Trial Outcomes & Findings for Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy (NCT NCT00915759)

Results Overview

measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively

Results posted on

2025-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	ProKera/Bandage Contact Lens Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after photorefractive keratectomy (PRK)
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ProKera and Bandage Contact Lens n=40 Participants Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	30.1 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy

Outcome measures

Outcome measures
Measure	ProKera n=9 Participants Group 1: ProKera in place until complete corneal re-epithelialization (healing)	Bandage Contact Lens n=9 eyes Group 1: bandage contact lens in place until complete corneal re-epithelialization (healing)
Number of Days to Complete Re-epithelialization	4.6 days to complete re-epithelialization Standard Deviation 1.6	4.1 days to complete re-epithelialization Standard Deviation 1.4

PRIMARY outcome

Timeframe: 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.

measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy

Outcome measures

Outcome measures
Measure	ProKera n=15 eyes Group 1: ProKera in place until complete corneal re-epithelialization (healing)	Bandage Contact Lens n=15 eyes Group 1: bandage contact lens in place until complete corneal re-epithelialization (healing)
Number of Days to Complete Re-epithelialization	5.2 days to complete re-epithelialization Standard Deviation 3.5	3.9 days to complete re-epithelialization Standard Deviation 1.1

PRIMARY outcome

Timeframe: 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.

measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy

Outcome measures

Outcome measures
Measure	ProKera n=16 eyes Group 1: ProKera in place until complete corneal re-epithelialization (healing)	Bandage Contact Lens n=16 eyes Group 1: bandage contact lens in place until complete corneal re-epithelialization (healing)
Number of Days to Complete Re-epithelialization	4.0 days to complete re-epithelialization Standard Deviation 0.8	3.8 days to complete re-epithelialization Standard Deviation 0.5

SECONDARY outcome

Timeframe: Day 1

Population: eyes

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

Outcome measures

Outcome measures
Measure	ProKera n=40 eyes Group 1: ProKera in place until complete corneal re-epithelialization (healing)	Bandage Contact Lens n=40 eyes Group 1: bandage contact lens in place until complete corneal re-epithelialization (healing)
Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain)	4.6 VAS score Standard Deviation 3.3	4.8 VAS score Standard Deviation 2.5

SECONDARY outcome

Timeframe: up to one year post-operatively

Population: eyes

Outcome measures

Outcome measures
Measure	ProKera n=40 eye Group 1: ProKera in place until complete corneal re-epithelialization (healing)	Bandage Contact Lens n=40 eye Group 1: bandage contact lens in place until complete corneal re-epithelialization (healing)
Number of Eyes With Complications/Adverse Events Spontaneous extrusion of the graft (or BCL) at first postop week	1 eye	0 eye
Number of Eyes With Complications/Adverse Events Delayed epithelial healing in early postop	1 eye	0 eye
Number of Eyes With Complications/Adverse Events Persistent epithelial defect in early postop	2 eye	0 eye
Number of Eyes With Complications/Adverse Events Corneal infiltrates (inflammatory) in early postop	4 eye	4 eye
Number of Eyes With Complications/Adverse Events non-granulomatous anterior uveitis at 1 week postop	1 eye	0 eye

SECONDARY outcome

Timeframe: one year post-operatively

Population: eyes

Uncorrected Distance Visual Acuity

Outcome measures

Outcome measures
Measure	ProKera n=35 eyes Group 1: ProKera in place until complete corneal re-epithelialization (healing)	Bandage Contact Lens n=35 eyes Group 1: bandage contact lens in place until complete corneal re-epithelialization (healing)
Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively	34 eyes	35 eyes

SECONDARY outcome

Timeframe: one year post-operatively

Population: eyes

Manifest spherical equivalent within +/- 0.50 diopters of emmetropia

Outcome measures

Outcome measures
Measure	ProKera n=35 eyes Group 1: ProKera in place until complete corneal re-epithelialization (healing)	Bandage Contact Lens n=35 eyes Group 1: bandage contact lens in place until complete corneal re-epithelialization (healing)
Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively	32 eyes	30 eyes

SECONDARY outcome

Timeframe: one year postoperatively

clinically significant corneal haze (grade 2 or higher)

Outcome measures

Outcome measures
Measure	ProKera n=35 eyes Group 1: ProKera in place until complete corneal re-epithelialization (healing)	Bandage Contact Lens n=35 eyes Group 1: bandage contact lens in place until complete corneal re-epithelialization (healing)
Number of Eyes With Clinically Significant Corneal Haze	0 eyes	0 eyes

SECONDARY outcome

Timeframe: 1 month post-operatively

Population: samples

total protein levels

Outcome measures

Outcome measures
Measure	ProKera n=16 samples Group 1: ProKera in place until complete corneal re-epithelialization (healing)	Bandage Contact Lens n=13 samples Group 1: bandage contact lens in place until complete corneal re-epithelialization (healing)
Tear Total Protein Levels	9.6 mg/ml Standard Deviation 0.9	9.9 mg/ml Standard Deviation 0.8

Adverse Events

ProKera

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Bandage Contact Lens

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ProKera n=40 participants at risk Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK	Bandage Contact Lens n=40 participants at risk Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
Eye disorders Acute non-granulomatous anterior uveitis	2.5% 1/40 • Number of events 1 • 1 year	0.00% 0/40 • 1 year
Eye disorders Spontaneous extrusion of the graft (or BCL) at first postop week	2.5% 1/40 • Number of events 1 • 1 year	0.00% 0/40 • 1 year
Eye disorders Delayed epithelial healing in early postop	2.5% 1/40 • Number of events 1 • 1 year	0.00% 0/40 • 1 year
Eye disorders Persistent epithelial defect in early postop	5.0% 2/40 • Number of events 2 • 1 year	0.00% 0/40 • 1 year
Eye disorders corneal infiltrates (inflammatory) in early postop	10.0% 4/40 • Number of events 4 • 1 year	10.0% 4/40 • Number of events 4 • 1 year

Additional Information

Principal Investigator

Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir

Phone: 571-231-1600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER