Quantification of Posterior Capsule Opacification in Pediatric Cataract

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT02968290

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Posterior Capsule Opacification	Procedure: Cataract Surgery Device: Alcon AcrySof SA60AT Device: Bausch Lomb AkreosA	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

May 30, 2017

Actual Study Completion Date :

Nov 30, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

indication for cataract surgery

Exclusion Criteria:

traumatic cataract
neurological diseases that do not allow the exams

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Humberto Castro Lima	Salvador	Bahia	Brazil	41830630

Sponsors and Collaborators

University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

camila ribeiro koch pena, Professor of medical residency of ophthalmology and PhD student, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT02968290

Other Study ID Numbers:

University od São Paulo

First Posted:

Nov 18, 2016

Last Update Posted:

Jan 9, 2018

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Cataract

Capsule Opacification

Study Results

No Results Posted as of Jan 9, 2018