Trials / Completed
CompletedNCT02968290
Quantification of Posterior Capsule Opacification in Pediatric Cataract
Quantification of Posterior Capsule Opacity With Software Analysis Comparing Intraocular Lenses Hydrophilic x Hydrophobic in Pediatric Cataracts
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Sao Paulo · Academic / Other
- Sex
- All
- Age
- 5 Years – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Cataract Surgery | Implant of intraocular lens hydrophobic or Implant of intraocular lens hydrophilic (Device) |
| DEVICE | Alcon AcrySof SA60AT | Implant of intraocular lens hydrophobic |
| DEVICE | Bausch Lomb AkreosA | Implant of intraocular lens hydrophilic |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2017-05-30
- Completion
- 2017-11-30
- First posted
- 2016-11-18
- Last updated
- 2018-01-09
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT02968290. Inclusion in this directory is not an endorsement.