Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000014055
Ethics application status
Approved
Date submitted
7/12/2009
Date registered
7/01/2010
Date last updated
7/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Amniotic membrane extract eye drops for eye surface diseases.
Scientific title
The effect of amniotic membrane extract eye drops on promoting epithelialization and suppressing inflammation in patients with ocular surface diseases.
Secondary ID [1] 1215 0
nil
Universal Trial Number (UTN)
U1111-1112-7631
Trial acronym
AME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The efficacy of amniotic membrane extract in the treatment of ocular surface diseases with inflammation and epithelial disorders. 252350 0
Condition category
Condition code
Eye 252539 252539 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Amniotic membrane extract (AME) eye drops are made from amniotic membrane which has been widely used as a patch or graft for ocular surface diseases.
AME is applied one drop (0.1ml) every hour for the first week, then every two hours untill complete epithelialization, then 4 times a day untill inflammation subsides.
The patients enrolled might have prior failed amniotic membrane transplantation (AMT).
Intervention code [1] 255661 0
Treatment: Other
Comparator / control treatment
Arm 1: AME in combination with treatments for underlying diseases;
Arm 2: AMT in combination with treatments for underlying diseases;
Arm 3: Artificial tears in combination with treatments for underlying diseases.
For AMT, amniotic membrane is secured onto the ocular surface with or without sutures. The procedure requires approximately 30 to 60 minutes.
Control group
Active

Outcomes
Primary outcome [1] 257493 0
mean epithelialization time, the epithelialization is measured by fluorescein stainning under slit lamp examination
Timepoint [1] 257493 0
every other day during first week, then 2, 3 weeks, 1, 2, 3, 6, 12 months following treatment.
Secondary outcome [1] 262533 0
mean inflammation score
Timepoint [1] 262533 0
1, 2, 3 weeks, 1, 2, 3, 6, 12 months following treatment.

Eligibility
Key inclusion criteria
ocular surface diseases with epithelial disorders and inflammation
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
trichiasis, palpebral conjunctiva scar, limbal stem cell dificiency, corneal perforation

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
Completed
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2353 0
China
State/province [1] 2353 0

Funding & Sponsors
Funding source category [1] 256140 0
Other
Name [1] 256140 0
Scientific and Technological Committee of Guangdong Province, China (2006B36006002)
Country [1] 256140 0
China
Primary sponsor type
Individual
Name
Zuguo Liu
Address
54S Xianlie Road, Guangzhou, GD, 510060
Country
China
Secondary sponsor category [1] 251481 0
Hospital
Name [1] 251481 0
Zhongshan Ophthalmic Center
Address [1] 251481 0
54S Xianlie Road
Guangzhou 510060
Country [1] 251481 0
China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30588 0
Address 30588 0
Country 30588 0
Phone 30588 0
Fax 30588 0
Email 30588 0
Contact person for public queries
Name 13835 0
Lingyi Liang
Address 13835 0
54S Xianlie Road
Guangzhou, GD
510060
Country 13835 0
China
Phone 13835 0
+86 13829738319
Fax 13835 0
Email 13835 0
[email protected]
Contact person for scientific queries
Name 4763 0
Zuguo Liu
Address 4763 0
54S Xianlie Road
Guangzhou, GD
510060
Country 4763 0
China
Phone 4763 0
+86 592 2186 901
Fax 4763 0
Email 4763 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.