Evaluating the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers

Not Applicable

Terminated

Conditions: Bacterial Corneal Ulcer

Interventions: Device: ProProKera Plus®

Registration Number: NCT04850313

Lead Sponsor: University of Arkansas

Brief Summary: The study design is a prospective, randomized, controlled interventional study to compare the outcome of ProKera Plus® with conventional treatment in patients with vision-threatening bacterial corneal ulcers. The study will be conducted at the University of Arkansas Medical Sciences (UAMS) in two phases for patients who present to an Ophthalmology clinic or Emergency Department at UAMS.

Detailed Description: Bacterial keratitis is a serious bacterial infection of the cornea, usually caused by a persistent epithelial defect or ulcer that can lead to permanent vision loss from corneal scarring, perforation or endophthalmitis. An infectious corneal ulcer requires immediate treatment with intensive topical fortified broad-spectrum antibiotics to try to eliminate the pathogen. Corneal tissue destruction can be caused directly by infectious agents, the associated inflammatory response, or by ocular toxicity from frequent dosing of fortified antibiotics.1 Sutured amniotic membrane transplantation (AMT) has been shown to reduce pain and promote healing in human bacterial keratitis.2 ProKera® is a sutureless form of CryoTek amniotic membrane that is clipped into a dual polycarbonate ring system with the epithelial side up when in contact with the ocular surface. ProKera Plus® contains a double layer of CryoTek amniotic membrane tissue to provide extra therapeutic benefit. ProKera Plus® has several advantages over sutured AMT including ease of administration in a clinic setting and reduced overall procedural cost.

The role of ProKera® in the treatment algorithm of corneal ulcers has yet to be fully clarified. There are currently no prospective case studies comparing the use of ProKera® to standard of care conventional treatments in corneal ulcers. The utility of this device would provide valuable information in the treatment of bacterial corneal ulcers.

The objectives are:

1. To determine if ProKera Plus® can lead to better visual recovery when used with bacterial corneal ulcers compared to conventional treatment

2. To determine if ProKera Plus® can actively modify corneal wound healing during the course of managing bacterial corneal ulcers and decrease the overall time to re-epithelialization

3. To determine if ProKera Plus® can decrease pain associated with bacterial corneal ulcers compared to conventional treatment

4. To determine if ProKera Plus® can decrease the amount of corneal opacity and corneal thinning associated with bacterial corneal ulcers compared to conventional treatment

5. To determine if ProKera Plus® can decrease the need for further interventions or surgeries related to complications from bacterial corneal ulcers

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

Inclusion Criteria

Inclusion Criteria
- Subjects 18 years of age or older, all sexes and races
- Willing to sign a written informed consent to participate
- Corneal ulcer criteria: at least 3mm in diameter, opacification located within 3mm of visual axis, infiltrate occupying at least 50% of the corneal thickness, moderate AC cell reaction, clinical picture consistent with bacterial infection later confirmed by culture and gram stain.

Exclusion Criteria

History of Immunodeficiency
History of connective tissue disorders or severe atopic disease
History of chemical eye injuries
History of known limbal stem cell deficiency
History of neurotrophic keratopathy
History of recent eye surgery, or glaucoma surgery with bleb or drainage tube
Risk factors and clinical appearance consistent with fungal keratitis

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProKera Plus® Treatment	ProProKera Plus®	1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer

Primary Outcome Measures

Name	Time	Method
Visual Acuity - Visit 1	5-day Follow-Up, plus or minus 3 days	Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Visual Recovery - Visit 2	16-day follow-up plus or minus 5 days	Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Visual Recovery - Visit 3	30-day follow-up plus or minus 7 days	Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Visual Recovery - Visit 4	90 day follow-up plus or minus 10 days	Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Visual Recovery - Visit 5	180-day follow-up plus or minus 14 days	Visual acuity (VA) was assessed for participants applicable study eye using a Snellen letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.

Secondary Outcome Measures

Name	Time	Method
Corneal Re-epithelialization - Visit 1	5-day follow-up plus or minus 3 days	number of participants who had slit lamp photography which measured fluorescein staining size.
Eye Pain- Visit 4	90-day follow-up plus or minus 10 days	Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Corneal Re-epithelialization - Visit 2	16-day follow-up plus or minus 5 days	number of participants who had slit lamp photography which measured fluorescein staining size.
Corneal Re-epithelialization - Visit 3	30-day follow-up plus or minus 7 days	number of participants who had slit lamp photography which measured fluorescein staining size.
Corneal Re-epithelialization - Visit 4	90-day follow-up plus or minus 10 days	number of participants who had slit lamp photography which measured fluorescein staining size.
Corneal Opacity Size - Visit 1	5-day follow-up plus or minus 3 days	number of participants who had anterior segment optical coherence tomography (ASOCT).
Corneal Opacity Size - Visit 3	30-day follow-up plus or minus 7 days	number of participants who had anterior segment optical coherence tomography (ASOCT).
Corneal Opacity Thinning-Visit 1	5-day follow-up plus or minus 3 days	number of participants who had anterior segment optical coherence tomography (ASOCT).
Corneal Opacity Thinning-Visit 3	30-day follow-up plus or minus 7 days	number of participants who had anterior segment optical coherence tomography (ASOCT).
Eye Pain- Visit 1	5-day follow-up plus or minus 3 days	Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Eye Pain- Visit 2	16-day follow-up plus or minus 5 days	Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Eye Pain- Visit 3	30-day follow-up plus or minus 7 days	Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Eye Pain- Visit 5	180-day follow-up plus or minus 14 days	Average pain rating across participants which was assessed subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)