A Prospective Study of the Effect of Topical Sodium Hyaluronate Immediately Post-PKP on Time to Reepithelialization

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis: 1% sodium hyaluronate (Healon), applied at end of surgery to the surface of a corneal transplant will not shorten graft reepithelialization time when compared to coating with nothing. We also wish to measure and compare visual acuity in this immediate post operative period. We also wish to assess the safety of using this agent on the epithelium post-operatively.

We will recruit 50 high risk patients (see inclusion criteria) here at the University of Virginia to randomly receive nothing or sodium hyaluronate (Healon) on the ocular surface at the end of surgery, and follow time to reepithelialization of the corneal transplant grafts.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

• The patients considered for enrollment must be scheduled for penetrating keratoplasty.

• Any high risk patient requiring penetrating keratoplasty.

Criteria for high risk include one of the following:

• Prior failed corneal graft in the operative eye

• Being treated for dry eye at time of surgery

• Having 2 or more quadrants of corneal vascularization

• Having another procedure performed on same eye at time of PKP

Exclusion Criteria:

• Does not meet one of the criteria for high risk

• Known hypersensitivity to hyaluronate preparations

• Allergic to avian proteins, feathers, or egg products

• Pregnant or breast feeding