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Trial registered on ANZCTR


Registration number
ACTRN12613000151730
Ethics application status
Approved
Date submitted
4/02/2013
Date registered
8/02/2013
Date last updated
11/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of alcohol delamination and phototherapeutic keratectomy for the treatment of recurrent erosion syndrome.
Scientific title
A comparative clinical trial of alcohol delamination versus phototherapeutic keratectomy for the treatment of recurrent corneal erosions.
Secondary ID [1] 281876 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recurrent corneal erosion syndrome 288261 0
Condition category
Condition code
Eye 288614 288614 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
alcohol delamination (removal of corneal epithelium with 50um of 25% ethyl alcohol for 40 seconds)
Intervention code [1] 286439 0
Treatment: Surgery
Comparator / control treatment
phototherapeutic keratectomy (excimer laser with 9mm treatment zone and depth of 9um). The treatment time including preparation time and epithelial debridement is less than 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 288767 0
pain score using a numerical rating scale
Timepoint [1] 288767 0
24 months
Secondary outcome [1] 300931 0
recurrence of erosions by subjective report
Timepoint [1] 300931 0
24 months
Secondary outcome [2] 300932 0
complications by slit lamp examination (eg. haze, infection, scarring) and measurement of visual acuity
Timepoint [2] 300932 0
24 months

Eligibility
Key inclusion criteria
Individuals with symptomatic recurrent corneal erosion syndrome not responding to conservative treatment including regular topical lubrication and a bandage contact lens
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with a history of previous ocular surgery including any interventional treatment for their recurrent erosion syndrome other than manual epithelial debridement, prior herpetic eye disease, history of other corneal or external eye disease, corneal hypoaesthesia,or a history of diabetes mellitus

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolment via the corneal clinic at the Hospital. Patients will only be randomised following recruitment and completion of the consent. Allocation involved contacting a trial coordinator who held a computer generated randomisation plan.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomized sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 532 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 6272 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 286661 0
Self funded/Unfunded
Name [1] 286661 0
Address [1] 286661 0
Country [1] 286661 0
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] 285439 0
University
Name [1] 285439 0
Centre for Eye Research Australia, University of Melbourne
Address [1] 285439 0
32 Gisborne St, East Melbourne, VIC 3002
Country [1] 285439 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288732 0
The Royal Victorian Eye and Ear Hospital Human Research and Ethics Committee
Ethics committee address [1] 288732 0
32 Gisborne St, East Melbourne, VIC 3002
Ethics committee country [1] 288732 0
Australia
Date submitted for ethics approval [1] 288732 0
Approval date [1] 288732 0
18/12/2006
Ethics approval number [1] 288732 0
06/719H

Summary
Brief summary
To compare two different treatment methods of reducing pain and recurrent episodes in individuals with recurrent corneal erosion syndrome, a syndrome characterised by pain, watering and light sensitivity due to episisodic loosening of the surface cells of the eye. The two methods are laser treatment and alcohol treatment to the surface of the eye. It is hypothesised that the two methods are comparable in their effect.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37534 0
Prof Rasik Vajpayee
Address 37534 0
Royal Victorian Eye and Ear Hospital, 32 Gisborne St, East Melbourne, VIC 3002
Country 37534 0
Australia
Phone 37534 0
+61399298666
Fax 37534 0
Email 37534 0
rasikv@unimelb.edu.au
Contact person for public queries
Name 37535 0
Mr Marios Constantinou
Address 37535 0
Centre for Eye Research Australia
32 Gisborne St, East Melbourne, VIC 3002
Country 37535 0
Australia
Phone 37535 0
+61 3 9929 8360
Fax 37535 0
Email 37535 0
mariosc@unimelb.edu.au
Contact person for scientific queries
Name 37536 0
Mr Marios Constantinou
Address 37536 0
Centre for Eye Research Australia
32 Gisborne St, East Melbourne, VIC 3002
Country 37536 0
Australia
Phone 37536 0
+61 3 9929 8360
Fax 37536 0
Email 37536 0
mariosc@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary