Modified Surgical Techniques for Pediatric Cataract Treatment
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Pediatric cataract is totally different from adult cataract. There is traditionally no
      difference in technique between pediatric and adult cataract surgery. Opacification of the
      visual axis was the most frequent complication after pediatric surgery. In this clinical
      study, the investigators aimed to evaluate the safety and postoperative recovery of a
      modified technique for pediatric cataract surgery.
    

Detailed description: 
      This study is a randomized, controlled clinical trial with the following objectives:

        -  To determine whether infants with congenital cataract have improved visual outcomes
           following cataract extraction surgery using (1) the traditional capsulorhexis method or
           (2) our new minimally invasive method.

        -  To determine the occurrence of postoperative complications among infants with congenital
           cataract following cataract extraction surgery using (1) the traditional capsulorhexis
           method or (2) our new minimally invasive method.

      The study is conducted for the following reasons:

        -  Transplantation of pluripotent stem cells represents an appealing therapeutic strategy
           in regenerative medicine, but its clinical applications have been hindered in part by
           concerns about tumorigenicity and immune rejection. The use of endogenous stem cells
           provides a possible solution to this problem.

        -  Lens regeneration has been reported in lower vertebrate animals. Furthermore, residual
           endogenous lens epithelial stem cells (LESCs) after lens removal in rabbits have been
           shown to proliferate and generate lens fibers.

        -  Cataract, or opacification of the lens, is a major cause of blindness worldwide. Surgery
           for congenital cataract carries a significant risk of complications and often requires
           additional surgical procedures to maintain the transparency of the visual axis.

        -  Implantation of intraocular lenses (IOLs) following cataract extraction is becoming
           increasingly common in the pediatric population. However, their use is controversial in
           children younger than two years old (especially not recommended in children younger than
           6 months old due to the high incidences of IOL-related complications), as the refractive
           power of the eye continues to develop. In addition, IOLs have many limitations,
           including dislocation, less than ideal biocompatibility, inadequate accommodative
           properties, and suboptimal visual outcomes.

        -  The trial will demonstrate whether a modified cataract surgical technique can regenerate
           the lens from endogenous stem cells. It will also compare the incidence of complications
           and characterize visual outcomes in pediatric patients treated with the modified
           surgical technique versus the traditional surgical technique.
    

Intervention name(s): Modified technique; Traditional technique
Intervention type(s): Procedure; Procedure
Intervention description(s): Peripheral 1-1.5 mm curvilinear capsulorhexis of anterior capsule; Central 5-6 mm curvilinear capsulorhexis of anterior capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric cataract; lens regeneration; endogenous lens epithelial stem cells; visual axis opacification; visual function