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临床试验/NCT04122651
NCT04122651Unknown不适用

Randomised, Controlled Study Comparing Use of "Off the Shelf" Toric Lenses, With Set Cylindrical Corrections (2.00D or 4.00D) and Combined Limbal Relaxing Incisions and/or Off-axis Lens Rotation, With Fully Targeted Toric Lens Correction.

Guy's and St Thomas' NHS Foundation Trust0 个研究点目标入组 168 人开始时间: 2019年10月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
168
主要终点
Visual Acuities

研究概览

简要总结

To assess visual performance, refractive outcome, and patient satisfaction with the use of "off the shelf" toric lenses, with a set cylindrical correction of 2.00 or 4.00 diopters, and combined limbal relaxing incisions and/or off-axis intraocular lens rotation, compared to fully targeted toric intraocular lens correction.

详细描述

The aim of this study is to evaluate a simplified, more cost-effective procedure for the use of toric intraocular lenses, with a focus on suitability for NHS cataract surgery. This study will involve the use of standard, "off-the-shelf" toric lenses rather than having them specifically tailored and ordered for each individual patient. Eligible participants (>1.25 D of corneal astigmatism) will be randomised, receiving a toric IOL with either a 2.00 or 4.00 diopter (D) correction, depending on the degree of pre-operative astigmatism, or a toric IOL individually tailored to and ordered for each patients' precise degree of corneal astigmatism. With the "off the shelf" toric IOL group the correction of the astigmatic refractive error will be refined with the use of adjunctive limbal relaxing incisions LRIs and/or off axis rotation of the toric IOL (based on a standardized protocol) so the full amount of corneal astigmatism can be targeted for correction for each patient. The clinical outcome will then be measured and compared between the 2 groups. Independent safety monitoring will be performed.

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
Single (Participant)

盲法说明

Patients will be randomised into one of two groups.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Bilateral or unilateral cataracts requiring surgical intervention
  • Age over 18 years
  • Able to understand informed consent and the objectives of the trial
  • Not pregnant, not breast feeding
  • No previous eye surgery
  • Corneal astigmatism greater than 1.5 diopters in one eye.

排除标准

  • age-related macula degeneration
  • previous retinal vascular disorders
  • previous retinal detachment or tear
  • any neuro-ophthalmological condition
  • any inherited retinal disorder or pathology
  • previous strabismus surgery or record of amblyopia
  • previous TIA, CVA or other vaso-occlusive disease
  • already enrolled in another study

研究组 & 干预措施

Experimental Arm

Experimental

Patients will be receiving a toric intraocular lens with either a 2.00 or 4.00 diopter (D) correction, depending on the degree of pre-operative astigmatism, and the astigmatic refractive error will be refined with the use of adjunctive limbal relaxing incisions LRIs and/or off axis rotation of the toric IOL (based on a standardized protocol) so the full amount of corneal astigmatism can be targeted for correction for each patient.

干预措施: 'Off the shelf' toric lens (Procedure)

Control Arm

Active Comparator

The patient will receive a toric intraocular lens individually tailored to and ordered for each patients' precise degree of corneal astigmatism.

干预措施: Tailored Toric lens (Procedure)

结局指标

主要结局

Visual Acuities

时间窗: 6 months

Corrected and uncorrected Logmar Visual Acuities

Refractive Error

时间窗: 6 months

次要结局

  • Patient Satisfaction(6 months)
  • Intraoperative and post operative complications(0 day-6 months)

研究者

申办方类型
Other
责任方
Sponsor

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