Evaluation and Refractive Results Comparison of MIOL-­SOFT-­2­-13 IOL Implantation with Foreign Models

Purpose. Evaluation and refractive results comparison of MIOL-­SOFT-­2­-13 (Reper­NN, Russia) IOL implantation with foreign models.

Material and methods. The study included 816 patients (816 eyes) who underwent phacoemulsification (PE) with IOL implantation, divided into four groups depending on IOL model: MIOL­-SOFT-2-­13 (Reper­-NN, Russia) (n = 199); SA60AT (Alcon, USA) (n = 237); Adapt AO (Bausch&Lomb, USA) (n = 179); Acryfold 601 (Appasamy Associates, India) (n = 201). All patients underwent optical biometry using IOL­-Master 500 (Carl Zeiss, Germany). A month after PE spherical equivalent of refraction was assessed by Topcon­8800 (Japan). Mean calculation error (ME) and mean absolute error (MAE) were used as a IOL calculation accuracy criterion.

Results. Zeroing of ME allowed to determine real a­constant of MIOL-­SOFT­-2-­13 (119.83 instead of 118.4 declared by the manufacturer). MAE in the groups was: 0.39 ± 0.27, 0.33 ± 0.35, 0.38 ± 0.31 and 0.38 ± 0.30 D, respectively (p = 0.068). All IOLs demonstrated hitting the target refraction within ±1.00 D in more than 95 % of cases.

Conclusion. MIOL­-SOFT­-2­-13 has comparable refractive results with other monofocal IOLs used in national medical insurance system. MIOL­-SOFT-­2­-13 achieves target refraction within ±1.00 D in 98 % of cases.

To obtain optimal refractive results, an optimized a­constant of 118.83 is required.

1. Federal clinical guidelines for the provision of ophthalmological care to patients with age‑related cataracts. Expert Council on the problem of surgical treatment of cataracts. Interregional Association of Ophthalmologists LLC. Moscow: Ophthalmology; 2015.Р. 3–26 (In Russ.).

2. Malichenko VS, Gadzhieva AO. Access to health technologies under sanctions and unilateral restrictive measures. International Law and International Organizations. 2023;3:27–41 (In Russ.). doi: 10.7256/2454‑0633.2023.3.43606.

3. Melles RB, Holladay JT, Chang WJ. Accuracy of Intraocular Lens Calculation Formulas. Ophthalmology. 2018 Feb;125(2):169–178. doi: 10.1016/j.ophtha.2017.08.027.

4. Hoffer KJ, Savini G. Update on Intraocular Lens Power Calculation Study Protocols: The Better Way to Design and Report Clinical Trials. Ophthalmology. 2021 Nov;128(11):e115–e120. doi: 10.1016/j.ophtha.2020.07.005.

5. Belov DF, Potemkin VV, Nikolaenko VP. Optimization of intraocular lens power calculation in pseudoexfoliation syndrome. The Russian Annals of Ophthalmology 2021;137(4):38–42 (In Russ.). doi: 10.17116/oftalma202113704138.

6. Abulafia A, Barrett GD, Koch DD, Wang L, Assia EI. Protocols for Studies of Intraocular Lens Formula Accuracy. Am J Ophthalmol. 2016 Apr;164:149–150. doi: 10.1016/j.ajo.2016.01.010.

7. Steinbeis GmbH & Co. KG für Technologietransfer, Willi‑Bleicher‑Str. 19, 70174 Stuttgart, Germany. URL: https://www.iolcon.org/index.php (Accessed: 06.02.2024).

8. Or L, Jacques A, Barrett GD. Autorefraction as an Objective Method to Evaluate Accuracy of Intraocular Lens Calculation Formulas. J Refract Surg. 2022 Sep;38(9):580– 586. doi: 10.3928/1081597X‑20220715‑01.

9. Retzlaff JA, Sanders DR, Kraff MC. Development of the SRK/T intraocular lens implant power calculation formula. J Cataract Refract Surg. 1990 May;16(3):333–340. doi: 10.1016/s0886‑3350(13)80705‑5.

10. Russian ophthalmology online. URL: https://eyepress.ru/products/rpr‑2‑rpr‑2‑ (Accessed: 11.02.2024).

11. Russian ophthalmology online. URL: https://eyepress.ru/products/acrysof‑singlepiece‑sa60at‑ (Accessed: 11.02.2024).

12. URL: https://www.eyecalcs.com/WEBCALCS/IOLcalc/IOL.html (Accessed: 11.02.2024).

13. URL: https://calc.apacrs.org/barrett_universal2105/ (Accessed: 11.02.2024).