Clinical Trial: Quantification of Posterior Capsule Opacification in Cataract Pediatric.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: University of Sao Paulo

Current Primary Outcome: Opacification of posterior capsule measured by graduation through the software EPCO software [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Sao Paulo

Dates:
Date Received: November 14, 2016
Date Started: August 2016
Date Completion: January 2018
Last Updated: November 20, 2016
Last Verified: November 2016