Status:
WITHDRAWN
Clinical Evaluation of the Use of Sealed Capsule Irrigation With Sodium Chloride During Pediatric Cataract Surgery and IOL Implantation
Lead Sponsor:
Medical University of South Carolina
Conditions:
Cataract Extraction
Eligibility:
All Genders
4-18 years
Phase:
PHASE4
Brief Summary
This study involves using both a device that seals the capsular bag (where the lens is located) allowing safer irrigation of the capsular bag and sodium chloride to irrigate the capsular bag during ca...
Detailed Description
Dramatic advances have occurred in the treatment of childhood cataracts in the last 10 years. Intraocular lens implantation (IOL) has been universally accepted as standard of care in children beyond 2...
Eligibility Criteria
Inclusion
- bilateral cataract
- 4 - 18 years of age
- Informed consent from the parents/legal guardian.
Exclusion
- traumatic cataract
- fellow eye - visually not significant cataract
- fellow eye surgery not planned during the study enrollment period
- weak or compromised posterior or anterior capsule
- dense posterior capsule plaque
- preexisting posterior capsule defect
- capsulorhexis diameter\>5 mm
- radial capsular tears
- defects within the remaining capsular bag
- inability to visualize the entire capsulorhexis
- shallow anterior chamber
- very high vitreous pressure
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00366613
Start Date
July 1 2005
End Date
August 1 2007
Last Update
July 23 2018
Active Locations (1)
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1
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, United States, 29425