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Quantification of Posterior Capsule Opacification in Pediatric Cataract (Cataract)

Primary Purpose

Posterior Capsule Opacification

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cataract Surgery
Alcon AcrySof SA60AT
Bausch Lomb AkreosA
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Posterior Capsule Opacification

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • indication for cataract surgery

Exclusion Criteria:

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

Sites / Locations

  • Humberto Castro Lima

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hydrofobic material-Alcon AcrySof SA60AT

Hydrophilic material-Bausch Lomb AkreosA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 14, 2016
Last Updated
January 8, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02968290
Brief Title
Quantification of Posterior Capsule Opacification in Pediatric Cataract
Acronym
Cataract
Official Title
Quantification of Posterior Capsule Opacity With Software Analysis Comparing Intraocular Lenses Hydrophilic x Hydrophobic in Pediatric Cataracts
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Capsule Opacification

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrofobic material-Alcon AcrySof SA60AT
Arm Type
Active Comparator
Arm Description
Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrofobic material.
Arm Title
Hydrophilic material-Bausch Lomb AkreosA
Arm Type
Active Comparator
Arm Description
Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrophilic material.
Intervention Type
Procedure
Intervention Name(s)
Cataract Surgery
Intervention Description
Implant of intraocular lens hydrophobic or Implant of intraocular lens hydrophilic (Device)
Intervention Type
Device
Intervention Name(s)
Alcon AcrySof SA60AT
Intervention Description
Implant of intraocular lens hydrophobic
Intervention Type
Device
Intervention Name(s)
Bausch Lomb AkreosA
Intervention Description
Implant of intraocular lens hydrophilic
Primary Outcome Measure Information:
Title
Opacification of posterior capsule measured by graduation through the software EPCO software
Description
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.
Time Frame
360 days after cataract surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: indication for cataract surgery Exclusion Criteria: traumatic cataract neurological diseases that do not allow the exams
Facility Information:
Facility Name
Humberto Castro Lima
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41830630
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15640920
Citation
Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.
Results Reference
result
PubMed Identifier
27043393
Citation
Gasper C, Trivedi RH, Wilson ME. Complications of Pediatric Cataract Surgery. Dev Ophthalmol. 2016;57:69-84. doi: 10.1159/000442502. Epub 2016 Apr 1.
Results Reference
result
PubMed Identifier
23198075
Citation
Panahi-Bazaz MR, Zamani M, Abazar B. Hydrophilic Acrylic versus PMMA Intraocular Lens Implantation in Pediatric Cataract Surgery. J Ophthalmic Vis Res. 2009 Oct;4(4):201-7.
Results Reference
result
PubMed Identifier
24992190
Citation
Lin H, Yang Y, Chen J, Zhong X, Liu Z, Lin Z, Chen W, Luo L, Qu B, Zhang X, Zheng D, Zhan J, Wu H, Wang Z, Geng Y, Xiang W, Chen W, Liu Y; CCPMOH Study Group. Congenital cataract: prevalence and surgery age at Zhongshan Ophthalmic Center (ZOC). PLoS One. 2014 Jul 3;9(7):e101781. doi: 10.1371/journal.pone.0101781. eCollection 2014.
Results Reference
result
PubMed Identifier
19251151
Citation
Werner L, Tetz M, Feldmann I, Bucker M. Evaluating and defining the sharpness of intraocular lenses: microedge structure of commercially available square-edged hydrophilic intraocular lenses. J Cataract Refract Surg. 2009 Mar;35(3):556-66. doi: 10.1016/j.jcrs.2008.11.042.
Results Reference
result
PubMed Identifier
23928003
Citation
Kleinmann G, Zaugg B, Apple DJ, Bleik J. Pediatric cataract surgery with hydrophilic acrylic intraocular lens. J AAPOS. 2013 Aug;17(4):367-70. doi: 10.1016/j.jaapos.2013.04.007. Epub 2013 Aug 6.
Results Reference
result

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Quantification of Posterior Capsule Opacification in Pediatric Cataract

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