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

Corneal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570648
• Other study ID #: 13114
• Status: Completed
• Phase: N/A
• First received: December 7, 2007
• Last updated: August 6, 2008
• Start date: June 2007
• Est. completion date: June 2008

Study information

• Verified date: August 2008
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Corneal transplant is one of the most common transplant procedures, with over 32,000 recipients in the United States in 2005 and a similar number estimated in 2006. The immediate post-operative period is very important in determining the quality of the graft and often its overall chance of survival. The corneal epithelium is replaced by the recipient epithelium after transplant and this should usually take place in no more than 1 week. This reepithelialization is very important for healing, recovery of the epithelial barrier against infectious agents, and for recovery of vision through the graft. Grafts that take longer to heal can invite not only infection and hinder visual recovery, but be permanently scarred, thinned, and even perforate/fail. Thus rapid reepithelialization is crucial. This becomes even more crucial for monocular patients who need quick recovery.

Currently there is no universal agent that is used to coat the surface at the end of surgery before patching. Previous animal studies have shown that sodium hyaluronate will promote rapid migration of cells as well as stimulate cell proliferation leading to rapid wound closure (1,2). In 1987 one smaller study showed that topical sodium hyaluronate (Healon) may foster improved epithelial healing but it was used intraoperatively and presented technical challenges (3). A more recent non-randomized, retrospective study found that sodium hyaluronate at the end of surgery to coat the ocular surface shortened reepithelialization time. This was in comparison to dexamethasone/oxytetracycline ointment and neomycin/dexamethasone drops, both of which hinder reepithelialization (4). To date we know of no prospective, randomized, double-blinded studies that compare the application of sodium hyaluronate versus nothing (currently the practice at UVA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Transplantation

Intervention

Drug:
• sodium hyaluronate
1% sodium hyaluronate applied at the end of corneal transplant surgery. The amount will be determined on how much is necessary to cover the ocular surface.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to graft reepithelialization		weekly until total reepithelialization occurs	No
Secondary	Visual acuity		24 hours post-op and weekly until reepithelialization occurs	No
Secondary	safety		24 hours then weekly until reepithelialization occurs	Yes