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  5. 近视激光手术的长期队列研究：复发与并发症

近视激光手术的长期队列研究：复发与并发症

文献检索匿名用户发表于 2026年03月06日 16:0822阅读
检索问题

请找关于近视激光手术的长期队列研究，近视复发、并发症等情况如何？

关于近视激光手术（如全飞秒 SMILE、半飞秒 LASIK、表层手术 PRK 等）的长期效果，结论非常明确：这类手术在长达 10 到 17 年的追踪研究中显示出极高的安全性，视力保持效果普遍稳定，严重的视力回退或致盲性并发症非常罕见。

虽然“手术做了十几年后会不会瞎”是很多人的担忧，但目前的医学证据表明，这种担心是多余的。大多数人在手术多年后依然拥有良好的裸眼视力。当然，确实存在极少数人会出现轻微的度数回退（近视复发），或者干眼等并发症，但通常都在可控范围内。

下面我将根据多项长期追踪研究的证据，为您详细拆解“近视复发”和“并发症”这两个核心问题。

1. 做了手术，过几年近视会“反弹”吗？（关于复发与回退）

首先要纠正一个概念：手术后的度数变化通常被称为屈光回退（Refractive Regression）。这并不是说你的近视治好了又完全变回去了，而是在原本矫正好的基础上，眼睛又出现了一点点近视度数。

核心结论： 绝大多数人的视力非常稳定，只有极少数人会出现轻微的回退，而且回退的幅度通常很小，不影响日常生活。

  • 长期稳定性数据惊人：

    • 一项针对军人长达 17年 的研究显示，做过 LASIK（半飞秒）或 PRK（表层手术）的人，平均每年近视度数的增长不到 10度（0.1D）。也就是说，哪怕过了十年，你的度数变化可能还不到一只隐形眼镜度数的一半 。
    • 另一项针对 SMILE（全飞秒）手术 10年 的追踪发现，10年后平均的回退度数仅为 35度（0.35D），这个幅度在临床上几乎可以忽略不计 。
    • 还有研究显示，SMILE 手术后 5 年，接近 70% 的眼睛度数变化都在 50度 以内，非常稳定 。

  • 哪些人更容易“反弹”？ 虽然整体稳定，但确实有几类人风险稍高：

    1. 高度近视患者： 如果你术前度数很高（比如超过 1000度），手术切削的角膜组织多，回退的概率会比中低度近视的人大。一项研究对比了不同度数的人群，发现术前超过 1000 度的高度近视者，术后回退更明显 。
    2. 越年轻做手术风险越高： 研究发现，年龄每增加一岁，回退风险就降低一点。年轻人的眼球可能还在发育变化中，不够稳定。特别是 21 岁以下的年轻人，如果角膜比较薄，术后更容易出现回退 。
    3. 用眼习惯差的人： 这点非常重要。针对飞行员的研究发现，那些经常连续近距离用眼超过 45 分钟的人，术后近视回退的风险显著增加 。换句话说，手术只是把目前的近视“清零”，如果你术后天天通宵打游戏、不休息，眼睛还是会再次近视的。

  • 万一回退了怎么办？ 极少数出现回退的人，如果角膜厚度允许，是可以进行二次增效手术（Retreatment）的。不过随着技术进步，现在需要二次手术的人越来越少。数据显示，2005 年时 PRK 手术的二年重做率还有 6.17%，到了 2012 年已经降到了 0.1% 。

2. 手术后会有后遗症或并发症吗？（关于安全性）

很多人担心手术会破坏眼球结构，老了以后出问题。证据显示，严重的长期并发症极其罕见。

  • 干眼症（眼睛干涩）： 这是术后最常见的抱怨，但通常是暂时的。

    • 全飞秒（SMILE）优势明显： 因为全飞秒手术切口极小（只有 2-4毫米），对角膜表面的神经损伤更小。多项研究表明，相比于半飞秒（LASIK），全飞秒术后干眼症状更轻，恢复得更快 。
    • 对于大部分患者，干眼症状会在术后 3-6 个月内逐渐缓解。

  • 角膜扩张（Ectasia）： 这是最令人恐惧的并发症，指角膜变得太薄、太软，像圆锥一样凸起，导致视力严重下降。

    • 极度罕见： 在现代严格的术前筛查下，这种情况发生的概率极低。一项长达 10 年的追踪研究显示，在接受全飞秒手术的患者中，没有发现一例角膜扩张 。
    • 高度近视需谨慎： 只有极少数超高度近视（如 2800度）且切削过多的极端案例中才出现过这种情况。现在的医生在术前会严格计算，如果剩余角膜厚度不够（通常要保留一定厚度的安全基质床），医生会直接拒绝给你做激光手术，转而推荐 ICL 晶体植入术，从而规避了这种风险 。

  • 角膜混浊（Haze）： 这主要出现在 PRK（表层手术）中，表现为角膜变得有点“雾蒙蒙”。

    • 现在的技术配合药物（如丝裂霉素C）和术后激素眼药水，已经能很好地预防这种情况。研究显示，即使是高度近视做表层手术，角膜混浊也会随着时间推移逐渐消退 。

  • 夜间视力问题（眩光/光晕）： 早期的激光手术确实容易导致晚上看灯有光圈。但现代技术（如波前像差引导）已经大大改善了这一点。长期研究表明，术后长期的夜间视觉质量与术前相比并没有显著恶化，甚至有些指标还优于术前 。

3. 三种主流手术方式，长期来看谁更好？

目前主流的激光手术主要有三种：

  • PRK/表层手术： 不切角膜瓣，直接刮掉一层皮打激光。
  • LASIK/半飞秒： 先切开一个盖子（瓣），打完激光再盖回去。
  • SMILE/全飞秒： 既不掀盖子也不刮皮，直接用激光在角膜里面制作一个微透镜，从一个小口取出来。

长期对比结论： 三者在长期的视力效果上打成平手。

  • 一项回顾了 440 篇文章的综述指出，不管是做了 10 年以上的 PRK 和 LASIK，还是做了 5 年以上的 SMILE，它们在最终的视力清晰度上没有明显差异 。
  • SMILE 的独特优势： 虽然视力结果一样，但全飞秒（SMILE）因为切口小，角膜生物力学稳定性可能更好，术后干眼更少，角膜神经恢复更快 。如果你平时喜欢剧烈运动（如打篮球、拳击），SMILE 会更安全，因为它没有角膜瓣移位的风险。
  • 表层手术（PRK/LASEK）的价值： 对于角膜比较薄的人，表层手术依然是很好的选择。一项针对角膜薄（小于 500微米）患者的研究发现，做表层手术或 LASIK 后，长期视力依然安全稳定，并没有因此这就容易“瞎” 。

4. 总结与建议

基于目前的科学证据，我们可以放心地说：

  1. 长期非常安全： 激光近视手术不是“年轻时爽，老了瞎”，即使过了 10-17 年，绝大多数人的视力依然保持得很好 。
  2. 度数极其稳定： “反弹”是小概率事件，且幅度很小。只要你成年了、近视度数稳定了再做手术，并且术后不要疯狂用眼，基本不用担心 。
  3. 技术在进步： 现在的全飞秒（SMILE）技术在保持视力的同时，减少了干眼等不适感，体验比十几年前的技术更好 。

给您的建议：

  • 术前检查是关键： 手术安不安全，一半看医生的刀，一半看你的眼。严格的术前检查（角膜厚度、形态等）能排除掉绝大部分风险（如圆锥角膜倾向）。如果医生说你的条件不适合做激光，千万不要强求，可以考虑 ICL 晶体植入。
  • 术后保养不能丢： 手术只是帮你摘掉了眼镜，没有改变你近视眼的本质（眼轴已经变长了）。术后依然要控制近距离用眼时间，避免视疲劳，这是防止“反弹”的最有效手段 。
References

1[Long-term outcomes of PRK, LASIK and SMILE].PubMed

Suphi Taneri, Jennifer Knepper, Anika Rost, et al.
Ophthalmologe. 2022 Feb;119(2):163-169. doi: 10.1007/s00347-021-01449-7. Epub 2021 Jul 9.
BACKGROUND: Patients and refractive surgeons have a legitimate interest in the long-term results of the most commonly used laser procedures for correction of ametropia. OBJECTIVE: To assess the safety, predictability, stability and late complications according to the current recommendations of the committee for refractive surgery (KRC). METHODS: Literature search in PubMed with the search term "long-term outcome" combined with either "PRK", "LASIK" or "SMILE". Articles about PRK and LASIK with a minimum follow-up of 10 years and SMILE with a minimum follow-up of 5 years were evaluated and duplications were eliminated. RESULTS: From a total of 440 articles that matched these search terms 15 articles were selected and analyzed. The results of PRK were described in 4 studies with a total of 666 eyes, 7 studies (566 eyes) described the results of LASIK and 5 studies (188 eyes) the results after SMILE. CONCLUSION: Long-term studies with follow-up periods of at least 10 years have shown that PRK and LASIK treatment carried out in the early days of medical excimer lasers have a very high level of safety and late complications occurred only rarely. The effectiveness of particularly high corrections declined over time. In contrast, there was no clinically significant regression within the indications recommended by the KRC. The results of SMILE were not inferior to those of PRK and LASIK. In direct long-term comparisons no procedure showed a clear superiority. Due to technological improvements in hardware and software for both preoperative diagnostics and lasers, treatment performed nowadays is presumably even safer, more efficient and also more stable over a long period of time.

2Refractive regression after laser in situ keratomileusis.PubMed

Mabel K Yan, John Sm Chang, Tommy Cy Chan
Clin Exp Ophthalmol. 2018 Nov;46(8):934-944. doi: 10.1111/ceo.13315. Epub 2018 May 17.
Uncorrected refractive errors are a leading cause of visual impairment across the world. In today's society, laser in situ keratomileusis (LASIK) has become the most commonly performed surgical procedure to correct refractive errors. However, regression of the initially achieved refractive correction has been a widely observed phenomenon following LASIK since its inception more than two decades ago. Despite technological advances in laser refractive surgery and various proposed management strategies, post-LASIK regression is still frequently observed and has significant implications for the long-term visual performance and quality of life of patients. This review explores the mechanism of refractive regression after both myopic and hyperopic LASIK, predisposing risk factors and its clinical course. In addition, current preventative strategies and therapies are also reviewed.

3Postoperative Corneal Complications in Small Incision Lenticule Extraction: Long-Term Study.PubMed

Yan Wang, Jiaonan Ma, Lin Zhang, et al.
J Refract Surg. 2019 Mar 1;35(3):146-152. doi: 10.3928/1081597X-20190118-02.
PURPOSE: To investigate the incidence and clinical results of corneal complications after small incision lenticule extraction (SMILE). METHODS: A retrospective cohort study including 3,223 patients (6,373 eyes) who were treated for myopia or myopic astigmatism was conducted. Postoperative corneal complications were recorded. Postoperative follow-up visits were scheduled on days 1 and 7 and months 1, 3, 6, and 12. RESULTS: Of the 6,373 cases, 432 eyes (6.8%) developed at least one corneal complication postoperatively. These included punctate epithelial erosions (3.26%), diffuse lamellar keratitis (DLK) (2.17%), corneal infiltrates (0.39%), interface debris/secretion (0.30%), interface haze (0.17%), interface foreign body (0.24%), corneal striae (0.14%), corneal edema (0.09%), and epithelial ingrowth (0.02%). Of cases with corneal complications, 308 (71.3%) had an uncorrected distance visual acuity (UDVA) of better than 20/25 and 49 (11.3%) eyes lost two or more lines of corrected distance visual acuity (CDVA) on the first day after surgery. By 3 months, only 2 eyes (0.9%) had lost two or more lines of CDVA. At 6 months, 1 eye (1.0%) did not achieve a UDVA of 20/25 as a result of stage 3 DLK, but achieved 20/20 by 1 year. The postoperative spherical equivalent in cases without complications was lower than that in cases with complications at 1 day and 1 and 3 months (P = .001, .011, and .001, respectively), but there was no statistical difference at 6 and 12 months. CONCLUSIONS: In this large cohort study, a variety of corneal complications were noted after SMILE. Although some of these complications may temporarily affect visual recovery, most resolve with appropriate treatment. [J Refract Surg. 2019;35(3):146-152.].

4Long-Term Outcomes of Refractive Surgery Performed During the Military.PubMed

Roxana Y Godiwalla, M Teresa Magone, Sandor B Kaupp, et al.
Mil Med. 2019 Dec 1;184(11-12):e808-e812. doi: 10.1093/milmed/usz096.
INTRODUCTION: To evaluate the long-term refractive results of laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) performed by the military in a veteran population. MATERIALS AND METHODS: Three Department of Veterans Affairs (VA) hospital sites (Puget Sound, Buffalo, and Washington D.C.) obtained IRB approval for this multi-center study. Comprehensive ophthalmologic assessment including refraction and keratometry were obtained at the time of the long-term VA examination and compared to the patients' postoperative military records. RESULTS: Eighty patients (160 eyes) enrolled in this study. At the time of treatment, patients were 21-52 years of age. Long-term post-operative data was available from 4 to 17 years post-operatively. Fifteen percent of the treatment types were LASIK and 85% PRK. At the time of their military post-operative exam (range 3-14 months, mean 4 months), 82% of patients had uncorrected visual acuity (UCVA) of 20/20 or better, and their average manifest refraction was -0.08 D (SD ± 0.48 D). At the time of the long-term ophthalmological exam at the VA medical centers (range 4-11 years, mean of 8.2 years), 49% of patients had an UCVA of 20/20 or better and an average manifest refraction was -0.64 D (SD ± 0.69 D). CONCLUSION: This is the first long-term study evaluating refractive surgery outcomes up to 17 years in a military population. Our study demonstrates safety after refractive surgery in the military with less than 0.1D increase in myopia per year and strong keratometric stability. Other changes in the eye may be the likely cause for this observed mild refractive shift.

5History and Results; Indications and Contraindications of SMILE Compared With LASIK.PubMed

Rupal Shah
Asia Pac J Ophthalmol (Phila). 2019 Sep-Oct;8(5):371-376. doi: 10.1097/01.APO.0000580132.98159.fa.
Small incision lenticule extraction (SMILE) is a new paradigm for refractive surgery, and was first performed by Sekundo and Blum in 2008. It uses only a femtosecond laser to carve out a lenticule within the corneal stroma, and then achieves refractive correction by extracting the lenticule through a small incision. A number of studies have shown that SMILE leads to stable and efficacious outcomes, combined with high safety. Long-term studies also indicate that SMILE has excellent outcomes combined with high safety. Although relatively safe, SMILE can have some intraoperative and postoperative complications, including suction loss during the procedure, lenticule tears, incision tears, epithelial ingrowth, diffuse lamellar keratitis, and residual refractive error. Studies indicate that SMILE leads to less postoperative dry eyes. It is thus preferred over laser-assisted in-situ keratomileusis (LASIK) in cases wherein there is mild dry eye preoperatively. It is also preferred over LASIK in cases wherein the patient is likely to engage in contact sports. LASIK may be preferred over SMILE for the treatment of hyperopia, and in cases of significant higher order wavefront aberrations or topographic irregularities.

6Analysis on the Correlation Between Long-term Refractive Regression and Visual Quality after FS-LASIK.PubMed

Mingyue Zhang, Xin Li, Qingjun Hu
Curr Eye Res. 2022 Jun;47(6):824-831. doi: 10.1080/02713683.2022.2035402. Epub 2022 Mar 14.
PURPOSE: To record the long-term visual quality after FS-LASIK and analyze the effect of long-term refractive regression after corneal laser surgery on visual quality. METHODS: Seventy-eight patients (153 eyes) who had undergone FS-LASIK more than 5 years before and had undergone follow-ups between November 2020 and March 2021. We collected data on the patients' age of surgery, postoperative period, and preoperative diopters (corrected to LogMAR 0.0 by mydriatic optometry). We obtained the measurements of ARC, PRC, THP by Pentacam, and extracted values for UCVA(LogMAR), CTRmsTotal, CTRmsHO, RmsTotal, RmsHO, MTFTotal, MTFHO, PSFTotal, PSFHO, Coma-T, Coma-CT, SA-T, SA-CT, Trefoil-T, and Trefoil-CT measured with OPD Scan III. We allocated the patients into emmetropia group (SE≤ -0.5 D) 40 patients (78 eyes) and regression group (SE > -0.5D) 38 patients (75 eyes) based on their postoperative diopters. RESULTS: The values for postoperative periods, preoperative diopters, CTRmsTotal, CTRmsHO, and RmsTotal, Coma-CT, CTSA-CT in the emmetropia group were significantly lower than those in the regression group. The age of surgery, UCVA, MTFTotaL, MTFHO, PSFTotal, and CTPSF values in the emmetropia group were significantly higher than those in the regression group. The ARC, PRC, THP, RmsHO, Coma-T, SA-T, Trefoil-T, and Trefoil-CT values were similar in both groups. There was no significant difference in preoperative sphere, spherical equivalent and BCVA between the two groups. There were significant differences in postoperative parameters at 1 year, 3 years, and 5 years. The postoperative diopter value was significantly correlated with age of surgery, postoperative period, THP, MTFTotal, PSFTotal, Coma-T, and SA-CT. CONCLUSION: After FS-LASIK, young patients with relatively thin cornea are susceptible to refractive regression. With the extension of postoperative period, refractive regression may aggravate. There was no significant correlation between postoperative refractive regression and higher order aberrations.

7Long-term efficacy and safety profiles following small incision lenticule extraction in eyes with ≥ 5-year follow-up.PubMed

Mario Renato Papa-Vettorazzi, José Luis Güell-Villanueva, José Benjamín Cruz-Rodriguez, et al.
Eur J Ophthalmol. 2022 Nov;32(6):3333-3339. doi: 10.1177/11206721221077541. Epub 2022 Feb 1.
PURPOSE: To evaluate long-term efficacy, safety, predictability and stability (refractive and keratometric) of myopic and myopic astigmatism correction with Small Incision Lenticule Extraction (SMILE). METHODS: Single center retrospective review of eyes undergoing SMILE from 2012-2015. Forty-two eyes (23 patients) with ≥ 5-year follow-up. Variables analyzed were preoperative, 3-month, 1-year and last follow-up uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction, spherical equivalent (SE) and mean keratometry. Descriptive statistics were performed and results reported following the Standard for Reporting Astigmatism Outcomes. RESULTS: Mean follow-up of 5.98 ± 0.90 years. Mean preoperative SE was -5.26 ± 1.22D (range -2.50 to -8.12D). Mean preoperative cylinder was -0.66 ± 0.61D (range 0.00 to -2.25D). Efficacy and safety indices were 0.86 and 0.98, respectively. In total, 81% of operated eyes achieved an UDVA of ≥ 0.09 logMar (20/25 Snellen). At the last follow-up, ≥1 line of CDVA was gained in 14% of eyes. Five percent lost 1 line of CDVA, and no eye loss ≥2 lines of CDVA. Sixty-nine percent of eyes were within ± 0.50D and 86% within ± 1.00D of the attempted SE correction. Ninety-one percent of eyes had ≤0.50D of postoperative astigmatism and 71% were within ± 15° from the intended correction axis. At the final follow-up, a statistically significant myopic regression of 0.19 ± 0.50D was observed (p = 0.01). CONCLUSIONS: Long-term results demonstrate that SMILE is effective, predictable and safe. SMILE has good stability, low regression compared to LASIK, and no signs of corneal ectasia staging within our standard criteria.

8Factors affecting long-term myopic regression after corneal refractive surgery for civilian pilots in southwest China.PubMed

Zhen Zhang, Lan Xi Xiang, Ye Wu, et al.
BMC Ophthalmol. 2024 Apr 2;24(1):145. doi: 10.1186/s12886-024-03399-5.
BACKGROUND: The purpose of this study was to analyze myopic regression after corneal refractive surgery (CRS) in civilian pilots and to explore the factors that may cause long-term myopic regression. METHODS: We included civilian pilots who had undergone CRS to correct their myopia and who had at least 5 years of follow-up. We collected retrospective data and completed eye examinations and a questionnaire to assess their eye habits. RESULTS: A total of 236 eyes were evaluated in this study. 211 eyes had Intrastromal ablations (167 eyes had laser in situ keratomileusis, LASIK, 44 eyes had small incision lenticule extraction, SMILE) and 25 eyes had subepithelial ablations (15 eyes had laser epithelial keratomileusis, LASEK and 10 eyes had photorefractive keratectomy, PRK). The mean preoperative spherical equivalent (SE) was - 2.92 ± 1.11 D (range from - 1.00 to -5.00 D). A total of 56 eyes (23.6%) suffered from myopic regression after CRS. Comparisons of individual and eye characteristics between the regression and non-regression groups revealed statistically significant differences in age, cumulative flight time, postoperative SE (at 6 months and current), uncorrected visual acuity (UCVA), accommodative amplitude (AA), positive relative accommodation (PRA), postoperative period, types of CRS and eye habits. Generalized propensity score weighting (GPSW) was used to balance the distribution of covariates among different age levels, types of CRS, cumulative flying time, postoperative period and continuous near-work time. The results of GPS weighted logistic regression demonstrated that the associations between age and myopic regression, types of CRS and myopic regression, continuous near-work time and myopic regression were significant. Cumulative flying time and myopic regression, postoperative period and myopic regression were no significant. Specifically, the odds ratio (OR) for age was 1.151 (P = 0.022), and the OR for type of CRS was 2.769 (P < 0.001). The OR for continuous near-work time was 0.635 with a P value of 0.038. CONCLUSIONS: This is the first report to analyze myopic regression after CRS in civilian pilots. Our study found that for each year increase in age, the risk of civilian pilots experiencing myopic regression was increased. Intrastromal ablations had a lower risk of long-term myopia regression than subepithelial ablations. There is a higher risk of myopic progression with continuous near-work time > 45 min and poor accommodative function may be related factors in this specific population.

9Short and long term outcomes after small-incision lenticule extraction: A tertiary referral centre experience.PubMed

C Yesilkaya, M Arıcı, Y Yıldırım, et al.
J Fr Ophtalmol. 2020 Oct;43(8):753-760. doi: 10.1016/j.jfo.2019.11.020. Epub 2020 Jun 30.
PURPOSE: The objective of this study is to evaluate the preoperative and short- and long-term postoperative results in terms of visual acuity, refractive error, and corneal wavefront aberrations in patients with myopia and myopic astigmatism undergoing small incision lenticule extraction (SMILE). METHODS: Seventy-nine eyes of 52 myopes with or without astigmatism (41 right and 38 left) were enrolled in this retrospective study. The measurements included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), spherical equivalent (SE) and wavefront aberrations. All the measurements before and after SMILE surgery were systematically recorded. RESULTS: Mean preoperative UDVA was 1.19±0.24 logMAR and improved to 0.06±0.17 logMAR at the 3-year postoperative follow-up. At the conclusion of the 3-year follow-up, UDVA was better than or equal to 20/20 and 20/25 in 73% and 84% of eyes, respectively. At 1 month postoperatively, CDVA was 0.05±0.23 logMAR and significantly lower than the preoperative CDVA, 0.02±0.04 log MAR (P>0.05). However, at 1 year and 3 years after surgery, CDVA showed a significant increase compared to preoperative CDVA. At the conclusion of the 3-year follow-up, SE was -0.47 D, and 69.6% and 83.5% of the eyes were within±0.50 D and±1.00 D, respectively, of the intended correction. HOA's, coma, and spherical aberration increased significantly. No significant change in trefoil was detected. CONCLUSION: This study showed that SMILE produces a stable, safe outcome for surgical treatment of myopia and myopic astigmatism.

10Long-term outcome of epi-LASIK for high myopia.PubMed

Shiyuan Wang, Jinhui Dai, Renyuan Chu, et al.
Eur J Ophthalmol. 2012;22 Suppl 7:S98-105. doi: 10.5301/ejo.5000025.
PURPOSE: To evaluate the long-term outcomes of epipolis laser-assisted in situ keratomileusis (epi-LASIK) for high myopia. METHODS: High myopic patients who underwent epi-LASIK during 2004 and 2005 were included in this study. Epi-LASIK was performed with an automatically rotational epikeratome (KM-5000D). Postoperative visual acuity, manifest refraction, and haze formation were assessed 3 mo, 6 mo, 1 y, and 3 y after surgery. Results were compared by dividing patients into 2 groups according to preoperative mean refractive spherical equivalent (MRSE): group A (≥-6 D to -10 D; group B ≥-10 D). The differences within groups were analyzed using mixed model for continuous variables. The differences between groups were analyzed using t test or rank sum test for continuous variables, and Pearson χ² or Fisher exact probabilities for categorical variables. RESULTS: A total of 20 patients (33 eyes) were followed up for more than 3 years with 17 eyes in group A (MRSE -8.15 ± 1.41 D) and 16 eyes in group B (MRSE -12.95 ± 2.91 D). While postoperative refraction regression occurred in both groups, it was more prominent in group B (p<0.05). The long-term predictability is good in group A with 14 eyes (82.35%) within ±1 D of attempted correction at 3 years while the percentage in group B was 18.75%. The efficacy index was significantly different between the 2 groups (p<0.05): 0.84 ± 0.29 for group A and 0.61 ± 0.47 for group B at 3 years. The safety index was above 1.0 at each timepoint in both groups. Haze was at low level and faded with time after epi-LASIK. CONCLUSIONS: Epi-LASIK had a satisfactory long-term effect for high myopia of less than -10 D. Myopic regression limited the satisfaction of epi-LASIK in eyes with myopia of more than -10.0 D.

11Duration of topical steroid application after photorefractive keratectomy with mitomycin C.PubMed

Mojgan Pakbin, Mehdi Khabazkhoob, Mohammad Pakravan, et al.
J Cataract Refract Surg. 2020 Apr;46(4):622-632. doi: 10.1097/j.jcrs.0000000000000060.
Contradictory results of postoperative steroid application in photorefractive keratectomy (PRK) led to a meta-analysis of the existing data to achieve a definite conclusion on the optimum dosage and duration of corticosteroid therapy after PRK. The overall pooled unstandardized mean difference (PUMD) of the corneal haze score was -0.20 (95% CI, -0.29 to -0.12). In subgroup analysis, the PUMD of the corneal haze score was statistically significant in 2 subgroups, -0.57 (-0.85 to -0.30) for 3 to 6 months postoperatively and -0.13 (-0.23 to -0.04) for ≤ 3 months postoperatively. Analysis of the PUMD of postoperative spherical equivalent in participants with low to moderate myopia (≥-6.00 D) and high myopia (<-6.00 D) showed positive effects of steroids on prevention of myopia regression. In conclusion, long-term topical steroid application after PRK seems unnecessary in low and moderate myopia. New randomized clinical trials using current technologies are recommended for postoperative treatments.

12Long-term follow-up of Intacs for post-LASIK corneal ectasia.PubMed

George D Kymionis, Nikolaos S Tsiklis, Aristofanis I Pallikaris, et al.
Ophthalmology. 2006 Nov;113(11):1909-17. doi: 10.1016/j.ophtha.2006.05.043.
OBJECTIVE: To report long-term follow-up of Intacs microthin prescription inserts for the management of post-LASIK corneal ectasia. DESIGN: Long-term (5 years), retrospective, nonrandomized study. PARTICIPANTS: Eight eyes of 5 patients with post-LASIK corneal ectasia (3 men and 2 women) ages 31 to 54 years (mean age+/-standard deviation [SD], 41.60+/-9.24 years) who had completed 5 years of follow-up (mean follow-up +/- SD, 60.1+/-4.9 months; range, 57-68 months). INTERVENTION: Two Intacs segments, inserted in the usual fashion, were used for low myopia correction (1 each nasally and temporally), with thickness based on the residual refraction of the patients. MAIN OUTCOME MEASURES: Manifest refraction, uncorrected and best spectacle-corrected visual acuity, patient satisfaction, topography, and confocal microscopy analysis. RESULTS: No intraoperative or late postoperative complications occurred in this series of patients. At 5 years, the SE error was statistically significantly reduced (pre-Intacs mean+/-SD, -5.47+/-2.66 diopters [D]; range, -11.50 to -3.00 D) to -2.56+/-3.44 D (range, -9.50 to 1.5 D; P = 0.01). At the end of the first postoperative year, refractive stability was obtained and remained stable during the follow-up period with no significant changes between the interval meantime (P>0.05). Pre-Intacs uncorrected visual acuity was 20/100 or worse in all eyes (range, counting fingers-20/100), whereas at the last follow-up examination, 6 (75%) of 8 eyes had uncorrected visual acuity of 20/40 or better (range, counting fingers-20/25). Two eyes (25%) maintained the pre-Intacs best spectacle-corrected visual acuity, whereas the rest of the eyes (6 eyes; 75%) experienced a gain of 1 or 2 lines. At the end of the first postoperative year, uncorrected and best-spectacle corrected visual acuity and topographic stability were obtained and were shown to have remained stable during the follow-up period with no significant changes between the interval meantime. Lamellar channel deposits were observed in confocal microscopy at or adjacent to the intrastromal ring segment. CONCLUSIONS: Refractive stability was maintained for up to 5 years in the treatment of post-LASIK corneal ectasia after Intacs implantation. There was no evidence of progressive time-dependent corneal ectasia, late regression, or sight-threatening complications in this study.

13Prediction of long-term uncorrected distance visual acuity in surgically SMILE corrected myopic eyes using machine learning.PubMed

Xiaonan Yang, Lanqin Zhao, Qiting Feng, et al.
BMJ Open Ophthalmol. 2025 Sep 26;10(1):e001932. doi: 10.1136/bmjophth-2024-001932.
BACKGROUND: This study aimed to create machine learning (ML) models to predict the long-term uncorrected distance visual acuity (UDVA) in myopic eyes corrected by small incision lenticule extraction (SMILE). METHODS: This was a retrospective cohort study conducted in Zhongshan Ophthalmic Center, Sun Yat-sen University. Participants who underwent SMILE between 2012 and 2016 were invited for the final follow-up examinations in 2019. Medical records and surgical parameter data were collected for analysis. Multicollinearity analysis and feature importance ranking were used to select the most predictive features. The following algorithms were used: least absolute shrinkage and selection operator, random forest, extremely randomised regression trees (extraTrees), gradient boosting machine and extreme gradient boosting. The root mean square error (RMSE) and mean absolute error (MAE) for each ML model were evaluated. RESULTS: In total, 873 eyes from 440 patients with complete records were included in this study. The long-term UDVA (logarithm of the minimum angle of resolution) distribution at the final follow-up ranged from -0.1760 to 0.7960. The extraTrees model outperformed the other four models, with RMSE and MAE of 0.1162 and 0.0850, respectively. Additionally, some features, including spherical equivalent, lenticular optical zone, added manifest refraction, preoperative corrected distance visual acuity and cap thickness, had moderate-to-strong effects on the average UDVA prediction using the extraTrees model. CONCLUSION: Long-term UDVA in myopic eyes corrected by SMILE can be effectively predicted using ML technologies, particularly the extraTrees model. However, more features and samples for the prediction model need to be explored to improve accuracy. Otherwise, there was a limitation in this research that sphere and cylinder refraction were treated as independent variables. But, the proportion of astigmatism to spherical refraction is relatively low, less than 1/5. Consequently, this does not lead to the incorrectness of our results, but they are weakened by this.

14Post-Laser In Situ Keratomileusis Epithelial Ingrowth: Treatment, Recurrence, and Long-Term Results.PubMed

Nilufer Yesilirmak, Priyanka Chhadva, Florence Cabot, et al.
Cornea. 2018 Dec;37(12):1517-1521. doi: 10.1097/ICO.0000000000001760.
PURPOSE: To study outcomes after surgical removal of epithelial ingrowth (EI) in post-laser in situ keratomileusis patients, specifically comparing visual results and recurrence rates between 2 different EI management techniques. METHODS: In this retrospective chart review of 67 eyes of 54 patients who underwent surgical treatment for EI after laser in situ keratomileusis between July 1999 and July 2014 at the Bascom Palmer Eye Institute, Miami, FL, surgical techniques, recurrence rates, visual acuity (VA), and refractive error were assessed. RESULTS: Of the 67 eyes, 56 eyes (83.6%) had flap lift + scraping alone, and 11 eyes (16.4%) had flap lift + scraping + suturing. After mean follow-up of 2.5 years, 11 of 56 eyes (19.6%) treated with flap lift + scraping alone had EI recurrence, whereas no eyes treated with flap lift + scraping + suturing had EI recurrence. VA results and refractive errors were better in eyes treated with lift + scraping alone compared with lift + scraping + suturing at 1 month. In the 67 eyes with 1-year follow-up, VA and refractive errors improved from preoperative values and were comparable between groups. CONCLUSIONS: Scraping alone provides significantly better initial visual outcomes but higher EI recurrence rates compared with scrape-suturing. Long-term visual outcomes are comparable between 2 techniques.

15Short-term and long-term effects of small incision lenticule extraction (SMILE) on corneal endothelial cells.PubMed

Hui Zhang, Yan Wang, Shiyong Xie, et al.
Cont Lens Anterior Eye. 2015 Oct;38(5):334-8. doi: 10.1016/j.clae.2015.03.011. Epub 2015 Apr 25.
PURPOSE: Small incision lenticule extraction (SMILE) is being used increasingly as a novel approach to correct refractive errors with femtosecond laser. The study was aimed to investigate the corneal endothelial changes 1 day (short term) and 1 year (long term) after SMILE procedure. METHODS: In this prospective study, a total of 56 eyes of 30 patients with myopia ranging from -3.25 to -8.25 diopters (D) and cylinder up to -3.50D were treated by SMILE. Postoperative uncorrected distance visual acuity (UDVA) and complications were assessed. Endothelial cell density (ECD), the coefficient of variation (CV), and the percentage of hexagonal cells were measured using a noncontact specular microscope preoperatively and at 1 day and 1 year postoperatively. The estimated residual stromal thickness (RST) of each patient was recorded. RESULTS: The median UDVA improved significantly from 1.00logMAR preoperatively to -0.10logMAR both at 1 day and 1 year (p<0.001). No eyes developed corneal edema or other complications during the follow-up period. There were no significant changes in the ECD, CV or the percentage of hexagonal cells at any visit point (all p>0.05). The mean estimated RST was 355.1±32.2μm (range 290-429μm). Endothelial cell changes in terms of ECD, CV or the percentage of hexagonal cells were not correlated with the estimated RST (p>0.05). CONCLUSIONS: SMILE yielded improvement in visual acuity and no adverse effects to corneal endothelial cells were found. However, further studies with a lower preoperative ECD and deeper lenticule extraction are needed to conduct.

16Predictors of myopic photorefractive keratectomy retreatment.PubMed

Russell Pokroy, Michael Mimouni, Tzahi Sela, et al.
J Cataract Refract Surg. 2017 Jun;43(6):825-832. doi: 10.1016/j.jcrs.2017.06.001.
PURPOSE: To determine the factors associated with retreatment after photorefractive keratectomy (PRK) in myopic eyes. SETTING: Care-Vision Laser Centers, Tel-Aviv, Israel. DESIGN: Retrospective cohort study. METHODS: A large database on myopic PRK with mitomycin-C (MMC) performed from 2005 to 2012 was studied. Patients were divided into 2 groups according to whether they had retreatment. Multiple preoperative and intraoperative parameters were analyzed for association with retreatment. RESULTS: A total of 9699 eyes of 9699 consecutive patients were studied. The mean age was 25.9 years ± 7.3 (SD); 54.1% were men. The mean preoperative subjective spherical equivalent and astigmatism were -4.30 ± 2.18 diopters (D) (range -0.5 to -13.0 D) and 0.77 ± 0.83 D (range 0 to 6.0 D), respectively. Two hundred twenty-three eyes (2.30%) were retreated. The 2-year retreatment rate decreased from 42 (6.17%) for primary PRK treatments done in 2005 to 2 (0.10%) for primary PRK done in 2012 (R = 0.79, P < .001). Multiple binary logistic regression analysis showed that transepithelial PRK, astigmatism equal to or higher than 3.5 D, and surgeon factor significantly increased the odds of retreatment. Additional parameters significant on univariate analysis alone included age older than 40 years, low preoperative sphere, maximum ablation depth less than 45 μm, preoperative corrected distance visual acuity better than 20/20, MMC application longer than 40 seconds, and optical ablation zone smaller than 7.0 mm. CONCLUSION: The retreatment incidence of PRK has continued to decrease. High astigmatism and transepithelial PRK were associated with increased myopic PRK retreatment rates.

17Long-term results of thin corneas after refractive laser surgery.PubMed

George D Kymionis, Dimitrios Bouzoukis, Vasilios Diakonis, et al.
Am J Ophthalmol. 2007 Aug;144(2):181-185. doi: 10.1016/j.ajo.2007.04.010. Epub 2007 May 29.
PURPOSE: To report the long-term refractive results of photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK) in patients with thin corneas. DESIGN: A long-term, retrospective, non-randomized follow-up study. METHODS: Sixty-three patients (124 eyes) (28 males and 35 females), who had a preoperative central corneal thickness (CCT) of less than 500 microns and completed at least one year of follow-up examinations after surgery. Thirty-five patients (68 eyes) underwent PRK and 28 patients (56 eyes) underwent LASIK. RESULTS: Mean preoperative corneal pachymetry was 484.95 +/- 6.65 microm (range, 470 to 498 microm) and 482.38 +/- 10.73 microm (range, 453 to 499 microm) for LASIK and PRK, respectively. No intraoperative complications were found in both groups. None of the included eyes developed postrefractive corneal ectasia. The mean predictability for the PRK group was 0.08 diopters (D) with a standard deviation of 0.40 D (range, -1.38 to 1.00 D), and the mean predictability for the LASIK group was 0.14 D with a standard deviation of 0.55 D (range, -1.25 to 1.33 D). CONCLUSIONS: Refractive laser surgery with LASIK or PRK in patients with thin corneas (less than 500 microm) seems to be a safe and predictable technique for myopic refractive corrections.

18[Complications after laser in situ keratomileusis (LASIK): results of a meta-analysis on incidences and expectable costs].PubMed

J Lamparter, H B Dick, F Krummenauer
Klin Monbl Augenheilkd. 2007 Aug;224(8):627-35. doi: 10.1055/s-2007-963336.
PURPOSE: Laser in situ Keratomileusis (LASIK) is considered to be safe and effective for the treatment of moderate myopia. Nevertheless, the treatment can result in complications, associated with additional costs for treatment of the latter and an associated reduction of the primary treatment's overall cost efficiency. METHODS: To both identify clinically relevant LASIK-associated complications and to estimate their expectable incidence and treatment cost-profile, a quantitative meta-analysis of trial publications between 1995 - 2004 was implemented. Inclusion criteria were a minimum sample size of 25 eyes, a reported preoperative patient refraction between - 1 und - 14 dioptres and the documentation of an at least 6 months recall period. For each reported complication its "meta incidence" (point estimate and 95 % confidence interval) was estimated. Furthermore, for each complication a clinical pathway for its treatment was modelled assuming a worst case scenario; the treatment costs for this pathway were simulated. The resulting costs for the treatment of one complication were then averaged by the expectable incidence of the respective complication; the maximum "expectable" costs for the respective complication's treatment were then summed up to correct the overall LASIK direct costs. RESULTS: A total of 30 trial reports was included into the meta-analysis; in total, 21 clinically relevant complications were identified (31 % intraoperative complications, among which 19 % were microkeratome-associated, versus 69 % postoperative complications, among which 87 % were classified as long-term postoperative). The most frequent complication was "light sensations" with a meta incidence of 46 % (95 % confidence interval 42 - 50 %), the most cost intensive complications were those requiring clinical re-treatment (overall meta incidence 24 % and expectable cost increase of 449 euro per primary LASIK procedure). In summary the total direct costs of 2426 euro per eye for the initial LASIK procedure may be increased by a total of maximum 648.30 euro, according to a maximum "expectable" cost increase of 27 % per primary LASIK due to complications. CONCLUSION: At least the worst case scenario introduced into this investigation demonstrated an economically relevant order for the expectable LASIK complications and the associated additional costs for complication treatment.

1910-Year Results of Small Incision Lenticule Extraction.PubMed

Marcus Blum, Anna S Lauer, Kathleen S Kunert, et al.
J Refract Surg. 2019 Oct 1;35(10):618-623. doi: 10.3928/1081597X-20190826-02.
PURPOSE: To evaluate the 10-year results of refractive lenticule extraction using the small incision lenticule extraction (SMILE) technique for treatment of myopia and myopic astigmatism. METHODS: In 2008-2009, the first 91 eyes were treated using a novel surgical technique (SMILE), in which a refractive lenticule of intrastromal corneal tissue is removed through a small incision, completely eliminating flap cutting. A total of 56 of 91 eyes of the original treatment group volunteered for reexamination 10 years after surgery, including uncorrected and corrected distance visual acuity, objective and manifest refraction, and evaluation of the interface and corneal surface by slit-lamp examination. Late side effects such as corneal scarring, corneal ectasia, persistent dry eye symptoms, or cataract were documented. RESULTS: At 10 years postoperatively, there was no significant change from the 6-month results. Spherical equivalent was -0.35 ± 0.66 diopters and therefore close to target refraction. Sixteen of the 56 eyes (29%) had gained one to two Snellen lines. There was no loss of two or more lines in the long term. Regression was -0.35 ± 0.66 diopters over the 10-year period. CONCLUSIONS: This 10-year long-term study demonstrates SMILE to be an effective, stable, and safe procedure for the treatment of myopia and myopic astigmatism. [J Refract Surg. 2019;35(10):618-623.].

20Long-term results of laser in situ keratomileusis for high myopia: risk for ectasia.PubMed

Patrick I Condon, Michael O'Keefe, Perry S Binder
J Cataract Refract Surg. 2007 Apr;33(4):583-90. doi: 10.1016/j.jcrs.2006.12.015.
PURPOSE: To ascertain the long-term stability of laser in situ keratomileusis (LASIK) in highly myopic eyes. SETTING: Clinical practice office-based surgery. METHOD: Charts of eyes with high myopia who had LASIK surgery by the same surgeon between 1994 and 2000 were reviewed in 2003, and patients were given an appointment for follow-up examinations. In these highly myopic eyes, surgery was originally performed to create undercorrections with or without decreasing the ablation diameters to maximally conserve the residual stromal bed thickness. RESULTS: Of the 107 eyes with myopia between -10.00 diopters (D) and -35.00 D reviewed and operated on in a 3-year period between 1994 and 1998, 35 eyes of 31 patients had a single enhancement procedure. One case of ectasia as a result of excessive tissue removal occurred in a patient with a preoperative refraction of -28.00 D. Of the 107 eyes reviewed, 78 (73%) were examined after 5 years, 68 (63%) after 7 years, and 15 (14%) between 9 years and 11 years. CONCLUSIONS: Operating on eyes with highly myopic refractive errors and removing substantial tissue thickness did not produce ectasia in this series. Although high myopia has been considered a risk factor for post-LASIK ectasia, adherence to proper screening and intraoperative pachymetry appears to decrease the risk.
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