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临床试验/NCT02264457
NCT02264457Unknown4 期

A Randomised Intra-patient Comparison of Closed Loop and Plate Haptic Toric, Aspheric, Aberration Neutral, Hydrophilic Acrylic Intraocular Lenses in Patients With Bilateral Astigmatism

University of Plymouth1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
30
试验地点
1
主要终点
Best-corrected visual acuity

研究概览

简要总结

During cataract surgery an artificial lens is implanted in the eye. These artificial lenses are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your eyes have astigmatism, which is a normal and common characteristic of the eye. If left uncorrected the astigmatism would mean that you would need to wear spectacles for viewing distance objects. New IOL designs called toric IOLs help to correct the astigmatism to improve your vision after cataract surgery. This study has been designed to look at how well a toric IOL corrects this astigmatism so that you do not need to wear spectacles for viewing distance objects. There are many designs of these toric IOLs and for this study we are looking to compare two different designs of toric IOLs by putting one lens in your right eye and a different type of lens in your left eye. Both lenses are commercially available and are commonly implanted IOLs. Using new non-invasive methods we hope to be able to better judge the visual performance of these lenses and the ability of these lenses to correct astigmatism. In addition the study will involve imaging and examining the IOLs to determine the prevalence of any post-operative complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • •Age 50-75 years, bilateral significant corneal astigmatism >1.50D.
  • •Requiring a Toric IOL within the following power range:
  • •Sphere +6.00D to +30.00D
  • •Cylinder +1.00D to +6.00D

排除标准

  • •Amblyopia,
  • •predicted bilateral post-op corneal astigmatism of <1.50D,
  • •irregular astigmatism,
  • •dilated pupil size smaller than 5mm,
  • •macular pathology,
  • •glaucoma,
  • •retinal disease,
  • •corneal disease,
  • •abnormal iris,
  • •pupil deformation and
  • •any previous corneal or intraocular surgery.

研究组 & 干预措施

First eye plate haptic

Other

subjects implanted with the plate haptic toric during first eye surgery and the closed loop haptic toric intraocular lens during second eye surgery

干预措施: AT TORBI toric IOL (Device)

First eye closed loop haptic

Other

subjects implanted with the Closed loop haptic during first eye surgery and the plate haptics toric intraocular lens during second eye surgery

干预措施: T-flex Aspheric Toric IOL (Device)

First eye closed loop haptic

Other

subjects implanted with the Closed loop haptic during first eye surgery and the plate haptics toric intraocular lens during second eye surgery

干预措施: AT TORBI toric IOL (Device)

First eye plate haptic

Other

subjects implanted with the plate haptic toric during first eye surgery and the closed loop haptic toric intraocular lens during second eye surgery

干预措施: T-flex Aspheric Toric IOL (Device)

结局指标

主要结局

Best-corrected visual acuity

时间窗: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months

次要结局

  • IOL centration(Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months))
  • Manifest refraction(Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months))
  • Rotational stability(Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months))
  • Prevalence of posterior capsular Opacification(visit 4 (3-4 months))

研究者

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

Dr Phillip J Buckhurst

Associate Professor (Senior Lecturer)

University of Plymouth

研究点 (1)

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