Russian Journal of Clinical Ophthalmology
ISSN 2311-7729 (Print), 2619-1571 (Online)

The efficacy of LASIK and secondary piggyback IOL implantation for the enhancement after cataract surgery

Open access Antiplagiat

E-library Dimensions
VAK russian citation index ULRICHS
road doaj
ebsco РГБ

Impact factor - 0,820*

* Impact factor according to the SCIENCE INDEX 2017



DOI: 10.32364/2311-7729-2020-20-3-122-127

The efficacy of LASIK and secondary piggyback IOL implantation for the enhancement after cataract surgery

E.P. Gurmizov1, K.B. Pershin2, N.F. Pashinova2, A.Yu. Tsygankov2

1LLC “Diagnostic Center “Vision”, St. Petersburg, Russian Federation

2LLC “SovMedTech”, Moscow, Russian Federation

Aim: to compare the efficacy of laser-assisted in situ keratomileusis (LASIK) and secondary piggyback intraocular lens (IOL) implantation for residual refractive errors after cataract surgery.

Patients and Methods: prospective open-label study included 74 patients (98 eyes) who underwent cataract surgery (53 eyes) or refractive lens exchange (45 eyes) with the implantation of various IOL models. Inclusion criterion was residual refractive error persisted for 6 months or more after IOL implantation that required additional surgery. Of 74 patients, 52.7% (n=37) were men and 47.3% (n=35) were women. Mean age was 51.7±11.2 years (19–86 years). Group I included 50 patients who underwent standard LASIK (72 eyes). Group II included 24 patients (26 eyes) who underwent secondary piggyback IOL implantation (Rayner Sulcoflex, 19 eyes, or Add-onTorica-sPB A4FW, 7 eyes).

Results: in group I, no significant changes in spherical equivalent were revealed postoperatively (0.38±1.37 and 0.33±0.55, respectively). Cylindrical equivalent reduced from -0.93±1.35 to -0.12±0.73 (p<0.05). Distance uncorrected visual acuity (UCVA) significantly improved after a maximum follow-up from 0.37±0.16 to 0.76±0.19 (p<0.05) while distance best-corrected visual acuity (BCVA) remained unchanged. In group II, distance UCVA significantly improved from 0.26±0.21 to 0.84±0.16 (p<0.05) while distance BCVA improved from 0.85±0.16 to 0.89±0.15 (p>0.05). Spherical and cylindrical equivalents reduced from -0.07±3.3 to 0.02±0.4 and from -1.17±2.4 to -0.55±0.91, respectively (p>0.05). No significant changes in keratometry readings were revealed (p>0.05). Safety index was 1.03 in group I and 1.06 in group II (p>0.05). Efficacy index was 0.92 in group I and 0.99 in group II (p>0.05).

Conclusion: our findings demonstrate that both LASIK and secondary piggyback IOL implantation are effective for residual refractive errors after cataract surgery. Significant improvement of distance UCVA was revealed in both groups. LASIK results in significant decrease of cylindrical equivalent. Efficacy and safety indices were similar in the groups. Secondary piggyback IOL implantation is recommended for residual high myopia and hyperopia while LASIK is recommended for residual low to moderate myopia and low hyperopia. Therefore, both enhancement techniques may be applied in ophthalmological practice.

Keywords: pseudophakia, LASIK, secondary piggyback IOLs, femtoLASIK, enhancement, residual refractive error.

For citation: Gurmizov E.P., Pershin K.B., Pashinova N.F., Tsygankov A.Yu. The efficacy of LASIK and secondary piggyback IOL implantation for the enhancement after cataract surgery. Russian Journal of Clinical Ophthalmology. 2020;20(3):122–127. DOI: 10.32364/2311-7729-2020-20-3-122-127.

Background

Despite significant progress in the development of novel intraocular lens (IOL) models and the latest generation IOL power calculation formulas, the correction of residual ametropia after cataract surgery or refractive lens exchange is still a challenge facing ophthalmic surgeons [1-3]. The rate of refractive surprises is low. However, residual ametropia precludes postoperative visual and social adaptation [4]. A mean prognostic error (PE) and mean absolute error (MAE) are among the most relevant factors [4]. It was demonstrated that IOL power calculation formula, IOL characteristics, age, gender, and laterality equally affect the likelihood of postoperative refractive error [5]. Meanwhile, studies that compare various refractive enhancement procedures in pseudophakic eyes are limited.

Aim

To compare the efficacy of laser-assisted in situ keratomileusis (LASIK) and secondary piggyback IOL implantation for residual refractive errors after cataract surgery.

Patients & Methods

74 patients (98 eyes) who underwent cataract surgery (53 eyes) or refractive lens exchange (45 eyes) with IOL implantation in 2012-2017 were enrolled. Inclusion criterion was a residual refractive error persisted for 6 months or more after IOL implantation that required an additional surgery. Of 74 patients, 52.7% (n = 37) were men and 47.3% (n = 35) were women. Mean age was 51.7 ± 11.2 years (19-86 years). Both standard (i.e., autorefractometry, tonometry, visual acuity measurement, computed perimetry, slit-lamp examination, dilated fundus examination) and specialized (i.e., corneal topography, ultrasonography, ultrasound pachymetry, optical coherence biometry for measuring axial length, anterior chamber depth, and corneal curvature, and, as needed, optical coherence tomography) eye examinations were performed in a total of 74 patients.

Treatment groups were arranged as follows. Group 1 included 50 patients who underwent standard LASIK (72 eyes). In 6 eyes (8.3%), femtosecond-assisted LASIK (WaveLight® FS200, Alcon, USA) was performed. Mean IOL power was 21.7 ± 3.4 D (13-30 D). Target refraction was ± 0.25 D in the majority of the patients (97.5%), -1.5 D, and -2.5 D. Mean follow-up period was 7.1 ± 1.2 months (6-12 months).

Group 2 included 24 patients (26 eyes) who underwent secondary piggyback IOL implantation. Either Rayner Sulcoflex (19 eyes, 73.1%) or Add-onTorica-sPB A4FW (7 eyes, 26.9%) was implanted as described earlier [6, 7]. Target refraction was ± 0.25 D. Mean follow-up period was 6.6 ± 1.0 months (6-10 months).

In group 1, dry age-related macular degeneration (AMD), high myopia, and staphyloma (n = 2, 2.8%), AMD (n = 12, 16.7%), early glaucoma (n = 1, 1.4%), amblyopia (n = 21, 29.2%), and Fuchs’ dystrophy (n = 2, 2.8%) were diagnosed preoperatively. In group 2, AMD (n = 3, 11.5%), early glaucoma (n = 2, 7.7%), non-progressive keratoconus (n = 3, 11.5%), amblyopia (n = 2, 7.7%), and post-LASIK for high myopia (n = 2, 7.7%) were diagnosed preoperatively.

Postoperatively, major biometric and refractive functional parameters were measured for each eye separately. In addition, indices of efficacy and safety were calculated. Efficacy index was calculated as a mean postoperative distance uncorrected visual acuity (UCVA) divided by a mean postoperative distance best-corrected visual acuity (BCVA). Safety index was calculated as a mean postoperative distance BCVA divided by a mean preoperative distance BCVA.

Main patient characteristics are listed in Table 1.

Таблица 1. Общая характеристика пациентов в доопера- ционном периоде Table 1. Preoperative clinical characteristics of patients

Statistical analysis was performed using Microsoft Excel 2010 (Microsoft Corp., USA) and Statistica v. 10.1 (StatSoft, USA) software. Arithmetic mean (M), standard deviation (SD), minimum and maximum values were calculated. Student’s t-test was used to assess the reliability of the results. Fisher’s exact test was used to compare the incidences of parameters. Confidence interval was 95%.

Results & Discussion

In group 1, no significant changes in spherical equivalent (SE) were revealed postoperatively (0.38 ± 1.37 D and 0.33 ± 0.55 D, respectively), maximum SE was ± 1.5 D (see Fig. 1). Cylindrical equivalent (CE) significantly (p < 0.05) reduced from -0.93 ± 1.35 D to -0.12 ± 0.73 D (see Fig. 2), in 3 eyes, CE was more than ± 1.5 D. Distance UCVA significantly improved after a maximum follow-up from 0.37 ± 0.16 to 0.76 ± 0.19 (p < 0.05) while distance BCVA remained unchanged. No significant changes in keratometry readings (К1: 42.2 ± 2.14 D; К2: 43.5 ± 6.12 D) were revealed postoperatively (p > 0.05).

Рис. 1. Диаграмма значений сферического компонента рефракции в до- и послеоперационном периоде в группе

Рис. 2. Диаграмма значений цилиндрического компо- нента рефракции в до- и послеоперационном периоде в группе I Fig. 2. Pre- and postoperative cylindrical equivalent in group I

In group 2, distance UCVA significantly improved from 0.26 ± 0.21 to 0.84 ± 0.16 (p < 0.05) while distance BCVA non-significantly improved from 0.85 ± 0.16 to 0.89 ± 0.15 (p > 0.05). SE and CE reduced from -0.07 ± 3.3 D to 0.02 ± 0.4 D and from -1.17 ± 2.4 D to -0.55 ± 0.91 D, respectively (p > 0.05). Maximum SE and CE were -1 D and -1.5 D, respectively (see Figs. 3 and 4). No significant differences in keratometry readings between the groups were revealed (K1: 40.7 ± 3.89 D and 40.6 ± 4.05 D, respectively; K2: 43.3 ± 4.79 D and 43.1 ± 4.96 D, respectively). In 4 eyes, the rotation of secondary piggyback IOL required reoperation.

Рис. 3. Диаграмма значений сферического компонента рефракции в до- и послеоперационном периоде в группе II Fig. 3. Pre- and postoperative spherical equivalent in group II

Рис. 4. Диаграмма значений цилиндрического компо- нента рефракции в до- и послеоперационном периоде в группе II Fig. 4. Pre- and postoperative cylindrical equivalent in group II

Safety index was 1.03 in group 1 and 1.06 in group 2 (p > 0.05). Efficacy index was 0.92 in group 1 and 0.99 in group 2 (p > 0.05). These results may be accounted for by a greater variation of preoperative distance UCVA and BCVA in group 2.

Additionally, both groups were divided into the subgroups based on the kind of ametropia, i.e., A (hyperopia or hyperopia and astigmatism) and B (myopia or myopia with astigmatism).

In subgroup 1A (49 eyes), distant UCVA significantly increased from 0.38 ± 0.16 to 0.75 ± 0.18 (p < 0.05) while distant BCVA changed non-significantly. Both SE and CE significantly reduced from 1.22 ± 0.41 D to 0.45 ± 0.08 D (p < 0.05) and from -0.98 ± 0.2 D to -0.09 ± 0.17 D (p < 0.05), respectively. Keratometry readings, i.e., K1 (from 41.4 ± 2.18 D to 41.8 ± 2.25 D) and K2 (from 43.4 ± 2.08 D to 43.3 ± 1.9 D), changed non-significantly (p > 0.05).

In subgroup 1B (24 eyes), distant UCVA significantly increased from 0.30 ± 0.15 to 0.78 ± 0.21 (p < 0.05) while distant BCVA changed non-significantly (from 0.84 ± 0.11 to 0.87 ± 0.12). SE significantly reduced from 0.96 ± 0.7 D to 0.05 ± 0.65 D (p < 0.05) while CE non-significantly reduced from -0.8 ± 0.53 D to -0.39 ± 0.42 D (p > 0.05). Keratometry readings, i.e., K1 (from 44.2 ± 1.6 D to 43.2 ± 1.7 D) and K2 (from 45.3 ± 1.4 D to 44.2 ± 1.5 D), changed non-significantly (p > 0.05).

In subgroup 2A (13 eyes), distant UCVA significantly increased from 0.34 ± 0.22 to 0.87 ± 0.13 (p < 0.05) while distant BCVA changed non-significantly. SE significantly reduced from 2.42 ± 1.74 D to -0.14 ± 0.5 D (p < 0.05) while CE non-significantly reduced from -0.17 ± 2.42 D to -0.15 ± 0.91 D (p > 0.05).

In subgroup 2B (12 eyes), distant UCVA significantly increased from 0.16 ± 0.15 to 0.80 ± 0.18 (p < 0.05) while distant BCVA non-significantly increased from 0.81 ± 0.15 to 0.91 ± 0.13 (p > 0.05). Both SE and CE significantly reduced from -2.95 ± 2.27 D to 0.16 ± 0.42 D (p < 0.05) and from -2.61 ± 1.55 D to -0.59 ± 0.96 (p < 0.05), respectively.

Comparative analysis in the subgroups (1A vs. 2A, 1B vs. 2B) has demonstrated that secondary piggyback IOL implantation provides more favorable outcomes in moderate to high residual hyperopia and high myopia. LASIK provides more favorable outcomes in low to moderate myopia and low hyperopia.

The choice of refractive enhancement technique after IOL implantation is still an important issue for ophthalmologists. A widespread introduction of innovative procedures, the development of novel refractive surgery options and secondary piggyback IOLs allow for the correction based on specific anatomical and functional patient characteristics.

We failed to find similar published articles on the comparative analysis of LASIK and secondary piggyback IOL implantation in matched patient groups. Numerous studies on the efficacy of major surgical options for ametropia in pseudophakic eyes (including corneal refractive procedures, IOL exchange, and secondary piggyback IOL implantation) are available [8-12]. Meanwhile, these papers largely address the analysis of authors’ data on the efficacy of either enhancement techniques alone. Only some studies compare two or more enhancement techniques. Thus, Н.Е. El Awady et al. report on the outcomes of residual ametropia correction in 23 patients by secondary piggyback IOL implantation in the ciliary sulcus or IOL exchange. The authors conclude that secondary piggyback IOL implantation is a safe, effective, and technically simple alternative to IOL exchange in patients with residual myopia or hyperopia following primary IOL implantation [13].

In Russia, a pioneer study was performed by M.M. Bikbov et al. in 2012. The authors analyzed optical aberrations in pseudophakic eyes after piggyback IOL (Sulcoflex) implantation and LASIK. The decrease of lower-order aberrations without the increase of total higher-order aberrations was reported in both groups [14]. Similar results were obtained by Yu.V. Takhtaev and E.G. Bogachuk. The authors analyzed induced ametropias and contrast sensitivity in pseudophakic eyes after LASIK, piggyback IOL implantation, and IOL exchange. Minimal contrast sensitivity was reported after piggyback IOL implantation [15]. We did not investigate these parameters.

M.I. Khan & М. Muhtaseb published the results of piggyback IOL (Sulcoflex) implantation in 4 patients. In 1 patient, bilateral LASIK and refractive lens exchange with accommodating IOL implantation was performed. In 3 patients, cataract surgery with monofocal IOL implantation was performed. In all patients, refractive improvement was reported [16].

Conclusions

Our findings demonstrate that both LASIK and secondary piggyback IOL implantation are effective for residual refractive errors in pseudophakic eyes. The significant improvement of distance UCVA was revealed in both groups. LASIK results in significant CE decrease. Efficacy and safety indices were similar in the groups. Secondary piggyback IOL implantation is recommended for residual high myopia and hyperopia while LASIK is recommended for residual low to moderate myopia and low hyperopia. Therefore, both enhancement techniques may be applied in ophthalmological practice.


About the authors:

1Evgeniy P. Gurmizov — MD, PhD, Head Doctor, ORCID iD 0000-0002-3438-3404;

2Kirill B. Pershin — MD, PhD, Professor, Medical Director, ORCID iD 0000-0003-3445-8899;

2Nadezhda F. Pashinova — MD, PhD, Head Doctor, ORCID iD 0000-0001-5973-0102;

2Aleksandr Yu. Tsygankov — MD, PhD, Scientific Advisor of Medical Director, ORCID iD 0000-0001-9475-3545.

1LLC “Diagnostic Center “Vision”. 6, Apraksin lane, St. Petersburg, 191023, Russian Federation.

2LLC “SovMedTech”. 3/1, Marksistskaya str., Moscow, 109147, Russian Federation.


Contact information: Aleksandr Yu. Tsygankov, e-mail: alextsygankov1986@yandex.ru. Financial Disclosure: no authors have a financial or property interest in any material or method mentioned. There is no conflict of interests. Received 05.11.2019. 

References
1. Garcia-Zalisnak D.E., Yeu E. Refractive Enhancements After Cataract Surgery. Int Ophthalmol Clin. 2016;56(3):85–91. DOI: 10.1097/IIO.0000000000000121.
2. Pershin K.B., Pashinova N.F., Tsygankov A. Yu. et al. Management of residual refractive error after cataract phacoemulsification. Part 1. Keratorefractive approaches. Ophthalmology in Russia. 2017;14(1):18–26 (in Russ.). DOI: 10.18008/1816-5095-2017-1-18-26.
3. Pershin K.B., Pashinova N.F., Tsygankov A.Yu. et al. Management of residual refractive error after cataract phacoemulsification.Part 2. Intraocular approaches. Ophthalmology in Russia. 2017;14(2):106–112 (in Russ.). DOI: 10.18008/1816-5095-2017-2-106-112.
4. Posvaliuk V.D. Clinical results of the secondary correction of ametropia in patients with pseudophakia. Tihookeanskij medicinskij žurnal. 2016;3(65):74–75 (in Russ.). DOI: 10.17238/PmJ1609-1175.2016.3.74-76.
5. Popov I., Valašková J., Krásnik V., Tomčíková D. Effect of multiple variables on the refractive error after cataract surgery. Cesk Slov Oftalmol. 2019;74(4):158–161. DOI: 10.31348/2018/1/4-6-2018.
6. Pershin K.B., Pashinova N.F., Gurmizov E.P., Tsygankov A.Yu. Results of implantation of additional pseudophakictoric sulcus intraocular lens for the correction of residual ametropia after phacoemulsification of cataract. Meditsinskiy al’manakh. 2018;2(53):68–71 (in Russ.). DOI: 10.21145/2499-9954-2018-2-68-70.
7. Pershin K.B., Pashinova N.F., Konovalov M.E. et al. Correction of high corneal astigmatism during cataract surgery. Ophthalmology in Russia. 2018;15(4):405–410 (in Russ.). DOI: 10.18008/1816-5095-2018-4-405-410.
8. Habot-Wilner Z., Sachs D., Cahane M. et al. Refractive results with secondary piggyback implantation to correct pseudophakic refractive errors. J Cataract Refract Surg. 2005;31(11):2101–2103. DOI: 10.1016/j.jcrs.2005.05.023.
9. Eissa S.A. Management of pseudophakic myopic anisometropic amblyopia with piggyback Visian implantable collamer lens. Acta Ophthalmol. 2017;95(2):188–193. DOI: 10.1111/aos.13203.
10. Ang R.E., Reyes R.M., Solis M.L. Reversal of a presbyopic LASIK treatment. Clin Ophthalmol. 2015;9:115–119. DOI: 10.2147/OPTH.S72676.
11. Gurmizov E.P., Pershin K.B., Pashinova N.F., Tsygankov A.Yu. The outcomes of residual ametropia correction by LASIK and PRK on pseudophakic eye depending in IOL model. Russian Journal of Clinical Ophthalmology. 2019;19(2):67–72 (in Russ.). DOI: 10.32364/2311-7729-2019-19-2-67-72.
12. Gundersen K.G., Potvin R. A review of results after implantation of a secondary intraocular lens to correct residual refractive error after cataract surgery. Clin Ophthalmol. 2017;11:1791–1796. DOI: 10.2147/OPTH.S144675.
13. El Awady H.E., Ghanem A.A. Secondary piggyback implantation versus IOL exchange for symptomatic pseudophakic residual ametropia. Graefes Arch Clin Exp Ophthalmol. 2013;251(7):1861–1866. DOI: 10.1007/s00417-013-2283-x.
14. Bikbov M.M., Bikbulatova A.A., Khusnitdinov I.I., Mannanova R.F. Comparison analysis of changes of pseudophakic eye optic system aberrations after add-on IOL Sulcoflex implantation and excimerlaser intrastromal keratomileusis. Vestnik Orenburgskogo gosudarstvennogo universiteta. 2012;12(148):19–22 (in Russ.).
15. Tahktaev Y.V., Bogachuk E.G. Current estimate of functional vision in patients with bifocal pseudophakia after correction of residual defocus by different methods. Oftal’mologicheskiye vedomosti. 2012;12(148):19–22 (in Russ.). DOI: 10.17816/OV9119-23.
16. Khan M.I., Muhtaseb M. Performance of the Sulcoflex piggyback intraocular lens in pseudophakic patients. J Refract Surg. 2011;27(9):693–696. DOI: 10.3928/1081597X-20110512-01.



License Creative Commons
This work is licensed under a Creative Commons «Attribution» 4.0 License.
Previous article
Next article

Register now and get access to useful services:
  • Загрузка полнотекстовых версий журналов (PDF)
  • Медицинские калькуляторы
  • Список избранных статей по Вашей специальности
  • Видеоконференции и многое другое

С нами уже 50 000 врачей из различных областей.
Присоединяйтесь!

Fatal error: Call to undefined function get_registration_form_description_popup() in /home/c/cb72209/clinopht.com/public_html/en/include/reg_form.php on line 89