Quantification of Posterior Capsule Opacification in Pediatric Cataract

University of Sao Paulo

Status: Completed

Conditions: Posterior Capsule Opacification

Treatments: Device: Bausch Lomb AkreosA; Procedure: Cataract Surgery; Device: Alcon AcrySof SA60AT

Study type: Interventional

Funder types: Other

Identifiers

NCT02968290

University od São Paulo

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• indication for cataract surgery

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Hydrofobic material-Alcon AcrySof SA60AT

Active Comparator group

Description:

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

Treatment:

Procedure: Cataract Surgery

Device: Alcon AcrySof SA60AT

Hydrophilic material-Bausch Lomb AkreosA

Active Comparator group

Description:

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

Treatment:

Device: Bausch Lomb AkreosA

Procedure: Cataract Surgery