Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy

• Sponsor: Walter Reed National Military Medical Center (U.S. Fed)
• Overall Status: Unknown status
• CT.gov ID: NCT00915759
• Collaborator: Tissue Tech Inc. (Industry), Department of Ophthalmology and Optometry St John's Hospital and Clinics (Other), Proteomics Shared Resource (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 66
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Wound Healing	Device: ProKera; Device: Bandage contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Nov 1, 2010
• Anticipated Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ProKera	Device: ProKera; ProKera placed in non-dominant eye after PRK
Placebo Comparator: Bandage contact lens	Device: Bandage contact lens; Bandage contact lens placed in dominant eye, the current standard after PRK

Outcome Measures

Primary Outcome Measures

1. Corneal 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 Outcome Measures

1. Post-operative Pain [measured daily until complete re-epithelialization, an expected average of 3-5 days post-operatively]

   measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)

2. Complications/Adverse Events [one year post-operatively]

3. Visual Recovery [one year post-operatively]

4. Long-term Visual Outcomes [one year post-operatively]

5. Corneal Clarity [one year postoperatively]

6. Tear Protein Analysis [up to 1 month post-operatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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 DC 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307

Sponsors and Collaborators

• Walter Reed National Military Medical Center
• Tissue Tech Inc.
• Department of Ophthalmology and Optometry St John's Hospital and Clinics
• Proteomics Shared Resource

Investigators

• Principal Investigator: Richard D Stutzman, MD, WRNMMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samanta B. Rodgers, Assistant Research Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir, Fort Belvoir Community Hospital
• ClinicalTrials.gov Identifier: NCT00915759
• Other Study ID Numbers: 08-6961
• First Posted: Jun 8, 2009
• Last Update Posted: Jul 25, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Samanta B. Rodgers, Assistant Research Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir, Fort Belvoir Community Hospital: ProKera; Amniotic membrane; Photorefractive Keratectomy; PRK; time to re-epithelialization
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	ProKera/Bandage Contact Lens
Arm/Group Description	Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
Period Title: Overall Study
STARTED	40
COMPLETED	40
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	ProKera and Bandage Contact Lens
Arm/Group Description	Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
Overall Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	40 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.1 (6.8)
Sex: Female, Male (Count of Participants)
Female	7 17.5%
Male	33 82.5%
Region of Enrollment (participants) [Number]
United States	40 100%

Outcome Measures

1. Primary Outcome

Title	Corneal Re-epithelialization
Description	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

Outcome Measure Data

Analysis Population Description

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-repithelialization (healing).

Arm/Group Title	ProKera	Bandage Contact Lens
Arm/Group Description	Group 1: ProKera in place until complete corneal re-repithelialization (healing)	Group 1: bandage contact lens in place until complete corneal re-repithelialization (healing)
Measure Participants	9	9
Measure eyes	9	9
Mean (Standard Deviation) [days to complete re-epithelialization]	4.6 (1.6)	4.1 (1.4)

2. Secondary Outcome

Title	Post-operative Pain
Description	measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Time Frame	measured daily until complete re-epithelialization, an expected average of 3-5 days post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Complications/Adverse Events
Time Frame	one year post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Visual Recovery
Time Frame	one year post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Long-term Visual Outcomes
Time Frame	one year post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Corneal Clarity
Time Frame	one year postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Tear Protein Analysis
Time Frame	up to 1 month post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Primary Outcome

Title	Corneal Re-epithelialization
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	ProKera	Bandage Contact Lens
Arm/Group Description	Group 2: ProKera in place until postoperative day 3	Group 2: bandage contact lens in place until postoperative day 3
Measure Participants	15	15
Measure eyes	15	15
Mean (Standard Deviation) [days to complete re-epithelialization]	5.2 (3.5)	3.9 (1.1)

9. Primary Outcome

Title	Corneal Re-epithelialization
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	ProKera	Bandage Contact Lens
Arm/Group Description	Group 3: ProKera in place until postoperative day 1	Group 3: bandage contact lens in place until postoperative day 1
Measure Participants	16	16
Measure eyes	16	16
Mean (Standard Deviation) [days to complete re-epithelialization]	4.0 (0.8)	3.8 (0.5)

Adverse Events

Arm/Group Title	ProKera		Bandage Contact Lens
Arm/Group Description	Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK		Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
All Cause Mortality
	ProKera		Bandage Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ProKera		Bandage Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	ProKera		Bandage Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/40 (2.5%)		0/40 (0%)
Eye disorders
Acute non-granulomatous anterior uveitis	1/40 (2.5%)	1	0/40 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.