Ramamurthy Dandapani, Vasavada Abhay, Padmanabhan Prema, Reddy Jagadesh C, Shetty Naren, Dey Arindam, Sudhir Rachapalle Reddi
The Eye Foundation, Coimbatore, Tamil Nadu, India.
Raghudeep Eye Hospital, Ahmedabad, Gujarat, India.
Clin Ophthalmol. 2021 Jan 22;15:213-225. doi: 10.2147/OPTH.S279001. eCollection 2021.
To evaluate the effectiveness and safety of a presbyopia-correcting trifocal intraocular lens (IOL), AcrySof IQ PanOptix (TFNT00), in an Indian population.
This prospective, multicenter, observational, single-arm, post-marketing study included 67 patients undergoing cataract surgery with bilateral implantation of TFNT00 across five Indian sites. Postoperative outcomes were assessed at 3 months after second eye surgery. Effectiveness outcomes included: mean binocular and monocular visual acuity (VA) at distance (4 m), intermediate (60 cm), and near (40 cm); binocular defocus curve; manifest refraction; and subjective symptom questionnaire evaluation. Safety outcomes included the rate of ocular adverse events and mesopic contrast sensitivity.
Mean binocular and monocular distance-corrected and uncorrected VAs of 0.1 logMAR or better (approximately 20/25 Snellen) were achieved at distance, intermediate, and near. Overall, ≥70% of patients achieved binocular 0.1 logMAR vision or better across all distances. TFNT00 maintained a mean VA of 0.1 logMAR or better at the defocus range of +0.5 diopters (D) to -2.5 D (200 cm to 40 cm). The subjective symptom questionnaire-assessed frequency of halo visual disturbances was low at Month 3; halos were reported "none of the time" to "only some of the time" in 86.6% of patients. The large majority of patients (98.5%) were "satisfied" or "very satisfied" with their near, intermediate, and distance vision at Month 3, and ≥94.0% of patients reported spectacle independence for tasks at all distances. The adverse event rate was low; no patients discontinued due to an adverse event.
TFNT00 provided a continuous range of vision of 20/25 or better for distance to near and performed effectively at an intermediate functional distance of 60 cm, resulting in high levels of spectacle independence and patient satisfaction. TFNT00 demonstrated a good safety profile and a low post-operative frequency of halo visual disturbances.
评估一款用于矫正老花眼的三焦点人工晶状体（IOL），即AcrySof IQ PanOptix（TFNT00），在印度人群中的有效性和安全性。
这项前瞻性、多中心、观察性、单臂上市后研究纳入了67例在印度五个地点接受白内障手术并双侧植入TFNT00的患者。在第二只眼手术后3个月评估术后结果。有效性结果包括：远距（4米）、中距（60厘米）和近距（40厘米）的双眼和单眼平均视力（VA）；双眼散焦曲线；显验光；以及主观症状问卷评估。安全性结果包括眼部不良事件发生率和中视觉对比敏感度。
在远距、中距和近距，双眼和单眼的平均远距矫正和未矫正视力达到0.1 logMAR或更好（约20/25 Snellen）。总体而言，≥70%的患者在所有距离上双眼视力达到0.1 logMAR或更好。TFNT00在+0.5屈光度（D）至-2.5 D（200厘米至40厘米）的散焦范围内保持平均视力0.1 logMAR或更好。主观症状问卷评估显示，第3个月时光晕视觉干扰的发生频率较低；86.6%的患者报告光晕“从未出现”至“仅偶尔出现”。绝大多数患者（98.5%）在第3个月时对其近距、中距和远距视力“满意”或“非常满意”，≥94.0%的患者报告在所有距离的任务中无需佩戴眼镜。不良事件发生率较低；没有患者因不良事件而停药。
TFNT00提供了从远距到近距连续的20/25或更好的视力范围，并且在60厘米的中功能距离上有效发挥作用，从而实现了高水平的无需佩戴眼镜状态和患者满意度。TFNT00显示出良好的安全性和较低的术后光晕视觉干扰发生率。
