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临床试验/NCT05220007
NCT05220007已完成不适用

Effect of Presbyopic Correction Lens on Humphrey Visual Field Testing in Patients With Multifocal Intraocular Lens

Siriraj Hospital2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
2
主要终点
Pattern standard deviation

研究概览

简要总结

Purpose of this study was to evaluate the effect of presbyopic correction lens on Humphrey visual field (HVF) testing in patients with 2 models of multifocal intraocular lens (MIOL) both with and without glaucoma. All participants performed HVF testing with presbyopic collection lenses and without presbyopic collection lenses on the same occasion (5-10 minutes between the test). The mean deviation (MD) and pattern standard deviation (PSD) were compared between with and without presbyopic collection lenses, between glaucoma and non-glaucoma and between 2 models of MIOL.

详细描述

This was a prospective comparative study in patients who underwent uneventful phacoemulsification with MIOL implantation at the Department of Ophthalmology, Faculty of Medicine, Siriraj Hospital, Mahidol University between June 2009 to July 2012. The study protocol was approved by the Siriraj Institutional Review Board complied with all of the principles set forth in the Declaration of Helsinki (1964) and its subsequent amendments. (certificate of approval number Si 003/2010). The written informed consent was obtained from each participant prior to participation. Each patient received a comprehensive eye examination with slit-lamp biomicroscopy, distant and near visual acuity, and auto-refraction. The eligible participants performed HVF 24-2 or 30-2 on the enrollment day with and without presbyopic correction lens. The participants were randomized to perform HVF with presbyopic collection lenses followed by without presbyopic collection lenses or without presbyopic collection lenses followed by with presbyopic collection lenses by simple randomization. Data collection included demographic data, distant (logMar) and near (Jaeger reading chart) BCVA, and HVF test result including mean deviation (MD), pattern standard deviation (PSD), test duration (minute), fixation loss, false positive, and false negative.

Multifocal intraocular lens characteristics There were two types of aspheric diffractive MIOL included in the study: TECNIS ZM900 (Abbott Medical Optics Inc, Santa Ana, CA, USA) and AcrySof IQ ReSTOR SN6AD1 (Alcon Laboratories, Inc., Irvine, CA, USA). The TECNIS ZM900 is a silicone 3-piece aspheric diffractive lens. The power of the add is +4.00 D with a 50/50 distance/near light distribution. The AcrySof IQ ReSTOR SN6AD1is an acrylic single-piece aspheric diffractive lens. The power of the add is +3.00 D with a 65/35 light distribution.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Glaucomatous and non-glaucomatous patients
  • Age older than 18 years
  • A history of uneventful phacoemulsification with MIOL implantation at least one month before participation
  • Distant best-corrected visual acuity (BCVA) equal to or better than 20/30
  • Near BCVA of at least Jaeger 2

排除标准

  • The inability to perform reliable visual field testing (fixation loss, false positive or false negative more than 25%)
  • A history of postoperative complications
  • Moderate to advanced visual field defects (MD less than - 6 dB)
  • Any other concurrent ocular diseases, except well-controlled glaucoma.

结局指标

主要结局

Pattern standard deviation

时间窗: at 1 day after enrollment

Pattern standard deviation from Humphrey visual field testing

Mean deviation

时间窗: at 1 day after enrollment

Mean deviation from Humphrey visual field testing

次要结局

  • False negative (percent)(at 1 day after enrollment)
  • False positive (percent)(at 1 day after enrollment)
  • Fixation loss (percent)(at 1 day after enrollment)
  • Test duration (minutes0(at 1 day after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naris Kitnarong

Associate professor

Siriraj Hospital

研究点 (2)

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