跳至主要内容
临床试验/NCT05194891
NCT05194891
Unknown
不适用

Specular Microscopic Changes of Corneal Endothelial Cells After Phacoemulsification in Patients With Pseudo Exfoliation

Assiut University0 个研究点目标入组 100 人2022年2月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Endothelial Cell Loss, Corneal
发起方
Assiut University
入组人数
100
主要终点
Study of corneal endothelial changes in pseudoexfoliation syndrome
最后更新
4年前

概览

简要总结

this study aimed to evaluate the corneal endothelial cell changes before and after phacoemulsification in pseudoexfoliative patients relative to healthy adults.

详细描述

Pseudoexfoliation syndrome (PEX) is an age related microfibrillopathy disorder characterized by the deposition of greyish white flaky exfoliative material in ocular and extraocular tissue. It commonly affects patients over 50 years old ((commonly in late 60s and 70s) with prevalence range from 0.5% to \> 30%, Although it occurs in virtually every area of the world, a considerable racial variation exists in its incidence. It is relatively rare among African Americans and Eskimos. Prevalence is high in the Sami people who are indigenous of northern Europe. There is also a high prevalence in Arabic populations. It is also well known that patients with PXF develop cataracts early in their lives. Phacoemulsification is a preferred type of cataract surgery owing to fewer complications than other types. However, it still has significant undesirable hazardous as Posterior capsular rupture, vitreous loss, Retinal detachment, Cystoid macular oedema and Posterior capsule opacification. Also, it can enhance loss of corneal endothelial cells, thickness and density that may result in corneal decompensation and subsequent corneal transplantation. In patients with PXF, small pupils and weak zonular support may enhance Phacoemulsification complications. Non-contact Specular microscope is a non-invasive method for morphological analysis of corneal density of endothelial cells, "size change" (Polymegathism), "hexagonal change" (pleomorphism). Therefore, this technology plays an important role in preoperative evaluation, surgical design and postoperative care.

注册库
clinicaltrials.gov
开始日期
2022年2月1日
结束日期
2023年3月
最后更新
4年前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Shymaa Ahmed

Principal Investigator

Assiut University

入排标准

入选标准

  • Patient age is above50 years.
  • Patient with nuclear cataract grade II, III.
  • Clear cornea with no evidence of endothelial disease.
  • Endothelial cell density more than 1000\\mm
  • Normal anterior chamber depth and dilatable pupil.
  • No active ocular disease or inflammation.
  • Pseudoexfoliative patients.

排除标准

  • History of previous trauma, intraocular surgery or ocular surface infection in recent two weeks.
  • Presence of any corneal opacity, endothelial disease, scarring or dystrophies.
  • Pseudoexfoliative glaucoma.
  • Patients age below 50 years.
  • Endothelial cell count less than 1000\\mm2.

结局指标

主要结局

Study of corneal endothelial changes in pseudoexfoliation syndrome

时间窗: Baseline

Comparison of corneal endothelial changes after phacoemulsification in patients with pseudoexfoliation and patient with cataract only

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