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临床试验/NCT05428683
NCT05428683已完成不适用

Assistant Professor, Ophthalmology Department, Al Azhar University

Emad Abdel Aal Saliem1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2020年12月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
1
主要终点
Post operative best corrected visual acuity

研究概览

简要总结

This study aims to evaluate the short-term effects and safety of prophylactic intra-vitreal injection of triamcinolone-moxifloxacin combination after cataract surgery. 84 patients underwent cataract surgery associated with intra-vitreal injection of triamcinolone-moxifloxacin combination after surgery.

详细描述

All the patients underwent the surgical removal of cataract by the same surgeon according to the standard protocols for modern phacoemulsification. Surgery was done under local anesthesia by peri-bulbar injection of local anesthetic. All operations were performed in an operating room by using an operating microscope under complete aseptic condition by using 10% povidone iodine solution applied to the skin of eye lid, eye lashes, side of the nose, eye brow and the skin of forehead. Before the operation, sterile drape and eyelid speculum were used, then 5% povidone iodine solution was applied to the bulbar conjunctiva and fornices for about 5 minutes, then was irrigated by balanced salt solution (BSS).

All the patients were followed up at the 1st day, 1st week, 1st month and at the 3rd month after the operation. At each visit the followings should be assessed: the post-operative refraction, the best corrected visual acuity and anterior and posterior segments examination for any sign of postoperative inflammation as cells and flare. Intra-ocular pressure (IOP) assessment and optical coherence tomography (OCT) images were also taken at the 1st and the 3rd postoperative months to assess the central macular thickness in suspected cases of cystoid macular edema (CME) based upon symptoms or signs observed on fundus examination, were confirmed by OCT of the macula through subjective interpretation via presence of cysts or an objective measurement of retinal thickness > 250 microns.

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
48 Years 至 66 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

prophylactic measures against post-operative inflammations

Other

Usage of triamcinolone and moxifloxacin combination to be injected intravitreally by using 30 G needle.

干预措施: intra-vitreal triamcinolone-moxifloxacin injection after cataract surgery as a prophylactic measures against post-operative endophthalmitis (Drug)

结局指标

主要结局

Post operative best corrected visual acuity

时间窗: at the end of 3rd month.

describe the differences between pre \& post operative best corrected visual acuity by snellen's chart. The mean BCVA showed a statistically significant differences between the preoperative and the postoperative values, where the main BCVA improved from 1.21±0.27 logMAR before operation (at baseline) to 0.19±0.14 logMAR at the 3rd month. For statistical analysis, the best- corrected visual acuity data were transformed to LogMAR. Investigators calculated the mean, standard deviation, range, confidence interval, and Pearson correlation.

A condition of the eye after cataract surgery without use of topical medications.

时间窗: purpose of this study is to evaluate the efficacy of these used drugs after surgery not before it during follow up period at the end of 3rd month.

By SLITLAMP examination, investigators search for signs of postoperative endophthalmitis or inflammations as cells or flare that required supplemental anti-inflammatory medications. So, evaluate the use of triamcinolone-moxifloxacin combination after cataract surgery when injected intra-vitreally against postoperative endophthalmitis and/or other intraocular inflammations without use of topical anti-infective and/or anti-inflammatory medications whether before or even after cataract surgery.

次要结局

未报告次要终点

研究者

发起方
Emad Abdel Aal Saliem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emad Abdel Aal Saliem

Assistant professor

Al-Azhar University

研究点 (1)

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