A Prospective Study of the Effect of Topical Sodium Hyaluronate Immediately Post-PKP on Time to Reepithelialization
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|ClinicalTrials.gov Identifier: NCT00570648|
Recruitment Status : Completed
First Posted : December 11, 2007
Last Update Posted : August 7, 2008
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 or disease||Intervention/treatment||Phase|
|Corneal Transplantation||Drug: sodium hyaluronate||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Prospective Study of the Effect of Topical Sodium Hyaluronate Immediately Post-PKP on Time to Reepithelialization|
|Study Start Date :||June 2007|
|Actual Study Completion Date :||June 2008|
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
- Time to graft reepithelialization [ Time Frame: weekly until total reepithelialization occurs ]
- Visual acuity [ Time Frame: 24 hours post-op and weekly until reepithelialization occurs ]
- safety [ Time Frame: 24 hours then weekly until reepithelialization occurs ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570648
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Christopher Ketcherside, MD||University of Virginia|