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已发表论文
一项关于三焦点人工晶状体在中国人群中开展的为期 12 个月的多中心上市后临床研究
Authors Liu X, Bao Y, Lu Y, Fan W, Bi H, Zhang H, Chen W, Liu J, Song X, Pang Y, Yao K
Received 21 May 2025
Accepted for publication 7 October 2025
Published 7 November 2025 Volume 2025:19 Pages 4117—4127
DOI https://doi.org/10.2147/OPTH.S541613
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Scott Fraser
Xin Liu,1 Yongzhen Bao,2 Yi Lu,3 Wei Fan,4 Hongsheng Bi,5 Hong Zhang,6 Weirong Chen,7 Jiewei Liu,8 Xudong Song,9 Yilin Pang,10 Ke Yao1
1Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People’s Republic of China; 2Department of Ophthalmology, Peking University People’s Hospital, Beijing, People’s Republic of China; 3Department of Ophthalmology, Eye & ENT Hospital of Fudan University, Shanghai, People’s Republic of China; 4Department of Ophthalmology, West China Hospital of Sichuan University, Chengdu, People’s Republic of China; 5Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine, Jinan, People’s Republic of China; 6Department of Cataract, Ophthalmology, Tianjin Medical University Eye Hospital, Tianjin, People’s Republic of China; 7State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangzhou, People’s Republic of China; 8Department of Cataract, Ophthalmology, Shanxi Eye Hospital, Taiyuan, People’s Republic of China; 9Eye Center, Beijing Tongren Hospital Capital Medical University, Beijing, People’s Republic of China; 10Clinical Development, Alcon (China) Ophthalmic Product Co., Ltd, Beijing, People’s Republic of China
Correspondence: Ke Yao, Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine, 1# Xihu Road, Shangcheng District, Hangzhou, Zhejiang Province, 310009, People’s Republic of China, Email xlren@zju.edu.cn
Purpose: This 12-month, prospective, single-arm, postmarketing study assessed efficacy, safety, and patient satisfaction for AcrySof IQ PanOptix TFNT00 intraocular lens in a Chinese population.
Patients and Methods: Adults with bilateral cataracts received TFNT00 (286 eyes); visual acuity (VA) was assessed at 12 months. Manifest refraction spherical equivalent (MRSE), corrected and uncorrected distance VA (CDVA, UDVA), distance-corrected and uncorrected intermediate (DCIVA, UIVA) and near (DCNVA, UNVA) VA, and defocus curve were evaluated. Patient-reported outcomes were assessed using questionnaires. Adverse events (AEs) were evaluated.
Results: 134/144 patients (268/286 eyes) completed the study. At 12 months, MRSE was − 0.06± 0.36 D. Monocular and binocular CDVA ≤ 0.3 logMAR was achieved in 99.3% of patients. Mean±SD monocular CDVA, UDVA, DCIVA, UIVA, DCNVA, and UNVA were − 0.01± 0.13, 0.04± 0.13, 0.076± 0.14, 0.089± 0.14, 0.084± 0.13, and 0.096± 0.13 logMAR, respectively. Binocular VA was equal to or better than 0.1 logMAR for defocus range +0.5 to − 3.0 D. Most patients achieved spectacle independence for distance (94%), intermediate (90%), and near (87%) vision; 88% were “satisfied” or “very satisfied.” No device-related AEs were reported. Forty eyes (14%) had posterior capsular opacity (37 were clinically nonsignificant; 1 [0.4%] required posterior capsulotomy). Five cystoid macular edema cases (1.7%) were reported. Severe starbursts, halo, and glare were reported by 15.6%, 4.4%, and 2.3% of patients, respectively, with only 1.5% of patients significantly bothered by each.
Conclusion: TFNT00 was safe and effective in a Chinese population, providing good VA at far, intermediate, and near distances, with high rates of spectacle independence and patient satisfaction.
Keywords: cataract surgery, intermediate visual acuity, PanOptix TFNT00, presbyopia
1Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People’s Republic of China; 2Department of Ophthalmology, Peking University People’s Hospital, Beijing, People’s Republic of China; 3Department of Ophthalmology, Eye & ENT Hospital of Fudan University, Shanghai, People’s Republic of China; 4Department of Ophthalmology, West China Hospital of Sichuan University, Chengdu, People’s Republic of China; 5Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine, Jinan, People’s Republic of China; 6Department of Cataract, Ophthalmology, Tianjin Medical University Eye Hospital, Tianjin, People’s Republic of China; 7State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangzhou, People’s Republic of China; 8Department of Cataract, Ophthalmology, Shanxi Eye Hospital, Taiyuan, People’s Republic of China; 9Eye Center, Beijing Tongren Hospital Capital Medical University, Beijing, People’s Republic of China; 10Clinical Development, Alcon (China) Ophthalmic Product Co., Ltd, Beijing, People’s Republic of China
Correspondence: Ke Yao, Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine, 1# Xihu Road, Shangcheng District, Hangzhou, Zhejiang Province, 310009, People’s Republic of China, Email xlren@zju.edu.cn
Purpose: This 12-month, prospective, single-arm, postmarketing study assessed efficacy, safety, and patient satisfaction for AcrySof IQ PanOptix TFNT00 intraocular lens in a Chinese population.
Patients and Methods: Adults with bilateral cataracts received TFNT00 (286 eyes); visual acuity (VA) was assessed at 12 months. Manifest refraction spherical equivalent (MRSE), corrected and uncorrected distance VA (CDVA, UDVA), distance-corrected and uncorrected intermediate (DCIVA, UIVA) and near (DCNVA, UNVA) VA, and defocus curve were evaluated. Patient-reported outcomes were assessed using questionnaires. Adverse events (AEs) were evaluated.
Results: 134/144 patients (268/286 eyes) completed the study. At 12 months, MRSE was − 0.06± 0.36 D. Monocular and binocular CDVA ≤ 0.3 logMAR was achieved in 99.3% of patients. Mean±SD monocular CDVA, UDVA, DCIVA, UIVA, DCNVA, and UNVA were − 0.01± 0.13, 0.04± 0.13, 0.076± 0.14, 0.089± 0.14, 0.084± 0.13, and 0.096± 0.13 logMAR, respectively. Binocular VA was equal to or better than 0.1 logMAR for defocus range +0.5 to − 3.0 D. Most patients achieved spectacle independence for distance (94%), intermediate (90%), and near (87%) vision; 88% were “satisfied” or “very satisfied.” No device-related AEs were reported. Forty eyes (14%) had posterior capsular opacity (37 were clinically nonsignificant; 1 [0.4%] required posterior capsulotomy). Five cystoid macular edema cases (1.7%) were reported. Severe starbursts, halo, and glare were reported by 15.6%, 4.4%, and 2.3% of patients, respectively, with only 1.5% of patients significantly bothered by each.
Conclusion: TFNT00 was safe and effective in a Chinese population, providing good VA at far, intermediate, and near distances, with high rates of spectacle independence and patient satisfaction.
Keywords: cataract surgery, intermediate visual acuity, PanOptix TFNT00, presbyopia