Quantification of Posterior Capsule Opacification in Pediatric Cataract (Cataract)

January 8, 2018 updated by: camila ribeiro koch pena, University of Sao Paulo

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 41830630
        • Humberto Castro Lima

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • indication for cataract surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
360 days after cataract surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

May 30, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University od São Paulo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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