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临床试验/NCT02581046
NCT02581046已完成不适用

Effect of the Timing of Lens-removal Cataract Surgery on Postoperative Complications Rate Among Patients With Bilateral Congenital Cataracts

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2011年1月最近更新:
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
61
试验地点
1
主要终点
Change from baseline in the thickness of the outer retinal layer regions measured by Optical Coherence Tomography(OCT)

研究概览

简要总结

Congenital cataract is an important treatable cause of visual handicap in childhood throughout the world. Successful management of childhood cataract is dependent on individualized treatment strategies and rigorous postoperative supervision for adverse complication. In this trial, we aimed to compare the difference of postoperative outcome between surgical timing at age of 3 month and 6 month. Patients enrolled into the study will be followed for two year and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month, 18month and 24month postoperatively.

详细描述

Congenital cataract is a priority of Vision 2020: the Right to Sight, the global initiative to reduce the world's burden of avoidable blindness, because it is an important treatable cause of visual handicap in childhood throughout the world. Successful management of childhood cataract is dependent on individualized treatment strategies and postoperative supervision for adverse complication is also essential. The timing of surgery of childhood cataract depends on the etiology and on the degree of visual interference. Severe bilateral cataracts with significant obstruction of the visual axis must be treated and surgery is recommended as soon as possible after discovery.

Several previous studies claimed that ideally cataracts should be removed before 3 months of age, while the result of recent researches shows that too early intervention for cataract surgery seems aggressive and would cause serious complications, which might cause poor long-term visual outcomes. Therefore, in order to control childhood blindness and severe visual impairment in China, it is of great importance to ensure that pediatric patients with cataract could have good timing of surgery, postoperative rigorous supervision, accurate optical rehabilitation and comprehensive treatment of amblyopia.

In this trial, we aimed to compare the difference of postoperative outcome between surgical timing at age of 3 month and 6 month. Patients enrolled into the study will be followed for two year and will have study visits at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months, 18months and 24months after cataract surgery.

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
— 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children diagnosis with bilateral congenital cataract for entire lens without other ocular abnormality
  • No more than 3 month old
  • Have signed a consent form
  • Can be followed

排除标准

  • Children not identified with congenital cataract
  • Have not signed consent form
  • Be not able to be followed

研究组 & 干预措施

3 month surgical group

Experimental

Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation.

干预措施: Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 3month of the patients (Procedure)

3 month surgical group

Experimental

Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation.

干预措施: Subconjunctival dexamethasone and general anesthesia (Drug)

6 month surgical group

Experimental

Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation..

干预措施: Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 6 month of the patients (Procedure)

6 month surgical group

Experimental

Phacoemulsification pediatric cataract surgery is performed at the age of 3 month of patients without IOL implantation..

干预措施: Subconjunctival dexamethasone and general anesthesia (Drug)

结局指标

主要结局

Change from baseline in the thickness of the outer retinal layer regions measured by Optical Coherence Tomography(OCT)

时间窗: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month

Change from baseline in the central subfield thickness (CST) measured by Optical Coherence Tomography(OCT)

时间窗: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month

Change from baseline in the thickness of the inner retinal layer regions measured by Optical Coherence Tomography(OCT)

时间窗: during surgery,postoperation time:1day,1week,1month,3month,6month,9month,12month,18month,24month

次要结局

  • Number of participants with abnormal intraocular pressure or diagnosis with secondary glaucoma(2 year after surgery)
  • Number of participants undergoing Nd:YAG laser capsulotomy due to severe posterior capsular opacification(PCO)(2 year after surgery)

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

Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center

Sun Yat-sen University

研究点 (1)

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