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Trial registered on ANZCTR
Registration number
ACTRN12622000737730p
Ethics application status
Submitted, not yet approved
Date submitted
30/03/2022
Date registered
23/05/2022
Date last updated
23/05/2022
Date data sharing statement initially provided
23/05/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Examining the effect of superior vs temporal laser peripheral iridotomy in adults with primary angle-closure glaucoma or angle-closure suspect
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Scientific title
Dysphotopsia following superior versus temporal laser peripheral iridotomy for treating eyes with narrow anterior chamber angle
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Secondary ID [1]
306811
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
primary angle-closure glaucoma
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primary angle-closure suspect
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Condition category
Condition code
Eye
323199
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Neodymium-doped yttrium aluminium garnet (Nd:YAG) laser (Ellex Tango) will be used to perform the laser peripheral iridotomy procedure. One eye for each participant will undergo superior placement of the iridotomy hole and the other eye assigned temporal/nasal placement of the iridotomy hole. The procedure will be done at a private Sydney ophthalmology clinic by an experienced ophthalmologist. The procedure usually takes 5-10 minutes after which participants may return home. Participants included in the study will have one eye undergo superiorly placed laser peripheral iridotomy and the other assigned to temporal location by default. The procedure will be performed sequentially with the superior laser peripheral iridotomy (LPI) performed first. The selected eye will be based on presenting symptoms - in the eye with poorer visual acuity, clinically narrower angles and/or smaller anterior chamber depth. Within one week, the participant will undergo the second LPI performed temporally/nasally. Adherence to the intervention will be monitored using clinical notes.
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Intervention code [1]
323272
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Treatment: Other
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Comparator / control treatment
The comparator/control will be the patient's own eye that has undergone superior placement of laser peripheral iridotomy.
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Control group
Active
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Outcomes
Primary outcome [1]
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The presence of dysphotopsia symptoms will be self-reported by participants using a standardised questionnaire at follow up appointments. The questionnaire is designed specifically for this study.
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Assessment method [1]
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Timepoint [1]
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1 month and 6 months post-procedure
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Secondary outcome [1]
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Laser parameters including iridotomy hole size (in mm), number of shots used, and total laser energy used (kJ) will be documented during the procedure as per procedure protocol. An audit of study records will be performed retrospectively to collect this data.
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Assessment method [1]
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Timepoint [1]
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Intraoperative
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Secondary outcome [2]
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Post-procedure intraocular pressure (IOP) using tonometer
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Assessment method [2]
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Timepoint [2]
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Pre-procedure, at 1 month and 6 months post-procedure
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Secondary outcome [3]
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Incidence of post-procedure complications including transient post-op increase in IOP (using tonometer), iris bleeding (assessed by slit lamp examination) and occluded LPIs (determined by post-procedure IOP measured using tonometer) post-procedure requiring repeat LPI
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Assessment method [3]
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Timepoint [3]
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1 month and 6 months post-procedure
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Secondary outcome [4]
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Visual acuity using Snellen Chart
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Assessment method [4]
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Timepoint [4]
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Pre-procedure, 1 month and 6 months post-procedure
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Eligibility
Key inclusion criteria
1) Participants (>18 years old) diagnosed with primary angle closure glaucoma or primary angle-closure suspect in both eyes and requiring laser peripheral iridotomy intervention
2) Participants are able to attend required study visits
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) Participants who have undergone previous laser peripheral iridotomy procedure in either eye
2) Participants who have undergone previous intraocular surgery
3) Participants with asymmetrical ptosis of more than 2mm
4) Participants with any active intraocular inflammation at the time of undergoing laser peripheral iridotomy procedure
5) Participants with a history of acute-attack angle closure glaucoma
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
25/05/2022
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Actual
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Date of last participant enrolment
Anticipated
25/05/2023
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
138
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Primary sponsor type
Individual
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Name
Rachel Xuan
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Address
Dr Keith Ong Ophthalmology
2 Railway Avenue EASTWOOD NSW 2122
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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N/A
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Address [1]
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N/A
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Country [1]
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Northern Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
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Executive Unit, Level 14, Kolling Building, Royal North Shore Hospital,
Reserve Road, St Leonards NSW 2065
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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30/03/2022
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Approval date [1]
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Ethics approval number [1]
310675
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Summary
Brief summary
Laser peripheral iridotomy is used to treat narrow and closed-angle glaucoma and eyes with narrow anterior chamber angle to prevent progression to glaucoma. The laser peripheral iritodomy can be done in any location in the peripheral iris, however traditionally, it has been performed in the superior 12 o’clock position. The superior and temporal (3 o’clock for left eye, 9 o’clock for right eye) sites are the most common sites for laser peripheral iridotomy.
Rarely, some patients may experience visual disturbances after laser peripheral iridotomy. These are known as dysphotopsia symptoms and typically described as grey or blue horizontal or slightly curved line.
The purpose of this study is to assess the whether superior or temporal placement the iridotomy hole is associated with incidence of dysphotopsia symptoms. The hypothesis is that superiorly placed laser peripheral iridotomies are associated with reduced incidence of dysphotopsia symptoms.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Rachel Xuan
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Address
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Dr Keith Ong Ophthalmology
2 Railway Avenue, EASTWOOD NSW 2122
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Country
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Australia
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Phone
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+61 02 9858 3949
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Rachel Xuan
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Address
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Dr Keith Ong Ophthalmology
2 Railway Avenue, EASTWOOD NSW 2122
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Country
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Australia
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Phone
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+61 02 9858 3949
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Rachel Xuan
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Address
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Dr Keith Ong Ophthalmology
2 Railway Avenue, EASTWOOD NSW 2122
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Country
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Australia
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Phone
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+61 02 9858 3949
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Fax
118480
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Participant data collected will be de-identified prior to analysis. Analysis performed will collate individual participant data. This will be not be shared with other researchers.
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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.
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