Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001309370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/10/2026
Date registered
Help: Date registered
30/10/2026
Date last updated
Help: Date last updated
30/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/10/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Periorbital Vibration Anaesthesia on Patient Experience During Intravitreal Injections: A Randomised Controlled Trial
Scientific title
In adults undergoing intravitreal injections, does periorbital vibration compared with standard care improve their treatment experience?
Additional trial identifiers [1] 318672 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Age-related macular degeneration 343882 0
Diabetic macular oedema 344014 0
Retinal vein occlusion 344015 0
Condition category
Condition code
Eye 340027 340027 0 0
Diseases / disorders of the eye
Anaesthesiology 340142 340142 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Patients will receive periorbital vibration using the Dermacuro Pain Blocker Vibration Neural Distraction Device, a handheld device that delivers mechanical vibration to the periorbital region, during their intravitreal injection procedure. The intervention will be delivered individually, face-to-face, by a research investigator or clinic nursing staff in the Ophthalmology Clinic. The device will be applied prior to speculum insertion and continued until the injection needle has been removed from the eye, for approximately 1–2 minutes depending on the duration of the procedure. The intervention will be administered once per participant at a single study visit. Delivery of the intervention will be documented by the research team at the study visit.
Intervention code [1] 335565 0
Treatment: Devices
Description of the comparator or control
Participants allocated to the control group will receive their intravitreal injection according to routine clinical practice, without the use of the Dermacuro Pain Blocker Vibration Neural Distraction Device. The procedure will be performed by a clinician with assistance from clinic nursing staff as required. The procedure will be delivered individually, face-to-face, in the Ophthalmology Clinic at a single study visit. The participant’s allocation to the control group will be documented by the research team at the study visit.
Control group
Active

Outcomes
Primary outcome [1] 347179 0
Pain
Timepoint [1] 347179 0
Immediately following intravitreal injection
Primary outcome [2] 347180 0
Anxiety
Timepoint [2] 347180 0
Immediately following intravitreal injection
Primary outcome [3] 347181 0
Satisfaction
Timepoint [3] 347181 0
Immediately following intravitreal injection
Secondary outcome [1] 469350 0
Nil
Timepoint [1] 469350 0
N/A

Eligibility
Key inclusion criteria
Adults aged 18 years or older requiring an intravitreal injection at the Royal Adelaide Hospital Ophthalmology Clinic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Unable to consent, not fluent in English or has underlying cognitive impairment or mental disability.

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to either the intervention group or the control group using computer-generated permuted block randomisation, with a 1:1 allocation ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total sample size of 126 participants (63 per group) is required to detect a clinically meaningful between-group difference of 10 points in mean numeric rating scale (NRS) pain score, assuming a standard deviation of 20 points, a two-sided significance level of 0.05 and 80% power. The target recruitment has been increased to 134 participants (67 per group) to allow for potential participant withdrawal and incomplete data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/06/2026
Date of last participant enrolment
Anticipated
Actual
28/08/2026
Date of last data collection
Anticipated
Actual
28/08/2026
Sample size
Target
134
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 30358 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 46775 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 323242 0
Hospital
Name [1] 323242 0
Royal Adelaide Hospital
Country [1] 323242 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 326209 0
None
Name [1] 326209 0
Address [1] 326209 0
Country [1] 326209 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321637 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 321637 0
Ethics committee country [1] 321637 0
Australia
Date submitted for ethics approval [1] 321637 0
23/01/2026
Approval date [1] 321637 0
13/05/2026
Ethics approval number [1] 321637 0
22526

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 154354 0
Prof Robert Casson
Address 154354 0
Royal Adelaide Hospital, Port Rd, Adelaide, 5000, South Australia
Country 154354 0
Australia
Phone 154354 0
+61 418 857 813
Fax 154354 0
Email 154354 0
[email protected]
Contact person for public queries
Name 154355 0
Layla Bunjo
Address 154355 0
Royal Adelaide Hospital, Port Rd, Adelaide, 5000, South Australia
Country 154355 0
Australia
Phone 154355 0
+61 8 7074 0000
Fax 154355 0
Email 154355 0
[email protected]
Contact person for scientific queries
Name 154356 0
Robert Casson
Address 154356 0
Royal Adelaide Hospital, Port Rd, Adelaide, 5000, South Australia
Country 154356 0
Australia
Phone 154356 0
+61 8 7074 0000
Fax 154356 0
Email 154356 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.