Quantification of Posterior Capsule Opacification in Pediatric Cataract

Not Applicable

Completed

• Conditions: Posterior Capsule Opacification
• Interventions: Procedure: Cataract Surgery; Device: Alcon AcrySof SA60AT; Device: Bausch Lomb AkreosA

• Registration Number: NCT02968290
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-18
• Primary Completion: 2017-05-30
• Study Completion: 2017-11-30
• Status Verified: 2017-12
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• indication for cataract surgery

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrofobic material-Alcon AcrySof SA60AT	Alcon AcrySof SA60AT	Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrofobic material.
Hydrophilic material-Bausch Lomb AkreosA	Cataract Surgery	Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrophilic material.
Hydrophilic material-Bausch Lomb AkreosA	Bausch Lomb AkreosA	Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrophilic material.
Hydrofobic material-Alcon AcrySof SA60AT	Cataract Surgery	Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrofobic material.

Primary Outcome Measures

Name	Time	Method
Opacification of posterior capsule measured by graduation through the software EPCO software	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.

Trial Locations

Locations (1)

Humberto Castro Lima; 🇧🇷 Salvador, Bahia, Brazil