跳至主要内容
临床试验/NCT02067429
NCT02067429Unknown不适用

Limbal Relaxing Incisions Versus Toric Intraocular Lens for Keratometric Astigmatism <2.5 Diopters in Patients Undergoing Cataract Surgery and Intraocular Lens Implantation.

Christin Henein2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Unaided distance LogMAR visual acuity (UDVA)

研究概览

简要总结

This study will compare toric intra-ocular lens (IOL) with limbal relaxing incisions (LRI) in correcting astigmatism in patient undergoing standard cataract surgery.

Astigmatism is unequal curvature of the eye; the eye is oval rather than spherical. Uncorrected astigmatism of greater than approximately 0.75 diopters (D) can cause visual blurring, ghosting of images or halos. Over 20% of patients undergoing cataract surgery have astigmatism which is likely to have been corrected by spectacles.

Cataract surgery involves the replacement of the natural opacifying crystalline lens with a clear artificial plastic intra-ocular lens (IOL). The lens power can be selected to correct the patient's glasses prescription. The most widely used IOLs only correct glasses at one distance i.e. either near or distance. Residual astigmatism after cataract surgery will need glasses for correction which is undesirable for many patients.

Limbal relaxing incisions (LRI) are circumferential partial thickness cuts to the clear window of the eye (cornea) during surgery. These LRIs can correct corneal astigmatism and have no additional risk of complications.

Alternatively, toric IOLs are available which correct astigmatism inside the eye. They have been available for routine use in the last few years; technology has markedly improved and the lenses have become cheaper.

Studies have suggested toric IOLs provide better vision after cataract surgery than the regular IOLs. Toric IOL are widely used in the private practice and increasingly in the National Health Service (NHS). LRIs are cost effective for treating astigmatism however their predictability is believed to be lower than toric IOLs. As there are no randomised controlled trials comparing the outcomes between LRIs and toric IOLs. This research will address this gap in knowledge and accordingly from this research future practice will be able to provide treatment to patients with information about the best outcomes.

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, Outcomes Assessor)

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

  • Symptomatic cataract for which the patient desires surgery
  • Corneal astigmatism of greater than or equal to 0.75 D and lesser than or equal to 2.5D.
  • No significant ophthalmic co-morbidity which would affect the postoperative visual outcomes.

排除标准

  • <18 years of age
  • Significant ophthalmic comorbidity detrimental to final visual outcomes
  • Not competent to give consent
  • Concurrent use of ocular medications including lubricants
  • Unable to attend follow ups at 1, 3, 6 and 12 months.

结局指标

主要结局

Unaided distance LogMAR visual acuity (UDVA)

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
Christin Henein
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Christin Henein

Academic Foundation Doctor

Sussex Eye Hospital

研究点 (2)

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