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临床试验/NCT06363448
NCT06363448已完成不适用

Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia

Sohag University3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1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
20
试验地点
3
主要终点
Best corrected visual acuity (BCVA) in LogMAR

研究概览

简要总结

The study aims to describe a new method of sulcus fixation of intraocular lenses (IOLs) using a prolene mesh and to compare its outcomes with Yamani technique.

详细描述

Properly positioned posterior chamber IOL (PCIOL) offers many advantages over an anterior chamber IOL (ACIOL). The potential advantages of PCIOLs over ACIOLs include a reduction in the number of optical aberrations (e.g. magnification, aniseikonia, lens edge glare, flutter), a decreased incidence of secondary glaucoma, and free movement of the pupil to control the amount of light entering the eye.

The risk for corneal decompensation, secondary glaucoma, and cystoid macular edema may be less with PCIOLs than with ACIOLs. In the absence of capsular support, many techniques have been described to secure the haptics to the sulcus region.

All described techniques focus on IOL haptics fixation to the scleral wall at two or more points. These techniques are not free of complications, including IOL tilt, misalignment, myopic shift, IOL suture rupture, and dislocation. In a previous study, Othman et al compared classic ab-externo two-point IOL fixation with a new technique of IOL scleral fixation based on fashioning trans-scleral, a double rectangular suture sulcus reconstruction (DRSSR) to support the IOL optic, thus providing a cushion to the IOL being positioned in the sulcus.

Aim of

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
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients aged 40 years
  • aphakic patients (post-traumatic or after complicated cataract surgery without capsular support).

排除标准

  • Corneal decompensation.
  • Jeopardized specular microscopy
  • retinal or choroidal detachment
  • retained Intraocular foreign body
  • uveitis, Scleromalacia
  • Reubeosis irides
  • previous anti-glaucoma surgery.

结局指标

主要结局

Best corrected visual acuity (BCVA) in LogMAR

时间窗: 6 months

Best corrected visual acuity (BCVA) in LogMAR

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

Elshimaa A.Mateen

Assisstant Professor

Sohag University

研究点 (3)

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