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临床试验/NCT05136209
NCT05136209招募中不适用

Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy in Congenital Cataract Surgery

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: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Number of participants with visual axis opacification

研究概览

简要总结

Selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. This prospective, randomized controlled study aims to compare the prognosis of posterior continuous curvilinear capsulorhexis (PCCC) with or without anterior vitrectomy (A-Vit) in treating congenital cataracts.

详细描述

Due to the particularity of children's eye structure, selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. The major concerned postoperative problem is the after-cataract formation. As a result, PCCC with A-Vit is usually performed to prevent the formation of secondary cataracts. However. Debate over the indication and surgical procedure still persists since A-Vit and excessive manipulations may interfere with the development of the eye and increase the risk of postoperative inflammation, unstable intraocular pressure, macular edema, retinal detachment and so on. Thus, it is necessary to evaluate the safety and effectiveness of PCCC without A-Vit in congenital cataract surgery.

In this randomized clinical trial, children with equal degree of congenital cataract in both eyes are enrolled. Patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo PCCC+A-Vit procedure, while the fellow eye is undergoing PCCC procedure without A-Vit. PCCC+A-Vit procedure includes anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), PCCC, and A-Vit. Primary intraocular lens implantation (IOL) is performed in children older than age of two. Investigators then compare the incidence of visual axis opacity, uveitis, iris/pupil abnormality and intraocular pressure 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 (Outcomes Assessor)

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children with bilateral congenital cataracts without other ocular abnormalities
  • Gestational age at birth >37 weeks
  • No more than 18 years old
  • Pupils could dilate normally pre-operation
  • Have signed a consent form
  • Can be followed

排除标准

  • Intraocular pressure >21 mmHg
  • History of ocular trauma and intraocular surgery

结局指标

主要结局

Number of participants with visual axis opacification

时间窗: 5 years

Number of participants with visual axis opacification evaluated based on the retro-illumination.

Number of participants with uveitis and iris/pupil abnormality

时间窗: 5 years

Number of participants with uveitis and iris/pupil abnormality evaluated based on the slip lamp examination.

IOP

时间窗: 5 years

Intraocular pressure measured by the Tono-pen or non-contact tonometer

次要结局

  • CCT change(5 years)
  • AL change(5 years)
  • BCVA change(5 years)
  • CFT change(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

Prof.

Sun Yat-sen University

研究点 (1)

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