跳至主要内容
临床试验/NCT06974578
NCT06974578已完成不适用

Assessment of the Outcomes of Routine Insertion of Capsular Tension Ring (CTR) With Hydrophilic Versus Hydrophobic Intraocular Lenses (IOLs) Alone After Phacoemulsification

Benha University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月8日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Change in BCVA (LogMAR)

研究概览

简要总结

evaluate the clinical outcomes of routine CTR insertion in conjunction with hydrophilic versus hydrophobic IOLs following phacoemulsification.

详细描述

Phacoemulsification with intraocular lens (IOL) implantation is the standard surgical approach for cataract extraction. The choice between hydrophilic and hydrophobic IOLs has been debated, with studies suggesting differences in posterior capsule opacification (PCO) rates and capsular bag stability. Capsular tension rings (CTRs) are devices designed to stabilize the capsular bag, particularly in cases with zonular weakness. While CTRs are beneficial in complex cases, their routine use remains controversial. Understanding the interaction between CTRs and IOL materials could inform surgical practices and improve patient outcomes

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Adults aged 40-80 years.
  • Visually significant cataract (≥3+ on Lens Opacities Classification System III "LOCSIII").
  • Clear cornea.

排除标准

  • • Previous ocular surgery.
  • Zonular instability requiring CTR insertion beyond routine practice.
  • Complicated cataract cases (e.g., traumatic cataract).
  • Active intraocular inflammation or infection.

结局指标

主要结局

Change in BCVA (LogMAR)

时间窗: at 1, 3, and 6 months postoperatively.

The formula: logMAR score (0.1 NL + 0.02 nl) where NL = number of lines completely read and nl = number of additional letters read ap- plies. For this method, the higher the logMAR VA score, the better the visual acuity.

Refractive error measurements (spherical equivalent)

时间窗: at 1, 3, and 6 months postoperatively.

SE was calculated as the spherical power of the refractive error plus one-half of the cylinder power. Hyperopia was defined as a spherical equivalent (SE) values of ≥ + 1.00 diopter (D) and emmetropia as a SE ranging between 0.99 and - 0.49 D. Myopia was defined as a SE refraction of ≤ -0.50 D.

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

Ehab Mohamed Elsayed Mohamed Saad

Lecturer

Benha University

研究点 (1)

Loading locations...

相似试验