Evaluating the Use of ProKera Plus in the Management of Bacterial Corneal Ulcers
-
- STATUS
- Recruiting
-
- End date
- Nov 20, 2023
-
- participants needed
- 24
-
- sponsor
- University of Arkansas
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.
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:
- To determine if ProKera Plus can lead to better visual recovery when used with bacterial corneal ulcers compared to conventional treatment
- 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
- To determine if ProKera Plus can decrease pain associated with bacterial corneal ulcers compared to conventional treatment
- To determine if ProKera Plus can decrease the amount of corneal opacity and corneal thinning associated with bacterial corneal ulcers compared to conventional treatment
- To determine if ProKera Plus can decrease the need for further interventions or surgeries related to complications from bacterial corneal ulcers
Details
| Condition | Bacterial Corneal Ulcer |
|---|---|
| Treatment | ProProKera Plus® |
| Clinical Study Identifier | NCT04850313 |
| Sponsor | University of Arkansas |
| Last Modified on | 11 December 2021 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer