Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL

老花眼 验光服务 医学 眼科
作者
Chandra Bala,Francisco Poyales,M. Guarro,Ramón Ruíz-Mesa,Ali Mearza,Devesh Varma,Srichand Jasti,Jessie Lemp-Hull
出处
期刊:Journal of Cataract and Refractive Surgery [Lippincott Williams & Wilkins]
卷期号:48 (2): 136-143 被引量:48
标识
DOI:10.1097/j.jcrs.0000000000000712
摘要

Purpose: To evaluate the effectiveness and safety of a new presbyopia-correcting intraocular lens (IOL) with a nondiffractive design, DFT015, compared with an aspheric monofocal IOL, SN60WF. Setting: 19 investigational sites in 4 countries: Australia, Canada, Spain, and the United Kingdom. Design: Prospective, randomized, parallel-group, controlled, assessor- and patient-masked clinical study. Methods: Participants aged ≥22 years with bilateral cataracts were randomized to DFT015 or SN60WF in a 5:4 ratio and masked until final postoperative follow-up at month 6. The primary effectiveness objective was superiority of DFT015 over SN60WF in mean monocular photopic distance-corrected intermediate visual acuity (DCIVA) at month 3. Secondary effectiveness objectives included noninferiority of DFT015 to SN60WF in mean monocular photopic corrected distance visual acuity (CDVA) and superiority in the mean monocular photopic distance-corrected near visual acuity (DCNVA) at month 3. Visual disturbances were assessed at month 6. Results: 282 patients were randomized to DFT015 (n = 159) or SN60WF (n = 123). All effectiveness objectives were achieved at month 3 in first eyes. For monocular photopic results in first eyes, DFT015 demonstrated superior mean DCIVA (least squares means of −0.139 logMAR in favor of DFT015, P < .001), noninferior mean CDVA (97.5% upper confidence limit [UCL] of the difference was <0.1 logMAR) and superior mean DCNVA (95% UCL of the difference was <0.0 logMAR) compared with SN60WF at month 6. DFT015 exhibited a similar visual disturbance profile to that of SN60WF. Conclusions: DFT015 provided superior intermediate and near vision and a similar visual disturbance profile compared with an aspheric monofocal IOL.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
ding完成签到,获得积分10
1秒前
胡志飞发布了新的文献求助10
1秒前
科研通AI2S应助嗷嗷采纳,获得10
1秒前
zzz发布了新的文献求助10
2秒前
深情安青应助好宝宝采纳,获得10
2秒前
2秒前
2秒前
2秒前
3秒前
Noah完成签到 ,获得积分10
3秒前
SciGPT应助大冰采纳,获得10
3秒前
量子星尘发布了新的文献求助80
3秒前
天边发布了新的文献求助10
4秒前
未央歌完成签到 ,获得积分10
4秒前
4秒前
Xinger完成签到,获得积分10
5秒前
6秒前
sssaw发布了新的文献求助10
6秒前
RoKing发布了新的文献求助10
7秒前
香蕉觅云应助zy采纳,获得10
7秒前
Xinger发布了新的文献求助10
8秒前
xiaozhiok发布了新的文献求助10
8秒前
思垢发布了新的文献求助10
8秒前
9秒前
zjh完成签到,获得积分10
10秒前
11秒前
好想走到伯纳乌完成签到,获得积分10
11秒前
Rondab应助mariawang采纳,获得10
11秒前
田様应助ly楠采纳,获得10
11秒前
李爱国应助天边采纳,获得10
12秒前
大模型应助RoKing采纳,获得10
13秒前
kd发布了新的文献求助10
13秒前
胡志飞完成签到,获得积分20
13秒前
xiaozhiok完成签到,获得积分10
13秒前
14秒前
14秒前
淡淡夕阳发布了新的文献求助10
15秒前
16秒前
17秒前
爆米花应助voifhpg采纳,获得10
17秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3988732
求助须知:如何正确求助?哪些是违规求助? 3531027
关于积分的说明 11252281
捐赠科研通 3269732
什么是DOI,文献DOI怎么找? 1804764
邀请新用户注册赠送积分活动 881869
科研通“疑难数据库(出版商)”最低求助积分说明 809021