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Clinical Evaluation of the Use of Sealed Capsule Irrigation With Sodium Chloride During Pediatric Cataract Surgery and IOL Implantation

This study has been withdrawn prior to enrollment.
(We wish to wait until there is more data available using this substance.)
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00366613
First received: August 17, 2006
Last updated: October 2, 2007
Last verified: August 2007
History of Changes
  Purpose

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 cataract surgery on children. The purpose of this study is to determine if the use of the device, Perfect Capsule, along with sodium chloride reduces the development of posterior capsule opacification (PCO), a possible complication of cataract surgery. PCO is the clouding of the rear portion of the natural membrane or capsule that holds the artificial lens. It requires additional procedures to correct the problem. Sodium chloride is not usually used during cataract surgery. It will be used to irrigate the capsular bag and remove any residual cells that contribute to the development of PCO. Perfect Capsule will prevent the sodium chloride from touching other parts of the eye. The goal of this study is to determine if irrigation with sodium chloride will lower the incidence of PCO after cataract surgery.


Condition Intervention Phase
Cataract Extraction
 Procedure: Cataract surgery with Perfect Capsule and Sodium Chloride
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Use of Sealed Capsule Irrigation With Sodium Chloride During Pediatric Cataract Surgery and IOL Implantation

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Estimated Enrollment: 20
Study Start Date: July 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bilateral cataract
  • 4 - 18 years of age
  • Informed consent from the parents/legal guardian.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366613

Locations
United States, South Carolina
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Marion E Wilson, MD Medical University of South Carolina
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00366613     History of Changes
Other Study ID Numbers: SEI-06-002
Study First Received: August 17, 2006
Last Updated: October 2, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Cataract
Cataract Extraction

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013