Congenital Cataract Clinical Trial
Official title:
Aphakia vs Pseudophakia - Randomized Clinical Trial in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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