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

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.
ClinicalTrials.gov Identifier: NCT00366613
Recruitment Status : Withdrawn (We wish to wait until there is more data available using this substance.)
First Posted : August 21, 2006
Last Update Posted : October 3, 2007
Sponsor:
Information provided by:

Study Description
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 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 or disease Intervention/treatment Phase
Cataract Extraction Procedure: Cataract surgery with Perfect Capsule and Sodium Chloride Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Use of Sealed Capsule Irrigation With Sodium Chloride During Pediatric Cataract Surgery and IOL Implantation
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00366613     History of Changes
Other Study ID Numbers: SEI-06-002
First Posted: August 21, 2006    Key Record Dates
Last Update Posted: October 3, 2007
Last Verified: August 2007

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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases