Quantification of Posterior Capsule Opacification in Pediatric Cataract

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

Detailed Description
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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.

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

Conditions
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Posterior Capsule Opacification

Intervention / Treatment
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* Procedure: Cataract Surgery
* Device: Alcon AcrySof SA60AT
* Device: Bausch Lomb AkreosA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication for cataract surgery Exclusion Criteria: traumatic cataract neurological diseases that do not allow the exams

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydrofobic material-Alcon AcrySof SA60AT<br>Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrofobic material. | Procedure: Cataract Surgery<br>* Implant of intraocular lens hydrophobic or Implant of intraocular lens hydrophilic (Device)<br>Device: Alcon AcrySof SA60AT<br>* Implant of intraocular lens hydrophobic<br>|
| Active Comparator: Hydrophilic material-Bausch Lomb AkreosA<br>Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrophilic material. | Procedure: Cataract Surgery<br>* Implant of intraocular lens hydrophobic or Implant of intraocular lens hydrophilic (Device)<br>Device: Bausch Lomb AkreosA<br>* Implant of intraocular lens hydrophilic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opacification of posterior capsule measured by graduation through the software EPCO software | 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. | 360 days after cataract surgery |