NCT02968290

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

January 9, 2018

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

November 14, 2016

Last Update Submit

January 8, 2018

Conditions

Posterior Capsule Opacification

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Hydrofobic material-Alcon AcrySof SA60AT

ACTIVE COMPARATOR

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

Procedure: Cataract SurgeryDevice: Alcon AcrySof SA60AT

Hydrophilic material-Bausch Lomb AkreosA

ACTIVE COMPARATOR

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

Procedure: Cataract SurgeryDevice: Bausch Lomb AkreosA

Interventions

Cataract SurgeryPROCEDURE

Implant of intraocular lens hydrophobic or Implant of intraocular lens hydrophilic (Device)

Hydrofobic material-Alcon AcrySof SA60ATHydrophilic material-Bausch Lomb AkreosA
Alcon AcrySof SA60ATDEVICE

Implant of intraocular lens hydrophobic

Hydrofobic material-Alcon AcrySof SA60AT
Bausch Lomb AkreosADEVICE

Implant of intraocular lens hydrophilic

Hydrophilic material-Bausch Lomb AkreosA

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • indication for cataract surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humberto Castro Lima

Salvador, Estado de Bahia, 41830630, Brazil

Location

Related Publications (6)

  • 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.

    PMID: 15640920RESULT

  • 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.

    PMID: 27043393RESULT

  • 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.

    PMID: 23198075RESULT

  • 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.

    PMID: 24992190RESULT

  • 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.

    PMID: 19251151RESULT

  • 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.

    PMID: 23928003RESULT

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of medical residency of ophthalmology and PhD student

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 18, 2016

Study Start

May 1, 2016

Primary Completion

May 30, 2017

Study Completion

November 30, 2017

Last Updated

January 9, 2018

Record last verified: 2017-12

Locations

BR(1)