Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000660189
Ethics application status
Approved
Date submitted
11/02/2019
Date registered
2/05/2019
Date last updated
27/08/2021
Date data sharing statement initially provided
2/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical Dorzolamide for Idiopathic Macular Hole
Scientific title
A randomised clinical trial, to evaluate the efficacy of topical dorzolamide for the treatment of idiopathic macular hole
Secondary ID [1] 297353 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic macular hole 311499 0
Condition category
Condition code
Eye 310134 310134 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this double blinded study, those randomised to treatment will receive 2% dorzolamide drops to the eye three times per day for 8 weeks. Drops will be self administered by the patient following detailed instruction and will not be supervised.
Intervention code [1] 313616 0
Treatment: Drugs
Comparator / control treatment
Placebo, 0.9% saline drops
Control group
Placebo

Outcomes
Primary outcome [1] 319027 0
Closure of macular hole as assessed with optical coherence tomography
Timepoint [1] 319027 0
8 weeks post initiation of treatment.
Secondary outcome [1] 366753 0
Visual acuity measured in letters using an ETDRS chart
Timepoint [1] 366753 0
8 weeks post initiation of treatment.
Secondary outcome [2] 366754 0
Central retinal thickness as assessed with optical coherence tomography
Timepoint [2] 366754 0
8 weeks post initiation of treatment.

Eligibility
Key inclusion criteria
Ability to provide informed consent and complete study assessments
Age 18 years or older
Idiopathic macular hole in study eye
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Renal impairment with creatinine clearance <30ml/min.
Other retinal pathology

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)
Allocation concealment using identical appearing numbered dropper bottles
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number needed to detect a difference of 50% magnitude in difference in hole closure is 13 subjects in each arm (power of 80% and confidence interval of 95%). Assuming a rate of non-closure in observation group to be 6% and rate of non-closure in CAI treated group to be 50%, the number needed to treat would be 2.3 patients.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/05/2019
Actual
28/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 13088 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 25597 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 301918 0
Hospital
Name [1] 301918 0
Royal Adelaide Hospital
Country [1] 301918 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Institute of Ophthalmology
Address
6G Ophthalmology
The Royal Adelaide Hospital
1 Port Rd, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 301673 0
None
Name [1] 301673 0
Address [1] 301673 0
Country [1] 301673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302603 0
CALHN Human Research Ethics Committee
Ethics committee address [1] 302603 0
CALHN Research Office
RAH Clinical Trial Centre
Wayfinder 3D460.02
Level 3, Royal Adelaide Hospital
Port Road
ADELAIDE SA 5000
Ethics committee country [1] 302603 0
Australia
Date submitted for ethics approval [1] 302603 0
17/04/2019
Approval date [1] 302603 0
06/05/2019
Ethics approval number [1] 302603 0
R20190214

Summary
Brief summary
This randomised controlled trial will assess the efficacy of topical dorzolamide achieving macular hole closure prior to vitreoretinal surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90790 0
Dr Weng Onn Chan
Address 90790 0
6G Ophthalmology
The Royal Adelaide Hospital
1 Port Rd, Adelaide SA 5000
Country 90790 0
Australia
Phone 90790 0
+61 8 70740000
Fax 90790 0
Email 90790 0
[email protected]
Contact person for public queries
Name 90791 0
Dr Weng Onn Chan
Address 90791 0
6G Ophthalmology
The Royal Adelaide Hospital
1 Port Rd, Adelaide SA 5000
Country 90791 0
Australia
Phone 90791 0
+61 8 70740000
Fax 90791 0
Email 90791 0
[email protected]
Contact person for scientific queries
Name 90792 0
Dr Weng Onn Chan
Address 90792 0
6G Ophthalmology
The Royal Adelaide Hospital
1 Port Rd, Adelaide SA 5000
Country 90792 0
Australia
Phone 90792 0
+61 8 70740000
Fax 90792 0
Email 90792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This data will not be disclosed as per the ethics applicition.


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.