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临床试验/NCT01494974
NCT01494974Unknown4 期

Comparison of the Ahmed Glaucoma Valve FP7 and FP8 in Pediatric Glaucoma: a Randomized Clinical Trial.

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年12月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
发起方
入组人数
40
试验地点
1
主要终点
Position of the drainage implant plate

研究概览

简要总结

The purpose of this study is to compare the success rates and complications of two models of Ahmed glaucoma implants (FP7 and FP8) in patients with pediatric glaucoma.

详细描述

INTRODUCTION

The drainage implants have become an important alternative in the treatment of pediatric glaucoma refractory to angular and filtration surgery or medical therapy (1). Such implants drain the aqueous humor from the anterior chamber of the eye to a plate positioned above the sclera, between the rectus muscles. The aqueous humor goes through the pseudocyst that forms around the plate by passive diffusion and is drained by the venous capillaries and lymphatic system.

The Ahmed drainage implant (New World Medical, Inc., Rancho Cucamonga, CA, USA) is a device with flow restrictors, which decreases the incidence of postoperative complications such as hypotony (2-3). It is made of silicone and comes in two sizes. The FP7 model has a surface of 184 mm2, 13mm wide and 16mm long. The FP8 model presents 96mm2 surface, 9.6 mm wide and 10mm long.

Studies in animals and adult humans suggest that the surface area of the implant plate is directly related to the amount of aqueous fluid drained through the same (4-7). In contrast, a very large implant can result in the extrusion of the same, uncontrolled intraocular pressure, corneal injury by endothelial touch, patient discomfort and ocular motility problems. The use of pediatric size implants in small eyes can avoid such complications. A high rate (34.8%) of anterior plate of the tubes in children under 2 years of age has been reported (8-9). On the other hand, the use of pediatric implante may affect the control of intraocular pressure (IOP) due to reduced drainage area (10), especially in eyes with increasing axial diameter, a result of increased eye pressure that happens in children with glaucoma. However, there is no study in the literature comparing different sizes of drainage implants in pediatric patients.

A study to compare the success rates and complications between FP7 and FP8 models is essential in order to standardize a conduct in choosing the type of implant. Currently, the choice of the drainage implant model to be used in every child lies on the free choice and personal preference of the surgeon. There is no standard procedure, based on scientific evidence for this choice.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnostic of Pediatric Glaucoma with indication of Ahmed Glaucoma Valve implantation
  • •Age from 0 to 10 years old

排除标准

  • •Children older then 10 years old

研究组 & 干预措施

FP7 implant

Active Comparator

干预措施: FP7 Ahmed Glaucoma Drainage Implant (Device)

FP8 implant

Active Comparator

干预措施: FP8 Glaucoma Drainage Implant (Device)

结局指标

主要结局

Position of the drainage implant plate

时间窗: After 1 year of surgery

The primary endpoint is to evaluate the position of the drainage implant plate and if the plate is positioned at a distance ≥ 8 mm from the corneal limbus after 1 year of surgery, considered successful. If the plate is positioned at a distance \<8 mm from the corneal limbus, we have a failure.

次要结局

  • As a secondary outcome, we evaluate the variation in IOP preoperative and postoperative.(After 1 year of surgery)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Camila Fonseca Netto

MD

Federal University of São Paulo

研究点 (1)

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