None listed
Conditions
Brief summary
The aim of this project is to assess the effectiveness of ProKera (registered trademark) in the treatment of corneal ulcers. The current treatment for non-healing corneal ulcers include lubricating eye drops/ointments, extended wear contact lenses, tarsorrhaphy and botulinum-induced ptosis. Amniotic membrane has also been shown to promote the healing of the corneal surface. However, it is not commercially available in Australia. This project will assess ProKera (registered trademark), which is a commercially available amniotic membrane. It is currently approved by the US Food and Drug Administration but not the Australian Therapeutic Goods Administration. Patients above the age of 18 who are attending the cornea clinic with severe chemical injuries or poorly healing corneal ulcers will be invited to participate. Information to be collected include ulcer size and time to healing, and any complications from using ProKera (registered trademark).
Interventions
Use of ProKera (investigational device). ProKera is a self retaining biological corneal bandage, comprised of a cryopreserved amniotic membrane fastened to an ophthalmic conformer.
It will be applied to participants in the cornea clinic by an experienced ophthalmologist or fellow. The participant will then attend clinic 3-4 days later, and then after 7-10 days.. Once the amniotic membrane has dissolved (usually between 3-10 days), the outer ProKera conformer/ring will be removed during a clinic
Use of ProKera (investigational device). ProKera is a self retaining biological corneal bandage, comprised of a cryopreserved amniotic membrane fastened to an ophthalmic conformer. It will be applied to participants in the cornea clinic by an experienced ophthalmologist or fellow. The participant will then attend clinic 3-4 days later, and then after 7-10 days.. Once the amniotic membrane has dissolved (usually between 3-10 days), the outer ProKera conformer/ring will be removed during a clinic appointment. It is a once only intervention.
Sponsors
Royal Victorian Eye and Ear Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years old or older Persistent epithelial defect > 2 weeks
Exclusion criteria
Patients who are not able to provide informed consent Presence of active microbial keratitis Pregnant or nursing mothers Patients unable to attend follow-up at the clinic Patients with glaucoma drainage devices or filtering blebs Patients with known allergies to ciprofloxacin or amphotericin B Exposure keratopathy
Outcome results
None listed