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临床试验/NCT02968290
NCT02968290已完成不适用

Quantification of Posterior Capsule Opacity With Software Analysis Comparing Intraocular Lenses Hydrophilic x Hydrophobic in Pediatric Cataracts

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Opacification of posterior capsule measured by graduation through the software EPCO software

研究概览

简要总结

The purpose of this study is to quantify the opacity of posterior capsule in pediatric cataract comparing two intraocular lens materials.

详细描述

The eye exam at the first appointment will consist of anamnesis, external motor, evaluating strabismus and nystagmus, visual acuity with and without correction, biomicroscopy, fundoscopy, binocular ultrasound biometry, pachymetry and specular microscopy. The surgery will be performed by a single surgeon under general anesthesia. All participants will receive primary intraocular lens implantation as the randomization process, or hydrophobic acrylic material or hydrophilic acrylic. The implanted intraocular lens differ primarily in the material. The lens of hydrophobic acrylic materials (AcrySof SA60AT, Alcon Lab) single, folding part, material acrylate / methacrylate with UV protection AcrySof filter, optical diameter of 6.0 mm, total length of 13.0 mm, haptic angle of 0 degree with 360 degree double square edge, spherical convex earlier. The lens hydrophilic acrylic material (Akreos ADAPT, Bausch and Lomb) single, folding piece with optical diameter 6.00 mm and length de10.7 mm aspheric convex in anterior and posterior with absorbent UV, haptic angle 0 degree angulation . It has 4 attachment points (haptics) with 360 degree square double edge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •indication for cataract surgery

排除标准

  • •traumatic cataract
  • •neurological diseases that do not allow the exams

研究组 & 干预措施

Hydrofobic material-Alcon AcrySof SA60AT

Active Comparator

Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrofobic material.

干预措施: Cataract Surgery (Procedure)

Hydrofobic material-Alcon AcrySof SA60AT

Active Comparator

Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrofobic material.

干预措施: Alcon AcrySof SA60AT (Device)

Hydrophilic material-Bausch Lomb AkreosA

Active Comparator

Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrophilic material.

干预措施: Cataract Surgery (Procedure)

Hydrophilic material-Bausch Lomb AkreosA

Active Comparator

Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrophilic material.

干预措施: Bausch Lomb AkreosA (Device)

结局指标

主要结局

Opacification of posterior capsule measured by graduation through the software EPCO software

时间窗: 360 days after cataract surgery

Photodocumentation with camera coupled to slit lamp adapter with external coaxial illumination of a fiber optic cable to the camera. After, analysis of opacification of the posterior capsule through the Evaluation of Posterior Capsule opacification software (EPCO 2000). The EPCO (Evaluation of Posterior Capsule Opacification) software is commercially available and offers some free access. The individual PCO score is calculated by multiplying the density of the opacification by the fraction of capsule area involved behind the IOL optic. It graded the PCO as 0 (none), 1 (minimal), 2 (mild), 3 (moderate) or 4 (severe). EPCO is one of the most used software for this purpose.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

camila ribeiro koch pena

Professor of medical residency of ophthalmology and PhD student

University of Sao Paulo

研究点 (1)

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