacy, safety, and patient satisfaction following laser epithelial keratomileusis (LASEK) and photorefractive keratectomy (PRK) for low to moderate myopia with either the Nidek EC-5000 excimer laser or the Technolas 217C excimer laser. METHODS: Forty-two patients with spherical equivalent refraction in the range -1.00 to -6.50 D were enrolled in this prospective study, each randomized for choice and sequence of LASEK and PRK on each of their eyes. Patients were examined daily for 7 days, and at 1 and 3 months. Patient satisfaction and quality of vision were assessed using a subjective questionnaire. RESULTS: Mean baseline refraction was -3.57 +/- 1.25 D in LASEK eyes and -3.44 +/- 1.13 D in PRK eyes. Follow-up rates were 100% up to 1 month and 76% at 3 months. At 3 months, 32 (100%) of LASEK eyes and 31 (97%) of PRK eyes had uncorrected visual acuity > or = 20/40, 25 (79%) of LASEK eyes and 26 (82%) of PRK eyes had uncorrected visual acuity > or = 20/20, mean refraction was 0.08 +/- 0.53 D in LASEK eyes and 0.12 +/- 0.50 D in PRK eyes, 26 (81%) of LASEK eyes and 23 (72%) of PRK eyes had a refraction within +/- 0.50 D and 29 (91%) of LASEK eyes and 30 (94%) of PRK eyes had refraction within +/- 1.00 D. Epithelial healing time and pain in LASEK and PRK eyes were not statistically different, and patients were equally satisfied. CONCLUSION: LASEK had similar predictability, efficacy, safety, and patient satisfaction to PRK in the treatment of low to moderate myopia.     

多区域准分子激光角膜切削术治疗近视

本文报导了多区域准分子激光角膜切削术治疗近视的疗效。１５０眼随访满６月，中低度近视组（≤－６．０Ｄ）８４眼，高度近视组（－６Ｄ～－１２Ｄ）６６眼。术后半年总体平均裸眼视力达到１．０７±０．２８；１４４眼（９６．０％）最终屈光度在±１．０Ｄ以内，其中中低度近视组８４眼（１００％）、高度近视组６０眼（９０．９％）。术后疗效高于单区域ＰＲＫ文献报导，尤其是高度近视术后稳定性及预测性明显提高     

准分子激光角膜上皮瓣下磨镶术与准分子激光屈光性角膜切削术治疗近视的比较

目的　研究准分子激光角膜上皮瓣下磨镶术 (LASEK)与准分子激光屈光性角膜切削术(PRK)在治疗 - 8 0 0D以下近视的异同。方法　 4 6例近视度数在 - 1 75～ - 8 0 0D的患者在双眼同时治疗时 ,其中一只眼行PRK治疗 ,另一只眼行LASEK治疗 ,观察上皮愈合时间 ,记载疼痛程度 ,对比术后 6个月内视力、屈光状态及角膜上皮下雾状混浊 (Haze)程度。结果　LASEK组上皮愈合时间平均为 3 4 9d ,PRK组为 2 87d ,两者差异有显著意义 (P <0 0 5 ) ;平均疼痛指数LASEK组为 2 0 4 ,PRK组为 2 4 5 ,差异有显著意义 (P <0 0 5 ) ;术后 6个月内两组间视力及屈光度恢复的差异无显著意义 (P>0 0 5 ) ,并发症的发生无差异。LASEK组术后Haze程度明显低于PRK组 (P <0 0 5 )。结论　LASEK可以和PRK一样安全有效地治疗低于 - 8 0 0D的近视 ,并且与PRK相比 ,可以降低早期疼痛水平 ,减少Haze并发症的发生。     

准分子激光角膜切削术治疗近视的并发症

为分析准分子激光角膜切削术（ＰＲＫ）治疗近视的并发症，对１３９例（２５７眼）ＰＲＫ术后随访半年至一年。结果表明：术后一年，低中度和高度组各有１眼最佳矫正视力丢失二行，分别占２．５％和３．３％；低中度和高度组的角膜上皮下１级混浊分别为１０．８１％和１５．１６％，２级混浊分别为２．７３％和０％；激素性高眼压，在发生率最高的３个月时，可分别达２４．３７％和２５．３２％，但这种反应性的眼压升高只是暂时的，容易控制；过矫和散光增加的发生率均较低，主要与术者的经验有关。随着术者经验的提高、手术设计的完善及术后用药的研究，这些并发症会降到最低水平。ＰＲＫ是安全、有效的。     

Laser-assisted subepithelial keratectomy versus photorefractive keratectomy for the correction of myopia. A prospective comparative study

PURPOSE: To compare the early postoperative visual rehabilitation after laser-assisted subepithelial keratectomy (LASEK) and photorefractive keratectomy (PRK) for the correction of myopia. SETTING: CODET Aris Vision Institute, Tijuana, Mexico. METHODS: This prospective study included 50 eyes of 25 patients with myopia who received LASEK in 1 eye and PRK in the contralateral eye. Excimer laser corneal ablation was done using the Nidek EC-5000 excimer laser. Patients were seen at 1 and 3 days, 1 week, and 1 month. Discomfort, subjective uncorrected visual acuity (UCVA), objective UCVA, best corrected visual acuity (BCVA), corneal clarity (haze), and time for corneal reepithelialization were analyzed. RESULTS: Seventy-two percent and 80% of the LASEK eyes had more discomfort at 1 day and 3 days, respectively. Eighty percent and 96% of the PRK eyes had better subjective UCVA at 1 day and 3 days, respectively. Corneas were fully reepithelialized at a mean of 3.3 days +/- 0.5 (SD) and 3.6 +/- 0.5 days in the PRK and LASEK groups, respectively. At 1 month, the UCVA was similar in both groups; no eye had lost lines of BCVA or developed haze. CONCLUSIONS: Both LASEK and PRK were effective and safe procedures in the surgical correction of myopia at the 1-month postoperative visit. Patients reported less discomfort and better visual acuity in their PRK eye during the early postoperative period. Patients should be informed that LASEK, whose acronym is similar to that of laser in situ keratomileusis, has a recovery speed that is similar to that of surface laser refractive procedures such as PRK.     

LASEK and photorefractive keratectomy for myopia: clinical and confocal microscopy comparison

PURPOSE: To compare postoperative visual acuity and corneal morphology after laser epithelial keratomileusis (LASEK) versus photorefractive keratectomy (PRK) in the correction of low to moderate myopia. METHODS: In a double-blind, randomized clinical trial, 50 myopic patients (mean: -4.5 +/- 1.35 diopters) were randomized to receive LASEK in one eye and PRK in the fellow eye. No mitomycin C eye drops were used in this study. Patients were observed daily for 4 days, then at 1 month and every 3 months up to 1 year. Uncorrected and best-corrected visual acuity (UCVA and BSCVA), manifest refraction, corneal epithelium healing time, postoperative pain, and corneal haze were evaluated. Corneal wound healing was quantified with corneal confocal microscopy. RESULTS: Refractive error, UCVA, and BSCVA were not statistically different between eyes treated with LASEK and PRK. Corneal epithelium healing time was 2.52 +/- 0.99 days in the eyes treated with PRK and 2.29 +/- 0.52 days in the eyes treated with LASEK (P=.22). The postoperative pain score was 2.17 +/- 0.87 in the eyes treated with PRK and 2.62 +/- 0.60 (P=.02) in the eyes treated with LASEK. Corneal confocal microscopy showed fewer stromal activated keratocytes and less extracellular matrix deposition in the eyes treated with LASEK than in the eyes treated with PRK at 1 month postoperatively (P=.003). CONCLUSIONS: LASEK is an effective and safe procedure for low to moderate myopia, but it seems more painful until full corneal reepithelization. In the early postoperative period, the corneal wound healing process is significantly less intense in eyes treated with LASEK than in eyes treated with PRK. The role of LASEK in corneal wound healing modulation remains controversial.     

Five-year follow-up of photorefractive keratectomy for myopia

PURPOSE: To analyze long-term results of photorefractive keratectomy (PRK) for myopia and myopic astigmatism. METHODS: This retrospective study included 15 eyes of 8 patients who were examined annually for 5 years after PRK. The Nidek EC-5000 laser with an ablation zone of 5.0 mm was used. Evaluations included spherical equivalent manifest refraction, uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), corneal haze, and corneal astigmatism calculated by Fourier analysis of videokeratography data. RESULTS: A tendency toward myopic regression was most evident within the first postoperative year, with manifest refraction changing from +0.80 +/- 1.62 D at 1 week to -0.45 +/- 0.70 D at 1 year postoperatively (P = .007). Regression continued after the second postoperative year. There was a statistically significant difference between manifest refraction at 2 years (-0.36 +/- 0.75 D) and 5 years (-1.11 +/- 1.12 D) (P = .002). Postoperative UCVA stabilized from 3 months up to 3 years, but slightly deteriorated at 4 years and thereafter due to the myopic refractive shift. BSCVA remained stable throughout the 5-year follow-up period. Several eyes developed mild corneal haze after surgery, but haze was minimal in the majority of patients by 1 year and continued to fade over time. The asymmetry component of the cornea significantly increased after surgery, with all postoperative values significantly higher than before PRK (P < .05). Higher order irregularity increased after surgery, with a statistically significant difference between preoperative and 1 year postoperative (P < .05), but values after 2 years were not different from preoperative baseline. CONCLUSION: Fifteen eyes with a baseline refraction of -3.00 to -9.00 D had PRK with the Nidek EC-5000 laser and a 5-mm-diameter ablation zone. Myopic regression occurred in the first year, with continued mild regression of approximately -0.75 D between 2 and 5 years. Nevertheless, the results show the procedure was relatively safe and effective in this group.     

Eight-year follow-up of photorefractive keratectomy for myopia

PURPOSE: We evaluated 8-year results of excimer laser photorefractive keratectomy (PRK) for myopia in terms of stability and late complications. METHODS: Ninety-two myopic eyes of 55 patients were treated with a single-step method using an Aesculap-Meditec MEL 60 excimer laser with a 5.0-mm ablation zone. Treated eyes were divided into three groups according to preoperative refraction: low myopes (< or = -6.00 D), medium myopes (-6.10 to -10.00 D), and high myopes (>-10.00 D). RESULTS: Change in myopic regression stabilized in all myopia groups within 12 months, although a small myopic shift occurred up to 8 years after PRK. Mean change in refraction between 2 and 8 years was -0.42 +/- 0.48 D for low myopes, -0.37 +/- 0.34 D for medium myopes, and -0.41 +/- 0.50 D for high myopes. The percentage of eyes within +/- 1.00 D of emmetropia 8 years after PRK was 78.3% in the low myopia group, 68.8% in the medium myopia group, and 57.1% in the high myopia group. One eye lost 2 lines of best spectacle-corrected visual acuity due to irregular astigmatism. In 13.0% of eyes, a residual trace corneal haze was observed, which had no effect on visual acuity. Apart from the loss of 2 lines of BSCVA in one eye, there were no other late complications during the study period. CONCLUSIONS: The mean change in refraction between 2 and 8 years was less than -0.50 D, regardless of preoperative refraction, and may be attributed to natural age-related refractive change. The appearance of residual corneal haze after 8 years correlated with the amount of myopic correction. PRK was a safe and stable surgical procedure in this group of patients.     

准分子激光二次切削治疗近视性角膜切削术后欠矫

本研究共１５人（２３眼）于准分子激光角膜切削术后因欠矫而实施二次切削。术前平均屈光度为－９．８６Ｄ（－５．００—－２０．００Ｄ），其中２眼为中度近视（－３．２５—－６．００Ｄ），６眼为高度近视（－６．２５—－９．００Ｄ），１５眼为超高度近视（≥－９．２５Ｄ）。准分子激光二次切削采用治疗性角膜切削术（ＰＴＫ）和光学性角膜切削术（ＰＲＫ）相结合的方法。术后６个月随访结果表明：９１％的裸眼视力≥０．５，７０％的裸眼视力≥１．０，７０％的屈光度在±１．００Ｄ，角膜无明显混浊。由此证明：准分子激光二次切削治疗近视性角膜切削术后欠矫及角膜混浊是有效的。     

Ten-year follow-up of photorefractive keratectomy for myopia

Background  

The aim of this study is to evaluate the long-term (10-year) outcome of excimer laser photorefractive keratectomy (PRK) on myopic eyes.     

Randomized bilateral comparison of excimer laser in situ keratomileusis and photorefractive keratectomy for 2.50 to 8.00 diopters of myopia

OBJECTIVE: To compare effectiveness, safety, and stability of excimer laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) for low-to-moderate myopia. DESIGN: Prospective, randomized, bilateral study. PARTICIPANTS: Thirty-three patients with a manifest refraction of -2.50 to -8.00 diopters (D) participated. INTERVENTION: For each patient, one eye received LASIK and the other received PRK. The first eye treated, and surgical method in the first eye, were randomized. Both eyes were treated by the same surgeon during the same operative session with a Summit Omnimed I laser (6-mm-diameter ablation) and a Chiron Automated Corneal Shaper. Follow-up was 90% at 1 and 2 years. RESULTS: At baseline, mean (+/-standard deviation) spherical equivalent manifest refraction was -4.80 +/- 1.60 D in LASIK-treated eyes and -4.70 +/- 1.50 D in PRK-treated eyes. At 1 day after surgery, 81% of patients (21 eyes) reported no pain in the LASIK-treated eye, whereas no patient (0%) reported being pain-free in the PRK-treated eye. At 3 to 4 days after surgery, 18 (80%) LASIK-treated eyes either improved or remained within 1 line of baseline spectacle-corrected visual acuity; only 10 (45%) PRK-treated eyes achieved this result. At 2 years after surgery, 18 (61%) LASIK- and 10 (36%) PRK-treated eyes achieved an uncorrected visual acuity of 20/20 or better, with no statistically significant difference in refractive outcome between the two techniques. Quantitative videokeratography showed more regularity after LASIK. Complications were similar in the two groups. Patients preferred LASIK by a margin of 2 to 1 at 1 year but showed no preference at 2 years. CONCLUSIONS: Using a 6-mm-diameter single-pass, large area ablation and an automated microkeratome to treat myopia of -2.50 to -8.00 D with 1.00 D or less astigmatism in 1994, the authors used LASIK to produce a higher percentage of eyes with an uncorrected visual acuity of 20/20 or better, more regular postoperative corneal topography, less postoperative pain, and more rapid recovery of baseline spectacle-corrected visual acuity than PRK. Both LASIK and PRK achieved successful correction of low-to-moderate myopia at 1 and 2 years after surgery.     

Stray light in photorefractive keratectomy for myopia

We performed a study to evaluate the influence on visual function of intraocular straylight after photorefractive keratectomy (PRK). We present 4 eyes of 4 myopic individuals, who had contacted our clinic for keratorefractive surgical treatment. PRK's were performed with a Summit laser, using a 5 mm ablation zone. The straylight meter was used to measure the amount of intraocular scattered light, the physical cause of glare complaints, before and after PRK. This apparatus uses the direct compensation method to assess the amount of intraocular light scatter. The results showed a significant increase in straylight values, in the tested eyes, during the first two weeks after PRK. After the initial rise, straylight values returned to preoperative levels, except for two eyes that clearly developed a haze higher than grade two. Instead of returning to baseline levels, straylight values remained significantly higher in these eyes.