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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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.

Detailed Summary:

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 years of age. Despite advances in cataract surgery in children, PCO remained a significant complication following pediatric cataract surgery. In addition to being visually disturbing, it also induces amblyopia in children and if not treated at earliest, irreversible visual changes may occur. The younger the child, more acute is the problem: PCO occurs faster and effect of amblyopia is more pronounced. PCO generally requires second surgical intervention, as closure of the opening made by YAG capsulotomy is very common after pediatric cataract surgery. Many times, children are not cooperative to sit down for YAG capsulotomy, and that may also be an additional indication for second surgery for PCO.

Removal of residual epithelial cells is one of the key factors to avoid the complication of PCO. Several chemicals have been suggested in experimental settings to remove or kill these residual lens epithelial cells. However, they are toxic to other ocular structures. Researchers are searching for a device which can help to selectively kill these lens epithelial cells. In the long term, this may help to avoid PCO.

Perfect Capsule: Perfect CapsuleTM (Milvella ltd) is a sterile single use ophthalmic instrument used to perform sealed irrigation of the capsular bag during cataract surgery in order to facilitate irrigation of the capsule without the irrigation fluid contacting other ocular structures. The device has the FDA approval via 510(k) in the USA, and is CE marked in Europe. No specific age limit has been listed for FDA approval. The device (see fig) consists of a 7 mm diameter head, a 3 mm wide body and a 4 mm wide foot that remain
Sponsor: Medical University of South Carolina

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Information By: Medical University of South Carolina

Dates:
Date Received: August 17, 2006
Date Started: July 2005
Date Completion:
Last Updated: October 2, 2007
Last Verified: August 2007