Clinical trial NCT02968290: Quantification of Posterior Capsule Opacification in Pediatric Cataract
Official title: Quantification of Posterior Capsule Opacity With Software Analysis Comparing Intraocular Lenses Hydrophilic x Hydrophobic in Pediatric Cataracts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Capsule Opacification
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* indication for cataract surgery

Exclusion Criteria:

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

Primary outcomes:
measure: Opacification of posterior capsule measured by graduation through the software EPCO software
timeFrame: 360 days after cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Humberto Castro Lima
state: Bahia
Study officials:
References:
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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.
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.
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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.