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

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 remains external to the eye. The head of the device comprises a circumferential vacuum channel connected to a vacuum syringe via a vacuum tube. The central portion of the head forms a plug with an irrigation/aspiration (I/A) channel (the body) which extend through the cornea allowing fluids to be injected into the under surface of the plug and thus into the capsule. The device has an internal diameter of 5 mm, is molded in medical grade silicone, packaged and gamma sterilized. It can be easily rolled or folded to pass through the standard corneal incision into the eye and positioned on the anterior surface of the capsule using standard ophthalmic instrument.

Concentrated Sodium Chloride: Concentrated Sodium Chloride injection, USP 23.4% (American Regent Laboratories, Inc., Shirley, NY) is sterile, preservative free, nonpyrogenic solution of Sodium Chloride in water for injection. Deionised water has been shown to lyse lens epithelial cells through osmotic flow. Concentrated Sodium Chloride is not currently indicated for intraocular use and is also expected to affect the corneal endothelium. Use of Perfect Capsule will help to avoid the contact of Concentrated sodium Chloride to the endothelial cells.

For the purpose of this study, Concentrated Sodium Chloride for injection will be colored with minimal fluorescein so that the flow and location of it can be visualized throughout the procedure. Viscoelastic within the anterior chamber will provide additional protection for the corneal endothelium.