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Trial registered on ANZCTR
Registration number
ACTRN12619001464156
Ethics application status
Approved
Date submitted
18/09/2019
Date registered
22/10/2019
Date last updated
1/03/2023
Date data sharing statement initially provided
22/10/2019
Date results information initially provided
13/04/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Do latanoprost eye drops alter optic nerve stress signals in eyes with optic disc drusen?
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Scientific title
Latanoprost to alter optic nerve stress signals in eyes with optic disc drusen
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Secondary ID [1]
299344
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Nil known
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Universal Trial Number (UTN)
U1111-1240-6078
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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:
Optic disc drusen
314491
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Condition category
Condition code
Eye
312835
312835
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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
Latanoprost 0.005% eye drops to lower intraocular pressure. These are self administered by participants at home before bedtime once daily in both eyes for a total of one month until retesting (range 25-35 days). Bottles will be collected at completion, but the main test of compliance and efficacy will be a change in intraocular pressure.
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Intervention code [1]
315613
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Photopic negative response (PhNR), which is an electroretinogram physiological signal, measured with a hair-thin flexible electrode from the ocular surface using the Diagnosys LLC Color Burst mini-Ganzfeld stimulator, at standardised stimuli, and calculated as the ratio of PhNR to b-wave amplitude, to control for signal strength.
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Assessment method [1]
321443
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Timepoint [1]
321443
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Baseline and one month after treatment commencement (range 25-35 days)
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Primary outcome [2]
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Pattern electroretinogram (PERG), which is an electroretinogram physiological signal, measured with a hair-thin flexible electrode from the ocular surface using the Diagnosys LLC Envoy mini-OLED screen stimulator, at standardised checkerboard stimuli, and calculated as the ratio of small checks to large checks to improve specificity of signal.
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Assessment method [2]
321525
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Timepoint [2]
321525
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Baseline and one month after treatment commencement (range 25-35 days)
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Secondary outcome [1]
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Intraocular pressure (Goldmann applanation tonometry)
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Assessment method [1]
375875
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Timepoint [1]
375875
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Baseline and one month after treatment commencement (range 25-35 days)
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Eligibility
Key inclusion criteria
Diagnosed and verifiable optic disc drusen
Willing and able to give consent (parental assent for those under 18)
Baseline intraocular pressure of 15 mmHg or higher in one eye
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Minimum age
10
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
Inability to attend testing schedule
Allergy to prostaglandin eye drops
Active eye disease requiring treatment, ocular surgery within 6 months
Pregnancy (or possible pregnancy during month of treatment)
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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)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
Interventional cohort design, all participants tested before and after treatment
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Power and sample size calculation was performed based on published variance and meaningful differences in the PhNR electrophysiology signal, based on a paired two-group two-tailed comparison. Paired measurements before and after treatment will be recorded from each participant, as well as covariates of visual function and optic nerve structure. The primary outcome can be tested by paired t-test (or non-parametric equivalent), and multivariate regression may be possible.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
4/11/2019
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Actual
16/12/2019
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Date of last participant enrolment
Anticipated
5/10/2020
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Actual
17/07/2020
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Date of last data collection
Anticipated
2/11/2020
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Actual
14/08/2020
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Sample size
Target
16
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Accrual to date
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Final
23
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Recruitment outside Australia
Country [1]
21873
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New Zealand
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State/province [1]
21873
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Funding & Sponsors
Funding source category [1]
303858
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University
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Name [1]
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University of Otago Wellington
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Address [1]
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23 Mein St
Newtown
PO Box 7343
Wellington South 6242
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Country [1]
303858
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New Zealand
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Primary sponsor type
Individual
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Name
Jesse Gale
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Address
Capital Eye Specialists
Level 2, 148 Cuba St
Wellington 6011
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Country
New Zealand
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Secondary sponsor category [1]
303996
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None
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Name [1]
303996
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Address [1]
303996
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Country [1]
303996
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304370
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Health and Disability Ethics Committee (NZ)
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Ethics committee address [1]
304370
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Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
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Ethics committee country [1]
304370
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New Zealand
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Date submitted for ethics approval [1]
304370
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27/09/2019
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Approval date [1]
304370
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10/12/2019
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Ethics approval number [1]
304370
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HDEC Ethics ref: 19/CEN/177
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Summary
Brief summary
Optic disc drusen (ODD) are common benign calcified deposits in the front of the optic nerve, and some doctors treat them as a type of glaucoma, by lowering the eye pressure, because the progressive visual field defects are similar. This treatment has never been tested because ODD are generally slow-changing. With new electrical recordings we seek to test whether the optic nerve cells are stressed in ODD and whether glaucoma treatment increases or decreases this stress signal.
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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
96718
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Dr Jesse Gale
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Address
96718
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Capital Eye Specialists
Level 2, 148 Cuba St
Wellington 6011
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Country
96718
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New Zealand
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Phone
96718
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+64211272979
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Fax
96718
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+6443844937
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Email
96718
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[email protected]
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Contact person for public queries
Name
96719
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Dr Jesse Gale
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Address
96719
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Capital Eye Specialists
Level 2, 148 Cuba St
Wellington 6011
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Country
96719
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New Zealand
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Phone
96719
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+64211272979
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Fax
96719
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+6443844937
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Email
96719
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[email protected]
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Contact person for scientific queries
Name
96720
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Dr Jesse Gale
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Address
96720
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Capital Eye Specialists
Level 2, 148 Cuba St
Wellington 6011
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Country
96720
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New Zealand
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Phone
96720
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+64211272979
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Fax
96720
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+6443844937
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Email
96720
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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)?
Yes
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What data in particular will be shared?
Our anonymised spreadsheet of participant data including extracted metrics from electrophysiology, visual fields, and optical coherence tomography, as well as intraocular pressure, visual acuity and colour vision scores.
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When will data be available (start and end dates)?
The data will be available on request from 1 Jan 2021, after all data collection, analysis and writing is complete. Data availability end date to be determined.
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Available to whom?
Colleagues and reviewers without conflicts of interest
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Available for what types of analyses?
Verification of our findings, we expect that all meaningful analyses will be performed by our investigators, these data are for transparency
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How or where can data be obtained?
By email request to the corresponding author, as with supporting documents,
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
4939
Study protocol
[email protected]
4940
Informed consent form
[email protected]
4941
Ethical approval
[email protected]
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Plain language summary
No
Twenty three people with optic disc drusen partici...
[
More Details
]
Documents added automatically
No additional documents have been identified.
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