Modified Surgical Techniques for Pediatric Cataract Treatment

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT01844258
Collaborator
(none)
37
Enrollment
1
Location
2
Arms
10.1
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Procedure: Modified technique
  • Procedure: Traditional technique
N/A

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 Design

Study Type:
Interventional
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 :
Mar 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Incidence of opacification of the visual axis [six months]

Secondary Outcome Measures

  1. Visual function in eyes treated for cataract [6 months]

Other Outcome Measures

  1. Postoperative complications [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 24 Months
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Zhongshan Ophthalmic Center,Sun Yat-sen UGuangzhouGuangdongChina510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Study Chair: Yizhi Liu, Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Haotian Lin, Ophthalmologist, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01844258
Other Study ID Numbers:
  • CCPMOH2010-China3
First Posted:
May 1, 2013
Last Update Posted:
Dec 22, 2015
Last Verified:
Dec 1, 2015
Keywords provided by Haotian Lin, Ophthalmologist, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 22, 2015