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临床试验/NCT06896357
NCT06896357尚未招募1 期

Effectiveness and Safety of Limbal Relaxing Incisions for Correcting Post Phacoemulsification High Astigmatism

Assiut University0 个研究点目标入组 30 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
30
主要终点
contrast sensitivity improvement

研究概览

简要总结

To compare the effect of Limbal relaxing incisions (LRIs) plus spectacle correction versus spectacle correction alone on subjective and objective improvement in visual function for correcting post phacoemulsification high astigmatism .

详细描述

Astigmatism is one of the commonest refractive errors encountered during our clinical practice. Surgically induced astigmatism is the main obstacle to achieve good uncorrected visual acuity following cataract surgery. It is estimated that corneal astigmatism of more than 1.0 diopter (D) is found in up to 40% of patients presenting for cataract surgery, 1.5D or more is present in over 20% and above 2.0D in 10%.

Astigmatism induces distortion of the image leading to compromise quality of vision. In order to achieve better visual results, the effect of postoperative astigmatism should be minimized, management options for corneal astigmatism include glasses, contact lenses, and surgery such as Limbal relaxing incisions (LRIs), refractive laser surgery, toric lenses or rarely corneal grafting. The LRIs technique involves the placement of incisions corresponding to the steep meridian, resulting in corneal flattening and the reduction of astigmatic power. LRI is a safe and an inexpensive procedure, which is simple for experts to perform. Although most of the nomograms recommended that LRIs technique can correct up to 3 D of astigmatism ,it has been found that it is possible to correct even more than 4 D if the incisions were performed on high degrees of astigmatism.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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
否

入选标准

  • •Conventional phacoemulsification was done at least one month earlier.
  • •Clear cornea with corneal astigmatism more than 3.0 D.

排除标准

  • •History of corneal surgeries (e.g., keratoplasty, refractive surgery, and corneal wound repair).
  • •Ocular trauma.
  • •Other intraocular surgery.
  • •Patient with corneal opacities.
  • •Thin cornea .
  • •Any significant ocular disease causing diminution of vision (e.g., optic atrophy, diabetic retinopathy, and age-related macular degeneration), autoimmune disease, and peripheral corneal disease.

研究组 & 干预措施

patients with post phacoemulsification high astigmatism .

Experimental

干预措施: Limbal relaxing incisions (Procedure)

结局指标

主要结局

contrast sensitivity improvement

时间窗: 3 months

Assessment the improvement in contrast sensitivity using Pelli-Robson contrast sensitivity test .

visual acuity improvement

时间窗: 3 months

assessment the improvement in visual acuity ,which will be measured by Landolt Cs chart with decimal notation.

次要结局

未报告次要终点

研究者

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

Youstina shaheir shawky gad

resident doctor of ophthalmology

Assiut University

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