Corneal Wound Healing
Conditions
Keywords
ProKera, Amniotic membrane, Photorefractive Keratectomy, PRK, time to re-epithelialization
Brief 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.
Interventions
DEVICEProKera
ProKera placed in non-dominant eye after photorefractive keratectomy (PRK)
DEVICEBandage contact lens
Bandage contact lens placed in dominant eye, the current standard after photorefractive keratectomy (PRK)
Sponsors
BioTissue Holdings, Inc
St. John's Hospital
University of Colorado, Denver
Walter Reed National Military Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days to Complete Re-epithelialization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Complications/Adverse Events | up to one year post-operatively | — |
| Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively | one year post-operatively | Uncorrected Distance Visual Acuity |
| Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain) | Day 1 | measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) |
| Number of Eyes With Clinically Significant Corneal Haze | one year postoperatively | clinically significant corneal haze (grade 2 or higher) |
| Tear Total Protein Levels | 1 month post-operatively | total protein levels |
| Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively | one year post-operatively | Manifest spherical equivalent within +/- 0.50 diopters of emmetropia |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ProKera and Bandage Contact Lens Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | ProKera and Bandage Contact Lens |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 30.1 years STANDARD_DEVIATION 6.8 |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 9 / 40 | 4 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
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
Time frame: participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively
Population: Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 2, ProKera and bandage contact lens were left in place until postoperative day 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ProKera | Number of Days to Complete Re-epithelialization | 5.2 days to complete re-epithelialization | Standard Deviation 3.5 |
| Bandage Contact Lens | Number of Days to Complete Re-epithelialization | 3.9 days to complete re-epithelialization | Standard Deviation 1.1 |
Primary
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
Time frame: participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively
Population: Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 3, ProKera and bandage contact lens were left in place until postoperative day 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ProKera | Number of Days to Complete Re-epithelialization | 4.0 days to complete re-epithelialization | Standard Deviation 0.8 |
| Bandage Contact Lens | Number of Days to Complete Re-epithelialization | 3.8 days to complete re-epithelialization | Standard Deviation 0.5 |
Primary
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
Time frame: participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively
Population: Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK. For group 1, ProKera and bandage contact lens were left in place until complete corneal re-epithelialization (healing).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ProKera | Number of Days to Complete Re-epithelialization | 4.6 days to complete re-epithelialization | Standard Deviation 1.6 |
| Bandage Contact Lens | Number of Days to Complete Re-epithelialization | 4.1 days to complete re-epithelialization | Standard Deviation 1.4 |
Secondary
Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively
Uncorrected Distance Visual Acuity
Time frame: one year post-operatively
Population: eyes
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| ProKera | Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively | 34 eyes |
| Bandage Contact Lens | Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively | 35 eyes |
Secondary
Number of Eyes With Clinically Significant Corneal Haze
clinically significant corneal haze (grade 2 or higher)
Time frame: one year postoperatively
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| ProKera | Number of Eyes With Clinically Significant Corneal Haze | 0 eyes |
| Bandage Contact Lens | Number of Eyes With Clinically Significant Corneal Haze | 0 eyes |
Secondary
Number of Eyes With Complications/Adverse Events
Time frame: up to one year post-operatively
Population: eyes
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ProKera | Number of Eyes With Complications/Adverse Events | Spontaneous extrusion of the graft (or BCL) at first postop week | 1 eye |
| ProKera | Number of Eyes With Complications/Adverse Events | Delayed epithelial healing in early postop | 1 eye |
| ProKera | Number of Eyes With Complications/Adverse Events | Persistent epithelial defect in early postop | 2 eye |
| ProKera | Number of Eyes With Complications/Adverse Events | non-granulomatous anterior uveitis at 1 week postop | 1 eye |
| ProKera | Number of Eyes With Complications/Adverse Events | Corneal infiltrates (inflammatory) in early postop | 4 eye |
| Bandage Contact Lens | Number of Eyes With Complications/Adverse Events | Corneal infiltrates (inflammatory) in early postop | 4 eye |
| Bandage Contact Lens | Number of Eyes With Complications/Adverse Events | Spontaneous extrusion of the graft (or BCL) at first postop week | 0 eye |
| Bandage Contact Lens | Number of Eyes With Complications/Adverse Events | Delayed epithelial healing in early postop | 0 eye |
| Bandage Contact Lens | Number of Eyes With Complications/Adverse Events | non-granulomatous anterior uveitis at 1 week postop | 0 eye |
| Bandage Contact Lens | Number of Eyes With Complications/Adverse Events | Persistent epithelial defect in early postop | 0 eye |
Secondary
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
Time frame: one year post-operatively
Population: eyes
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| ProKera | Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively | 32 eyes |
| Bandage Contact Lens | Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively | 30 eyes |
Secondary
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)
Time frame: Day 1
Population: eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ProKera | Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain) | 4.6 VAS score | Standard Deviation 3.3 |
| Bandage Contact Lens | Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain) | 4.8 VAS score | Standard Deviation 2.5 |
Secondary
Tear Total Protein Levels
total protein levels
Time frame: 1 month post-operatively
Population: samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ProKera | Tear Total Protein Levels | 9.6 mg/ml | Standard Deviation 0.9 |
| Bandage Contact Lens | Tear Total Protein Levels | 9.9 mg/ml | Standard Deviation 0.8 |