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

This study has been completed.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00570648
First received: December 7, 2007
Last updated: August 6, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Corneal Transplantation
Drug: sodium hyaluronate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Study of the Effect of Topical Sodium Hyaluronate Immediately Post-PKP on Time to Reepithelialization

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Time to graft reepithelialization [ Time Frame: weekly until total reepithelialization occurs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 24 hours post-op and weekly until reepithelialization occurs ] [ Designated as safety issue: No ]
  • safety [ Time Frame: 24 hours then weekly until reepithelialization occurs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: June 2007
Study Completion Date: June 2008
Arms Assigned Interventions
Experimental: 1
1% sodium hyaluronate (Healoon) applied at the end of surgery to the surface of the corneal transplant
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.
Other Name: Healon
No Intervention: 2
Nothing applied at the end of surgery

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570648

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Christopher Ketcherside, MD University of Virginia
  More Information

No publications provided

Responsible Party: Christopher Ketcherside, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT00570648     History of Changes
Other Study ID Numbers: 13114
Study First Received: December 7, 2007
Last Updated: August 6, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Corneal transplantation

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 22, 2014