Abstract
Aim. To evaluate the results of implantation of a new hydrophobic acrylic monofocal IOL in an automated preloaded delivery system in the short-term follow-up period.Patients and methods. The prospective study included 89 patients (114 eyes) after bilateral or monolateral Clareon IOL implantation with a mean follow-up of 2.1 ± 0.4 (1–4) months. The age range was 53 to 87 (71.1 ± 5.2) years. A corneal incision of 1.8 mm was used in all cases. For implantation using the AutonoMe® system , the incision was enlarged by 0.2 mm for implantation IOL 26 D and higher. IOL optical power was calculated using the SRK/T formula; retrospective analysis was performed using the Hoffer Q, Haigis, Holladay II, Olsen, Barrett Universal II, and Kane formulas.Results. In all studied periods (1 day, 1 week and 1 month) there was statistically significant (p < 0.05) increase both of NCDVA (from 0.13 ± 0.02 in the preoperative period to 0.81 ± 0.07 in 1 month after surgical intervention), and BCDVA (from 0.32 ± 0.15 before surgery to 0.94 ± 0.11 after surgery). When assessing the percentage of eyes with an BCDVA of 0.9 or higher, a statistically significant (p < 0.05) difference was shown in all studied periods. The lowest MAE was shown for the Barrett Universal II (0.292), SRK/T (0.312) Kane (0.301), and Olsen (0.325) formulas. For the Hoffer Q and Holladay 2 formulas, MAE values were significantly higher (p < 0.05). The highest frequency of achieving the target refraction of ± 0.25 D was shown for the Barrett Universal II and Kane formulas (68 and 69 %, respectively), and the lowest for the Hoffer Q and Holladay 2 formulas (28 and 35 %, respectively). The primary endpoint of the study (BCDVA = 1.0) was achieved in 95.6 % (n = 109), with a deviation in BCVA of ± 0.1 noted in 4 eyes (3.5 %). No glistening was detected in the follow-up period up to 4 months.Conclusion. The paper presents an analysis of the first experience with the implantation of new Clareon monofocal IOLs in Russian Federation. The results of implantation of a new hydrophobic acrylic monofocal IOL in an automated preloaded delivery system showed a good clinical and functional effect, a high frequency of achieving the target result and the absence of significant side effects. The Kane, Barrett Universal II, and SRK/T formulas, using the Verion diagnostic navigation system, are recommended for calculating the optical power of the new IOL.
Highlights
При анализе характера помутнения ИОЛ из гидро‐ фобного акрила обращает на себя внимание наличие единичных или множественных вакуолей с эффек‐ том сверкания, так называемый глистенинг
A corneal incision of 1.8 mm was used in all cases
the incision was enlarged by 0.2 mm for implantation IOL 26 D
Summary
В проспективное исследование включены 89 пациен‐ тов (114 глаз) после билатеральной или монолатераль‐ ной имплантации ИОЛ Clareon (Alcon, США) со средним сроком наблюдения 2,1 ± 0,4 (1–4) месяца. Критерии включения пациентов в исследование: роговичный астигматизм менее 1,5 дптр, отсутствие предшествующих офтальмохирургических операций. Для имплантации с использованием системы AutonoMe® ИОЛ диоптрийностью 26 и выше разрез рас‐ ширяли на 0,2 мм. Расчет оптической силы ИОЛ прово‐ дили с применением формулы SRK/T, ретроспективный анализ — с помощью формул Hoffer Q, Haigis, Holladay II, Olsen, Barrett Universal II и Kane. Для каждой формулы определяли среднюю погрешность (ME), среднюю абсо‐ лютную погрешность (MAE), стандартное отклонение (SD), медианную абсолютную погрешность (MedAE), максимальную абсолютную погрешность (MaxAE), а также процент глаз в диапазоне погрешностей 0,25, 0,5, 1,0 и 2,0 дптр.
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