Modified Surgical Techniques for Pediatric Cataract Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01844258
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : December 22, 2015
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Cataract Procedure: Modified technique Procedure: Traditional technique Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Modified technique for I/A group
  • In the modified cataract surgery procedure, the size of the capsulorhexis opening will be decreased to 1.0-1.5 mm in diameter.
  • The capsulorhexis will be located in the peripheral area of the lens instead of the central area.
  • A 0.9 mm phacoemulsification probe will be used to remove the cataractous lens.
  • One drop of 0.5% or 1% atropine and an antibiotic/steroid ointment will be placed in the eye, which will then be patched.
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

Primary Outcome Measures :
  1. Incidence of opacification of the visual axis [ Time Frame: six months ]

Secondary Outcome Measures :
  1. Visual function in eyes treated for cataract [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Postoperative complications [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 1 month and 24 months
  • Uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes with an intact non-fibrotic capsular bag
  • Informed consent signed by a parent or legal guardian

Exclusion Criteria:

  • Intraocular pressure >21 mmHg
  • Preterm birth (<28 weeks)
  • Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy)
  • History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family
  • History of ocular trauma
  • Microcornea
  • Persistent hyperplastic primary vitreous
  • Rubella
  • Lowe syndrome

Information from the National Library of Medicine

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 identifier (NCT number): NCT01844258

China, Guangdong
Zhongshan Ophthalmic Center,Sun Yat-sen U
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Study Chair: Yizhi Liu, Ph.D. Zhongshan Ophthalmic Center, Sun Yat-sen University

Additional Information:

Responsible Party: Haotian Lin, Ophthalmologist, Sun Yat-sen University Identifier: NCT01844258     History of Changes
Other Study ID Numbers: CCPMOH2010-China3
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015

Keywords provided by Haotian Lin, Sun Yat-sen University:
pediatric cataract
lens regeneration
endogenous lens epithelial stem cells
visual axis opacification
visual function

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases