Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000275864
Ethics application status
Approved
Date submitted
3/03/2012
Date registered
8/03/2012
Date last updated
29/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy of diamond burr superficial keratectomy in the treatment of recurrent corneal erosions
Scientific title
Evaluating the Efficacy of Diamond Burr Superficial Keratectomy Patients with Recurrent Erosion Syndrome.
Secondary ID [1] 280071 0
Nil
Universal Trial Number (UTN)
U1111-1128-8837
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent corneal erosions 285979 0
Condition category
Condition code
Eye 286169 286169 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diamond Burr Superficial Keratectomy - using a diamond burr to polish the area around the corneal erosion no deeper then Bowman's layer. This roughens the area allowing better attachment of epithelial cells over the eroded area. The procedure takes approximately 30 minutes.
Intervention code [1] 284392 0
Treatment: Surgery
Comparator / control treatment
Nil comparator as this is a retrospective trial looking at the number of recurrences following Diamond Burr Superficial Keratectomy via chart reviews of patients that have undergone the procedure. Historical records will be used. Charts from an Ophthalmology practice will be the source and the data will be from the year 2000 to present.
Control group
Historical

Outcomes
Primary outcome [1] 286637 0
Decrease in the incidence of corneal erosions.

Corneal erosions are extremely painful and the patients that have undergone treatment have had several episodes. Therefore patients will self-report re-occurence at either a follow up appointment or via a telephone interview. The telephone interview is required for patients that have not been seen 6 months post treatment. The primary outcome will be whether the corneal erosion returned or was successfully treated.
Timepoint [1] 286637 0
6 months
Secondary outcome [1] 296342 0
Nil
Timepoint [1] 296342 0
Nil

Eligibility
Key inclusion criteria
Diagnosis of Recurrent Erosion Syndrome by an ophthalmologist with a slit lamp microscope.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284823 0
Self funded/Unfunded
Name [1] 284823 0
Country [1] 284823 0
Primary sponsor type
Individual
Name
Dr Geoffrey Ryan
Address
60 Upper Cairns Terrace
Red Hill, QLD
4059
Country
Australia
Secondary sponsor category [1] 283704 0
Individual
Name [1] 283704 0
Dr Graham Lee
Address [1] 283704 0
City Eye Centre
Level 10
135 Wickham Terrace
Brisbane QLD 4000
Country [1] 283704 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286814 0
Queensland Eye Institute
Ethics committee address [1] 286814 0
PO BOX 8249, Woolloongabba, QLD 4102
Ethics committee country [1] 286814 0
Australia
Date submitted for ethics approval [1] 286814 0
15/03/2012
Approval date [1] 286814 0
Ethics approval number [1] 286814 0
201201

Summary
Brief summary
This study will look at patients diagnosed with recurrent erosion syndrome which is a problem where people affected have repeated episodes of abrasions of the cornea (clear portion of the front of the eye). It will examine the incidence of episodes of erosions following treatment with Diamond Burr Superficial Keratectomy (DBSK). This study will use information from each patient’s medical chart and ask each participant to answer a very quick questionnaire via telephone interview. The results compiled will help decide whether this treatment should be offered to more patients in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33862 0
Address 33862 0
Country 33862 0
Phone 33862 0
Fax 33862 0
Email 33862 0
Contact person for public queries
Name 17109 0
Geoffrey Ryan
Address 17109 0
60 Upper Cairns Terrace
Red Hill, QLD
4059
Country 17109 0
Australia
Phone 17109 0
+61732175307
Fax 17109 0
Email 17109 0
[email protected]
Contact person for scientific queries
Name 8037 0
Geoffrey Ryan
Address 8037 0
60 Upper Cairns Terrace
Red Hill, QLD
4059
Country 8037 0
Australia
Phone 8037 0
+61732175307
Fax 8037 0
Email 8037 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.