Rotational stability and refractive outcomes of a new hydrophobic acrylic toric intraocular lens.

IF 4.1 1区 医学 Q1 OPHTHALMOLOGY
Daniel Schartmüller, Marcus Lisy, Nikolaus Mahnert, Markus Schranz, Victor Danzinger, Luca Schwarzenbacher, Stefan Pieh, Claudette Abela-Formanek, Christina Leydolt, Rupert Menapace
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Abstract

Purpose: To assess rotational stability and refractive outcomes of a new toric hydrophobic acrylic intraocular lens (IOL).

Design: Single-center, prospective, interventional clinical trial.

Methods: A total of 130 eyes of 82 patients with age-related cataract and total corneal astigmatism of greater than 1.0 diopters (D) received a hydrophobic acrylic toric IOL Clareon CNW0T3-9. Baseline measurement for rotational stability evaluation was performed at the end of surgery (EOS), with the patient still supine on the operating table, using non-movable vessels as reference landmarks. Postoperative retroillumination pictures were taken at 1 h, 1 week, 1 month and 4-6 months postoperatively. Subjective manifest refraction was assessed at the 6 months follow-up visit.

Results: Final results were obtained in 126 eyes of 80 patients. Mean absolute rotation from EOS to 6 months was 1.33 ± 2.00 [0.01, 19.80] degrees. Rotational stability values from EOS to 1 h, 1 h to 1 week, 1 week to 1 month and 1 month to 6 months were 0.86 ± 0.82 [0.00, 3.90], 1.06 ± 1.94 [0.00, 19.45], 0.47 ± 0.42 [0.00, 2.03] and 0.38 ± 0.40 [0.00, 2.56] degrees. Mean preoperative corneal astigmatism was 1.78 ± 0.83 [1.00, 4.76] D which changed to a mean postoperative refractive astigmatism of 0.33 ± 0.27 [0.00, 1.25] D at 6 months.

Conclusion: The Clareon toric IOL presented very good rotational stability with a mean absolute rotation below 1.4° from EOS to 6 months. Only two IOLs rotated more than 5° with none of them requiring repositioning surgery. Refractive outcomes were satisfying with a mean residual refractive astigmatism below 0.50 D.

Trial registration: Registered at Clinicaltrials.gov NCT03803852 ; on May 17, 2022.

新型疏水性丙烯酸散光眼内透镜的旋转稳定性和屈光效果。
目的:评估新型散光疏水丙烯酸眼内透镜(IOL)的旋转稳定性和屈光效果:单中心、前瞻性、介入性临床试验:82名患有老年性白内障且角膜散光大于1.0屈光度(D)的患者共130只眼睛接受了疏水性丙烯酸散光人工晶体Clareon CNW0T3-9。旋转稳定性评估的基线测量是在手术结束(EOS)时进行的,当时患者仍仰卧在手术台上,使用不可移动的血管作为参考地标。分别在术后 1 小时、1 周、1 个月和 4-6 个月拍摄术后反照照片。术后 6 个月随访时评估主观屈光度:80名患者的126只眼睛获得了最终结果。从EOS到6个月的平均绝对旋转度为1.33 ± 2.00 [0.01, 19.80]度。从EOS到1小时、1小时到1周、1周到1个月和1个月到6个月的旋转稳定值分别为0.86 ± 0.82 [0.00, 3.90]、1.06 ± 1.94 [0.00, 19.45]、0.47 ± 0.42 [0.00, 2.03]和0.38 ± 0.40 [0.00, 2.56]度。术前平均角膜散光度数为 1.78 ± 0.83 [1.00, 4.76] D,术后 6 个月平均屈光散光度数为 0.33 ± 0.27 [0.00, 1.25] D:Clareon散光人工晶体的旋转稳定性非常好,从EOS到6个月的平均绝对旋转角度低于1.4°。只有两个人工晶体旋转超过 5°,没有一个需要重新定位手术。屈光结果令人满意,平均残余屈光散光低于 0.50 D:试验注册:于 2022 年 5 月 17 日在 Clinicaltrials.gov NCT03803852 注册。
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来源期刊
Eye and Vision
Eye and Vision OPHTHALMOLOGY-
CiteScore
8.60
自引率
2.40%
发文量
89
审稿时长
15 weeks
期刊介绍: Eye and Vision is an open access, peer-reviewed journal for ophthalmologists and visual science specialists. It welcomes research articles, reviews, methodologies, commentaries, case reports, perspectives and short reports encompassing all aspects of eye and vision. Topics of interest include but are not limited to: current developments of theoretical, experimental and clinical investigations in ophthalmology, optometry and vision science which focus on novel and high-impact findings on central issues pertaining to biology, pathophysiology and etiology of eye diseases as well as advances in diagnostic techniques, surgical treatment, instrument updates, the latest drug findings, results of clinical trials and research findings. It aims to provide ophthalmologists and visual science specialists with the latest developments in theoretical, experimental and clinical investigations in eye and vision.
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