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Trial record 31 of 1150 for:    cataract

Quantification of Posterior Capsule Opacification in Pediatric Cataract (Cataract)

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ClinicalTrials.gov Identifier: NCT02968290
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
camila ribeiro koch pena, 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.

Condition or disease Intervention/treatment Phase
Posterior Capsule Opacification Procedure: Cataract Surgery Device: Alcon AcrySof SA60AT Device: Bausch Lomb AkreosA Not Applicable

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  (Clinical Trial)
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 : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • indication for cataract surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968290


Locations
Brazil
Humberto Castro Lima
Salvador, Bahia, Brazil, 41830630
Sponsors and Collaborators
University of Sao Paulo

Publications of Results:
Responsible Party: camila ribeiro koch pena, Professor of medical residency of ophthalmology and PhD student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02968290     History of Changes
Other Study ID Numbers: University od São Paulo
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Cataract
Capsule Opacification
Lens Diseases
Eye Diseases