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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05570591
Registration number
NCT05570591
Ethics application status
Date submitted
4/10/2022
Date registered
6/10/2022
Date last updated
29/03/2023
Titles & IDs
Public title
Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy
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Scientific title
Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy: A Double-masked Sham-controlled Randomised Trial
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Secondary ID [1]
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NANO-C
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Universal Trial Number (UTN)
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Trial acronym
NANO-C
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Central Serous Chorioretinopathy
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Condition category
Condition code
Eye
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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
Treatment: Devices - 2RT subthreshold nanosecond laser - active
Treatment: Devices - 2RT subthreshold nanosecond laser - sham
Active Comparator: Active laser - Application of the active 2RT sub threshold laser
Sham Comparator: Sham laser - Application of sham laser (i.e. flashing lights which replicate the look of active laser to the participant)
Treatment: Devices: 2RT subthreshold nanosecond laser - active
The 2RTâ„¢ Q-switched YAG laser (532nm) delivering 3 nanosecond pulses; 400 um spot size, is a pulsed subthreshold nanosecond (SNL) laser, which uses low energy levels to produce limited effects that selectively target melanosomes within the pigmented retinal pigment epithelial (RPE) cells.
Treatment: Devices: 2RT subthreshold nanosecond laser - sham
Application of sham laser (i.e. flashing lights which replicate the look of active laser to the participant) from the 2RT subthreshold nanosecond laser device.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Resolution of sub-retinal fluid in study eyes
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Assessment method [1]
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The change in amount of sub-retinal fluid (SRF) as observed on optical coherence tomography (OCT) imaging in the SNL-treated compared to sham-treated study eyes over 24 weeks.
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Timepoint [1]
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24 weeks
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Eligibility
Key inclusion criteria
1. Age 18-70 years
2. Both males and females
3. Individuals with non-resolving CSCR as defined by presence of any SRF on OCT for > 3
months from date of diagnosis to randomisation visit
4. BCVA of 35 to 80 letters (Snellen equivalent of 6/6 to 6/60) in the study eye
5. Ability, willingness and sufficient cognitive awareness to consent to the trial,
received randomised SNL treatment or sham procedure, and complete all visits as per
the study schedule
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Minimum age
18
Years
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Maximum age
70
Years
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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. A need for extraneous, continuous steroids to control any disease, including both
systemic steroids (e.g., for systemic autoimmune conditions) and ocular steroids
(e.g., for uveitis), or ongoing anabolic steroid use
2. Any systemic disease that leads to elevated endogenous steroid levels including raised
24h urinary cortisol level > 100 ug/24h consistent with Cushing's syndrome
3. Any ocular disease in the study eye, other than CSCR, which in the opinion of the
investigator may significantly compromise assessment of the retina, or which would
compromise the ability to assess any effect following SNL treatment including, but not
limited to:
- Age related macular degeneration
- Any evidence of a neovascular membrane in the macular (either exudative or
non-exudative)
- Diabetic retinopathy (unless limited to fewer than 10 microaneurysms and/or small
retinal haemorrhages, without retinal thickening on OCT)
- Macular pathology or pigmentary abnormalities including but not limited to:
pattern dystrophy, myopic maculopathy, angioid streaks, resumed ocular
histoplasmosis syndrome, visually-significant epiretinal membranes, macular hole
or pseudohole
- Optic nerve pathology, including optic atrophy, history of optic neuropathy
- Myopic crescent wider than 50% of the longest diameter of the optic disc, or
closer than 1500 µm to the fovea
- Retinal vascular diseases including branch or central vein or artery occlusion
- Choroidal nevus within 2 DD of the fovea associated with depigmentation or
overlying drusen, if these drusen are used to determine eligibility
- Active uveitis or ocular inflammation
- Corneal pathology precluding visualization of fundus or increasing the risk of
using a contact lens, such as corneal dystrophy, recurrent corneal erosion
syndrome or sensitivity to the application of a contact lens
4. History or presence of uncontrolled glaucoma or raised intraocular pressure which
would preclude safe dilation of the pupil to allow adequate assessment and application
of SNL treatment
5. History of prior laser surgery to the retina including subthreshold laser (focal
retinopexy for a peripheral retinal tear performed more than 90 days prior to the
entry into the study is permitted)
6. Significant cataract or other ocular media which, in the opinion of the investigator,
significantly limits the visual acuity or view of the retina
7. Cataract surgery within three months preceding baseline, or a history of
post-operative complications within the last 12 months preceding baseline in the study
eye (uveitis, cyclitis, etc.)
8. Previous retinal or ocular surgery, the effects of which may now or in the future
complicate assessment of CSCR (routine cataract surgery more than 3 months prior is
permitted)
9. Known hypersensitivity to fluorescein
10. Use of any systemic or ocular medication known to be toxic to the retina, excluding
tamoxifen unless there is evidence of toxicity
11. Pregnant or lactating women
12. Current participation in any other investigational ophthalmological clinical trial
13. Other health-related reasons which make an individual inappropriate for participation
in this study based on the investigator's medical judgment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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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
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/10/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2023
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Centre for Eye Research Australia - East Melbourne
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Recruitment hospital [2]
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Retinology Institute - Glen Iris
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Recruitment postcode(s) [2]
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3146 - Glen Iris
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Nova Eye Medical Pty Ltd.
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Centre for Eye Research Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a prospective, multicentre, sham-controlled, participant- and assessor-masked
superiority trial with two parallel treatment arms which aims to investigate the safety and
efficacy of subthreshold nanosecond laser (SNL) in a series of adults with sub-retinal fluid
secondary to non-resolving central serous chorioretinopathy (CSCR) by visual and anatomical
outcomes.
The study population will be individuals with adults (aged 18-70 years inclusive) with
non-resolving CSCR (defined as CSCR present for a duration of more than 3 months presenting
with either focal or diffuse leakage) who meet all eligibility criteria.
60 subjects total will be enrolled into the study - 40 randomized to receive SNL treatment
and 20 to receive sham treatment as per a 2:1 randomization schedule and stratified by type
of CSCR (focal vs diffuse).
The study has a 24-week study period with five scheduled visits: screening, randomisation
(first treatment), 6-week follow up (with second treatment where eligible), 12-week follow-up
, 18-week follow-up, and 24-week follow-up.
The primary outcome is the proportion of laser-treated study eyes that show resolution of
sub-retinal fluid (SRF) as observed on optical coherence tomography (OCT) compared to
sham-treated study eyes at 24 weeks.
The safety endpoint will be proportion of laser-treated eyes that lose =10 letters of of
vision (measured on a standard vision chart) compared to sham-treated study eyes and fellow
eyes over 24 weeks.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05570591
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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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Mali Okada, MBBS FRANZCO
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Address
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Centre for Eye Research Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Tom Spurling
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Address
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Country
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Phone
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+61 8 8362 0193
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05570591
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