Corneal TransplantationNCT00570648
A Prospective Study of the Effect of Topical Sodium Hyaluronate Immediately Post-PKP on Time to Reepithelialization
A study testing sodium hyaluronate in people with Corneal Transplantation, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Transplantation
- What is being tested?
- sodium hyaluronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
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.
Read the 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).
- Conditions
- Corneal Transplantation
- Being tested
- sodium hyaluronate
- Keywords
- Corneal transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium hyaluronateDrug
Also called Healon
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1% sodium hyaluronate (Healoon) applied at the end of surgery to the surface of the corneal transplant Receives: Drug: sodium hyaluronate |
| 2 | No intervention | Nothing applied at the end of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to graft reepithelialization
Measured: weekly until total reepithelialization occurs
Secondary outcomes (2)
Visual acuity
Measured: 24 hours post-op and weekly until reepithelialization occurs
safety
Measured: 24 hours then weekly until reepithelialization occurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startJun 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal TransplantationStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Christopher Ketcherside, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570648
- Sponsor's protocol ID
- 13114
- Status last verified
- Aug 2008
- First submitted
- 7 Dec 2007
- Last updated
- 7 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Effect of Topical Sodium Hyaluronate Immediately Post-PKP on Time to Reepithelialization
- ClinicalTrials.gov ID
- NCT00570648
- Acronym / sponsor ID
- 13114
- Conditions
- Corneal Transplantation
- Keywords
- Corneal transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Jun 2008 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: sodium hyaluronate1% sodium hyaluronate (Healoon) applied at the end of surgery to the surface of the corneal transplant |
| 2 | No intervention | –Nothing applied at the end of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patients considered for enrollment must be scheduled for penetrating keratoplasty.
- Any high risk patient requiring penetrating keratoplasty.
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium hyaluronateAlso: Healon1% 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. | Drug | 1 |
Primary outcome
Time to graft reepithelialization
Time frame: weekly until total reepithelialization occurs
2 secondary outcomes
Visual acuity
Time frame: 24 hours post-op and weekly until reepithelialization occurs
safety
Time frame: 24 hours then weekly until reepithelialization occurs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Ketcherside, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium hyaluronate in people with Corneal Transplantation, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to graft reepithelialization (time frame: weekly until total reepithelialization occurs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2008.