NCT01297153

Aphakia Versus Pseudophakia in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery

Aphakia vs Pseudophakia - Randomized Clinical Trial in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Iladevi Cataract and IOL Research Center · Academic / Other
• Sex: All
• Age: 24 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to document the safety and efficacy of primary IOL implantation in children below 2 years of age undergoing congenital cataract surgery.

Detailed description

The use of IOLs in pediatric patients has become increasingly popular in recent years and may represent a standard of care for older children. The refinements in surgical techniques attained in adult cataract surgery have been translated to pediatric cataract surgery to produce a technically safe eye. Nevertheless, the use of IOLs in children younger than 2 years remains controversial. Exaggerated inflammation, capsular opacification and changing refractive status of the developing eye should be considered before the use of IOLs in the first two years of life. Further more, there is concern about the unknown risks of an IOL over the long life span. Currently, there are 3 methods of optical rehabilitation following congenital cataract surgery : 1. Primary IOL implantation. 2. Aphakic glasses. 3. Contact lenses. At present, there is no randomized clinical trial reported to document the safety and efficacy of IOL implantation in children less than 2 years. Aim : To compare the technical outcome (safety) and functional outcome (benefits) following primary IOL implantation and aphakia in children less than 2 years.

Conditions

• Congenital Cataract

Interventions

Type	Name	Description
DEVICE	Intraocular Lens (Acrysof IOL)	IOL fixation, material and size are important determinants of immediate and long-term outcome. In-the-bag fixation is the most preferred site of IOL implantation.
DEVICE	No IOL	No IOL will be implanted in these eyes

Timeline

• Start date: 2003-05-01
• Primary completion: 2011-01-01
• Completion: 2011-05-01
• First posted: 2011-02-16
• Last updated: 2011-07-01

Locations

1 site across 1 country: India