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

Withdrawn before enrolling · Phase 4

Conditions studied: Cataract Extraction

In brief

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.

Key facts

Study ID

NCT00366613

Run by

Medical University of South Carolina

People needed

0

Starts

2005-07-01

Expected to finish

2007-08-01

Last updated by the study team

2018-07-23

Who can join

Age: 4 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Storm Eye Institute, Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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