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Modified Surgical Techniques for Pediatric Cataract Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01844258
First received: April 28, 2013
Last updated: February 23, 2014
Last verified: February 2014
  Purpose

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 Intervention
Cataract
Procedure: Modified technique
Procedure: Traditional technique

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Modified Surgical Techniques for Pediatric Cataract Treatment

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Incidence of opacification of the visual axis [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual function in eyes treated for cataract [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Postoperative complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: March 2013
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

This study is a non-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.
  Eligibility

Ages Eligible for Study:   1 Month to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 1 month and 18 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844258

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

Additional Information:
Publications:

Responsible Party: Haotian Lin, Ophthalmologist, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01844258     History of Changes
Other Study ID Numbers: CCPMOH2010-China3
Study First Received: April 28, 2013
Last Updated: February 23, 2014
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on November 27, 2014