Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000324819p
Ethics application status
Not yet submitted
Date submitted
24/11/2020
Date registered
23/03/2021
Date last updated
23/03/2021
Date data sharing statement initially provided
23/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Selective laser trabeculoplasty in high-risk glaucoma suspects: a randomized controlled trial.
Scientific title
In high-risk glaucoma suspects, does selective laser trabeculoplasty, compared to a sham procedure, influence progression to perimetric glaucoma.
Secondary ID [1] 302853 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SINERGGI (SLT INtervention for EaRly Glaucoma in Genetically at-risk Individuals)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 319832 0
Condition category
Condition code
Eye 317775 317775 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Selective laser trabeculoplasty (SLT) will be delivered using a Tango SLT device (Ellex). Topical anaesthetic drops will be administered prior to treatment, with SLT administered in a single sitting by an experienced consultant ophthalmologist using a laser gonioscopy lens to 360° of the trabecular meshwork through 100 non-­overlapping laser shots (25 per quadrant), with laser energy varying from 0·3 to 1·4 mJ, using a clinical endpoint of fine bubble formation at the trabecular meshwork at least 50% of the time. The duration of the procedure is approximately 5 minutes per eye.
Intervention code [1] 319134 0
Prevention
Intervention code [2] 319677 0
Treatment: Devices
Comparator / control treatment
In the sham selective laser trabeculoplasty (SLT) group, an identical treatment protocol will be followed, with the addition of a full green blocking filter applied to block treatment laser energy, yet will retain all other aspects of the SLT treatment protocol (including a visible aiming beam, slit-lamp illumination, and an audible ‘click’ with each laser shot). A Corvis biomechanically-corrected IOP (bIOP) measurement will be performed 6 weeks after each procedure, by clinicians blinded to subject allocation. Corvis bIOP is non-subjective, and there are no visible effects of SLT.
Control group
Placebo

Outcomes
Primary outcome [1] 325800 0
Composite primary outcome of development of a reproducible glaucomatous visual field defect (as measured by 24-2 SITA Standard Humphrey Visual Field (HVF) testing), or a reproducible biomechanical corrected intraocular pressure (bIOP) >28mmHg (as measured by an OCULUS Corvis ST device).
Timepoint [1] 325800 0
HVF and bIOP testing will be performed at baseline (pre-intervention), and 6/12/18/24/30/36 months post-intervention.
Secondary outcome [1] 389181 0
Rate of the pointwise total deviation change on 24-2 SITA Standard Humphrey Visual Field (HVF) testing.
Timepoint [1] 389181 0
HVF testing will be performed at baseline (pre-intervention), and 6/12/18/24/30/36 months post-intervention.
Secondary outcome [2] 391508 0
Rate of the global mean deviation change on 24-2 SITA Standard Humphrey Visual Field (HVF) testing.
Timepoint [2] 391508 0
HVF testing will be performed at baseline (pre-intervention), and 6/12/18/24/30/36 months post-intervention.
Secondary outcome [3] 391509 0
Retinal nerve fibre layer loss in microns/year as measured by ocular coherence tomography (OCT).
Timepoint [3] 391509 0
OCT testing will be performed at baseline (pre-intervention), and 6/12/18/24/30/36 months post-intervention.

Eligibility
Key inclusion criteria
1. Ability to understand and sign a written informed consent form prior to initiation of study
2. Males and females aged 18-85 years (inclusive)
3. Glaucoma suspect (in one or both eyes) based on:
a. Optic disc assessment and DDLS grade > 2 (glaucoma suspect).
b. Ocular hypertension (bIOP >22 and <28 mmHg) any disc grade.
4. Open drainage angles on gonioscopy.
5. May include pseudoexfoliation.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. BCVA < 6/18 (either eye).
2. Confirmed perimetric glaucoma (either eye).
3. Active treatment for another ophthalmic condition, or participation in another interventional trial
4. Retinal, optic nerve, or neurological disease causing a visual field defect.
5. Pigment dispersion syndrome.
6. Cognitive impairment or other inability to perform reliable HVF.
7. Contraindications to SLT (unable to sit, active uveitis, insufficient view of trabecular meshwork due to narrow drainage angles or PAS).
8. Symptomatic cataract.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS

Funding & Sponsors
Funding source category [1] 307273 0
Self funded/Unfunded
Name [1] 307273 0
Country [1] 307273 0
Primary sponsor type
Individual
Name
Professor Jamie Craig
Address
Flinders University
1 Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 307897 0
None
Name [1] 307897 0
Address [1] 307897 0
Country [1] 307897 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 307369 0
Bellberry Limited
Ethics committee address [1] 307369 0
123 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 307369 0
Australia
Date submitted for ethics approval [1] 307369 0
01/06/2021
Approval date [1] 307369 0
Ethics approval number [1] 307369 0

Summary
Brief summary
Glaucoma is the leading cause of irreversible blindness worldwide. The SINERGGI study will determine if early laser treatment in high-risk individuals can prevent glaucoma blindness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106990 0
Prof Jamie Craig
Address 106990 0
Flinders University
1 Flinders Drive
Bedford Park SA 5042
Country 106990 0
Australia
Phone 106990 0
+61 8 82044624
Fax 106990 0
Email 106990 0
jamie.craig@flinders.edu.au
Contact person for public queries
Name 106991 0
Ms Deb Sullivan
Address 106991 0
Flinders University
1 Flinders Drive
Bedford Park SA 5042
Country 106991 0
Australia
Phone 106991 0
+61 8 82045737
Fax 106991 0
Email 106991 0
deb.k.sullivan@flinders.edu.au
Contact person for scientific queries
Name 106992 0
Prof Jamie Craig
Address 106992 0
Flinders University
1 Flinders Drive
Bedford Park SA 5042
Country 106992 0
Australia
Phone 106992 0
+61 8 82045737
Fax 106992 0
Email 106992 0
jamie.craig@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.