Modified Surgical Techniques for Pediatric Cataract Treatment
|ClinicalTrials.gov Identifier: NCT01844258|
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : December 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Procedure: Modified technique Procedure: Traditional technique||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Modified Surgical Techniques for Pediatric Cataract Treatment|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2014|
Experimental: Modified technique for I/A group
Procedure: Modified technique
Peripheral 1-1.5 mm curvilinear capsulorhexis of anterior capsule
Active Comparator: Traditional technique for I/A group
• In traditional technique group, the cataractous lens will be removed through an anterior continuous curvilinear capsulorhexis (ACCC) that is about 5-6 mm in diameter.
Procedure: Traditional technique
Central 5-6 mm curvilinear capsulorhexis of anterior capsule
- Incidence of opacification of the visual axis [ Time Frame: six months ]
- Visual function in eyes treated for cataract [ Time Frame: 6 months ]
- Postoperative complications [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844258
|Zhongshan Ophthalmic Center,Sun Yat-sen U|
|Guangzhou, Guangdong, China, 510060|
|Study Chair:||Yizhi Liu, Ph.D.||Zhongshan Ophthalmic Center, Sun Yat-sen University|