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Trial registered on ANZCTR


Registration number
ACTRN12616001554459p
Ethics application status
Not yet submitted
Date submitted
7/11/2016
Date registered
10/11/2016
Date last updated
10/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of ProKera (Registered Trademark) in the management of persistent epithelial defects.
Scientific title
Efficacy of ProKera (Registered Trademark) in the management of persistent epithelial defects.
Secondary ID [1] 290473 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
corneal ulcer 300842 0
Condition category
Condition code
Eye 300667 300667 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 296327 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300091 0
Time to epithelial healing as assessed by slit lamp examination and fluorescein staining.
Timepoint [1] 300091 0
Time to epithelial healing (this will be determined by ulcer size assessed at the clinic visits at both 3-4 days and 7-10 days)
Secondary outcome [1] 328998 0
Visual acuity using LogMAR chart and converted to Snellen visual acuity with and without pinhole or glasses
Timepoint [1] 328998 0
3-4 days, 7-10 days and 14 days after application
Secondary outcome [2] 329101 0
complication - corneal perforation as determined by slit lamp examination and fluorescein staining
Timepoint [2] 329101 0
3-4 days, 7-10 days and 14 days
Secondary outcome [3] 329102 0
complication - microbial keratitis as assessed by slit lamp examination
Timepoint [3] 329102 0
3-4 days, 7-10 days and 14 days

Eligibility
Key inclusion criteria
18 years old or older

Persistent epithelial defect > 2 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2017
Actual
Date of last participant enrolment
Anticipated
1/01/2018
Actual
Date of last data collection
Anticipated
1/04/2018
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294889 0
Commercial sector/Industry
Name [1] 294889 0
Designs for Vision (providing the device only)
Country [1] 294889 0
Australia
Primary sponsor type
Hospital
Name
Royal Victorian Eye and Ear Hospital
Address
32 Gisborne St, East Melbourne, VIC 3002
Country
Australia
Secondary sponsor category [1] 293726 0
None
Name [1] 293726 0
None
Address [1] 293726 0
None
Country [1] 293726 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296268 0
Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 296268 0
32 Gisborne St, East Melbourne, VIC 3002
Ethics committee country [1] 296268 0
Australia
Date submitted for ethics approval [1] 296268 0
10/11/2016
Approval date [1] 296268 0
Ethics approval number [1] 296268 0

Summary
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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70202 0
Dr Elsie Chan
Address 70202 0
Royal Victorian Eye and Ear Hospital
32 Gisborne St
East Melbourne, VIC 3002
Country 70202 0
Australia
Phone 70202 0
+61 3 9929 8666
Fax 70202 0
Email 70202 0
[email protected]
Contact person for public queries
Name 70203 0
Elsie Chan
Address 70203 0
Royal Victorian Eye and Ear Hospital
32 Gisborne St
East Melbourne, VIC 3002
Country 70203 0
Australia
Phone 70203 0
+61 3 9929 8666
Fax 70203 0
Email 70203 0
[email protected]
Contact person for scientific queries
Name 70204 0
Elsie Chan
Address 70204 0
Royal Victorian Eye and Ear Hospital
32 Gisborne St
East Melbourne, VIC 3002
Country 70204 0
Australia
Phone 70204 0
+61 3 9929 8666
Fax 70204 0
Email 70204 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.