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临床试验/NCT04323982
NCT04323982Unknown不适用

Comparison of Traditional Cataract Surgery and Traditional Surgery Combine Triamcinolone Staining of the Anterior Vitreous in Treating Congenital Cataracts

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年3月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
incidence of high intraocular pressure

研究概览

简要总结

Previously, the investigators have developed a surgical technique to reduce inflammatory response after congenital cataract surgery. This prospective, randomized controlled study aims to compare the prognosis of traditional cataract surgery with traditional surgery combined triamcinolone staining of the anterior vitreous in treating congenital cataracts.

详细描述

Surgical technique for congenital cataract is now more and more mature, but many young patients still have obvious postoperative inflammatory response, which might cause visual axial opacification, posterior synechiae and secondary glaucoma. Triamcinolone is used in intraocular injection for its anti-inflammatory effect However, the application of Triamcinolone was reported to be associated with high intraocular pressure. It is necessary to evaluate the safety and effectiveness of using triamcinolone in congenital cataract surgery.

In this randomized clinical trial, children with equal degree of congenital cataract in both eyesare enrolled. Patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo traditional surgical procedure, while the fellow eye is undergoing new surgical procedure. The traditional surgical procedure include anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), posterior continuous curvilinear capsulorhexis (PCCC), and anterior vitrectomy(A-VIT). Primary intraocular lens implantation (IOL) is performed in children older than age of two. The new surgical procedure is to combine triamcinolone staining of the anterior vitreous on the basis of the traditional surgical procedure. Investigators then compare the incidence of high intraocular pressure, visual axis opacification, uveitis, iris/pupil abnormality, and macular edema between two groups

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
Single (Participant)

入排标准

年龄范围
3 Months 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 3 months and 13 years
  • Uncomplicated bilateral same degree of congenital cataract (≥ 3 mm central dense opacity)
  • Informed consent signed by a parent or legal guardian

排除标准

  • Intraocular pressure >21 mmHg
  • Preterm birth (<28 weeks)
  • Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma, microcornea, persistent hyperplastic primary vitreous) or systemic disease (congenital heart disease, ischemic encephalopathy)
  • History of ocular trauma
  • Previous intraocular surgery

结局指标

主要结局

incidence of high intraocular pressure

时间窗: 5 years

Determined with the Tono-pen.

incidence of visual axis opacification

时间窗: 5 years

Visual axis obscuration will be evaluated based on the retroillumination.

incidence of uveitis and iris/pupil abnormality

时间窗: 5 years

Uveitis and iris/pupil abnormality will be evaluated based on the slip lamp examination.

次要结局

  • Central corneal thickness(5 years)
  • Best corrected visual acuity(5 years)
  • Central macular thickness(5 years)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haotian Lin

Clinical Professor

Sun Yat-sen University

研究点 (1)

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