Corneal Wound HealingNCT00915759
Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
A study testing ProKera and Bandage contact lens in people with Corneal Wound Healing, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of ProKera on corneal wound healing after photorefractive keratectomy (PRK) in terms of re-epithelialization, pain, adverse effects, visual recovery, refractive accuracy, and corneal clarity. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Wound Healing
- What is being tested?
- ProKera and Bandage contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active duty US Army Soldiers eligible for care at WRAMC.
- Male or female, of any race, and at least 21 years old at the time of the preoperative examination, and have signed and informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- Subject must expect to be located in the greater Washington, District of Columbia area for a 12 month period post-operatively.
- Consent of the subject's command (active duty) to participate in the study.
- Access to transportation to meet follow-up requirements.
Who cannot join
- Any reason to be excluded for PRK.
- Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be give a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not].
- Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Any physical or mental impairment that would preclude participation in any of the examinations.
- Anterior basement membrane dystrophy.
- History of recurrent epithelial erosion.
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- Significant dry eye (symptomatic with Schirmer test < 5 mm at 5 minutes).
- Other corneal epithelial disorder or healing abnormality.
- Patients with unusually tight eyelids close to the eyeball making it difficult and/ or painful to insert anything (e.g., ProKera) between the eyelid and globe.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
The purpose of this study is to evaluate the effect of ProKera on corneal wound healing after photorefractive keratectomy (PRK) in terms of re-epithelialization, pain, adverse effects, visual recovery, refractive accuracy, and corneal clarity.
- Conditions
- Corneal Wound Healing
- Being tested
- ProKera, Bandage contact lens
- Keywords
- ProKera, Amniotic membrane, Photorefractive Keratectomy, PRK, time to re-epithelialization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProKeraDevice
ProKera placed in non-dominant eye after photorefractive keratectomy (PRK)
Bandage contact lensDevice
Bandage contact lens placed in dominant eye, the current standard after photorefractive keratectomy (PRK)
| Study group | Role | What they receive |
|---|---|---|
| ProKera | Active comparator | Not described Receives: Device: ProKera |
| Bandage contact lens | Placebo comparator | Not described Receives: Device: Bandage contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days to Complete Re-epithelialization
measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy
Measured: participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively
Secondary outcomes (6)
Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain)
measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Measured: Day 1
Number of Eyes With Complications/Adverse Events
Measured: up to one year post-operatively
Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively
Uncorrected Distance Visual Acuity
Measured: one year post-operatively
Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively
Manifest spherical equivalent within +/- 0.50 diopters of emmetropia
Measured: one year post-operatively
Number of Eyes With Clinically Significant Corneal Haze
clinically significant corneal haze (grade 2 or higher)
Measured: one year postoperatively
Tear Total Protein Levels
total protein levels
Measured: 1 month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2010
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal Wound HealingStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- BioTissue Holdings, Inc, St. John's Hospital, University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Richard D Stutzman, MD, Principal investigator, WRNMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915759
- Sponsor's protocol ID
- 08-6961
- Status last verified
- Feb 2025
- First submitted
- 5 Jun 2009
- Last updated
- 7 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
- ClinicalTrials.gov ID
- NCT00915759
- Acronym / sponsor ID
- 08-6961
- Conditions
- Corneal Wound Healing
- Keywords
- ProKera, Amniotic membrane, Photorefractive Keratectomy, PRK, time to re-epithelialization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- BioTissue Holdings, Inc, St. John's Hospital, University of Colorado, Denver
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Posted 20 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of ProKera on corneal wound healing after photorefractive keratectomy (PRK) in terms of re-epithelialization, pain, adverse effects, visual recovery, refractive accuracy, and corneal clarity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProKera | Active comparator | Device: ProKera |
| Bandage contact lens | Placebo comparator | Device: Bandage contact lens |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Active duty US Army Soldiers eligible for care at WRAMC.
- Male or female, of any race, and at least 21 years old at the time of the preoperative examination, and have signed and informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- Subject must expect to be located in the greater Washington, District of Columbia area for a 12 month period post-operatively.
- Consent of the subject's command (active duty) to participate in the study.
- Access to transportation to meet follow-up requirements.
Key exclusion criteria (9 listed)
- Any reason to be excluded for PRK.
- Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be give a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not].
- Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Any physical or mental impairment that would preclude participation in any of the examinations.
- Anterior basement membrane dystrophy.
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 |
|---|---|---|
| ProKeraProKera placed in non-dominant eye after photorefractive keratectomy (PRK) | Device | ProKera |
| Bandage contact lensBandage contact lens placed in dominant eye, the current standard after photorefractive keratectomy (PRK) | Device | Bandage contact lens |
Primary outcome
Number of Days to Complete Re-epithelialization
Time frame: participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively
measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy
6 secondary outcomes
Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain)
Time frame: Day 1
Number of Eyes With Complications/Adverse Events
Time frame: up to one year post-operatively
Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively
Time frame: one year post-operatively
Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively
Time frame: one year post-operatively
Number of Eyes With Clinically Significant Corneal Haze
Time frame: one year postoperatively
Tear Total Protein Levels
Time frame: 1 month post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard D Stutzman, MD principal investigator
WRNMMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProKera and Bandage contact lens in people with Corneal Wound Healing, run by Walter Reed National Military Medical Center 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 5 inclusion and 9 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 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Days to Complete Re-epithelialization (time frame: participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively). 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 Feb 2025.