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临床试验/NCT04334473
NCT04334473已完成不适用

Intraocular Pressure and Ocular Biometrics Changes After Phacoemulsification in Glaucomatous Patients and Age Matched Controls, Comparative Study

Mai Nasser Abd Elmohsen2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2019年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
ocular bio-metrics change

研究概览

简要总结

Effect of phacoemulsification on intraocular pressure has been studied with variable results.Furthermore, effect of phacoemulsification on ocular biometrics including anterior chamber depth and angle opening distance has also been studied. In our study we aim at establishing a quantitative relationship between preoperative ocular biometrics and postoperative intraocular pressure change and comparing this relationship in glaucomatous and non-glaucomatous eyes.

详细描述

All patients will have the anterior chamber angle assessed by indentation gonioscopy preoperatively. Anterior Chamber Depth & lens thickness will be measured by Optical Biometry (lenstar 900) as well as measurement of the angle & lens vault using the Ultrasound Biomicrosopy (UBM) before and 1 month after cataract surgery. IOP will be measured pre- & postoperatively on day 7 and 30. Possible Risk (s): Risks of surgery(hemorrhage, endophthalmitis), Risks for investigations: minimal risk of infection To minimize the risk of infection: adherence to pre-& intraoperative infection-control measures, postoperative UBM is to be done at 1 month.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

  • Age 40-70 years.
  • Glaucomtous and nonglaucomatous participants with visually significant cataracts.
  • Best-corrected visual acuity (BCVA) equal to or worse than 6/
  • patients candidates for standard cataract surgeries without adjunctive procedure (e.g., pupil stretching or iris hooks).

排除标准

  • Major intraoperative or postoperative complications from cataract surgery
  • Peripheral anterior synechiae (PAS) detected by indentation gonioscopy.
  • Uveitis, severe retinal diseases, or congenital Anomalies.
  • History of ocular trauma or any intraocular Surgery. ocular trauma or any intraocular Surgery

结局指标

主要结局

ocular bio-metrics change

时间窗: 4 weeks

anterior chamber angle angle opening distance and anterior chamber depth change

Intraocular pressure change

时间窗: 4 weeks

intraocular pressure measurement by Goldman's applanation tonometr

次要结局

  • Phacoemulsification as treatment to glaucoma(4 weeks)

研究者

发起方
Mai Nasser Abd Elmohsen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mai Nasser Abd Elmohsen

Lecturer of ophthalmology

Kasr El Aini Hospital

研究点 (2)

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