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

NCT00570648 | Completed

• 1 other identifier: 13114
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Corneal Transplantation

Keywords

Corneal transplantation

Outcome Measures

Primary Outcomes (1)

• Time to graft reepithelialization

  weekly until total reepithelialization occurs

Secondary Outcomes (2)

• Visual acuity

  24 hours post-op and weekly until reepithelialization occurs

• safety

  24 hours then weekly until reepithelialization occurs

Study Arms (2)

1

EXPERIMENTAL

1% sodium hyaluronate (Healoon) applied at the end of surgery to the surface of the corneal transplant

Drug: sodium hyaluronate

2

NO INTERVENTION

Nothing applied at the end of surgery

Interventions

sodium hyaluronate DRUG

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.

Also known as: Healon

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Christopher Ketcherside, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 11, 2007
• Study Start: June 1, 2007
• Study Completion: June 1, 2008
• Last Updated: August 7, 2008

Record last verified: 2008-08

Locations

US (1)