Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000463572
Ethics application status
Approved
Date submitted
31/03/2024
Date registered
15/04/2024
Date last updated
15/04/2024
Date data sharing statement initially provided
15/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Clinical Trial: Influence of Subconjunctival Anaesthesia Duration on Pain Perception During Intravitreal Injections
Scientific title
Randomised Clinical Trial: Influence of Subconjunctival Anaesthesia Duration on Pain Perception During Intravitreal Injections
Secondary ID [1] 311858 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intravitreal injection pain 333402 0
age-related macular degeneration 333403 0
retinal vein occlusion 333404 0
diabetic macular oedema 333405 0
Condition category
Condition code
Eye 330085 330085 0 0
Diseases / disorders of the eye
Anaesthesiology 330158 330158 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to determine the optimal wait time between the subconjunctival anaesthetic injection and intravitreal injection, whilst maintaining clinical efficiency. This is a Single-blinded randomised clinical trial. Patients were randomly assigned to one of four groups of wait time: 2 minutes, 3 minutes, 4 minutes, or 5 minutes.

Patient identification gets checked. Patient lies on the bed in supine position. Two drops of oxybuprocaine drops were installed to the eye. 5% povidone is used to sterilise the eye. Subconjunctival anaesthetic injection (0.2ml of 2% lidocaine) is given. After timing the assigned wait time (2, 3, 4 or 5 minutes), intravitreal injection (bevacizumab, ranibizumab, aflibercept - all 0.05ml in volume) was given using 30g needle. Eye gets irrigated with normal saline.

All injections were administered by two experienced injectors (one general practitioner, and one ophthalmology registrar). The questionnaire gets handed out to the patient to complete. Patients remain unaware of which group they get assigned to until they complete the questionnaire in order to reduce bias error.

For those requiring bilateral injections, only first injected eye gets included in the study.
Intervention code [1] 328317 0
Treatment: Other
Intervention code [2] 328318 0
Treatment: Drugs
Comparator / control treatment
Different wait time between subconjunctival anaesthetic injection and intravitreal injection delivery. 2 minutes, 3 minutes, 4 minutes, or 5 minutes. 3 minute group is the reference comparator.
Control group
Active

Outcomes
Primary outcome [1] 337838 0
Pain level graded by the patient on a 10-point visual analogue scale
Timepoint [1] 337838 0
at the end of intravitreal injection treatment delivery, on the same day.
Secondary outcome [1] 433441 0
the patient’s willingness to receive further intravitreal injection treatment with their experience on the day
Timepoint [1] 433441 0
at the end of intravitreal injection treatment delivery, on the same day

Eligibility
Key inclusion criteria
Enrollment included patients scheduled for IVI treatment at the injection clinic. Patients receiving bilateral injections had only their first injected eye included in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We excluded patients under 18, individuals with cognitive impairment, and those with communication challenges hindering informed consent and accurate questionnaire responses.

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)
folded note paper with wait time number written on it, stored in the opaque bag
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
patient drawing a note paper out of the bag randomly and handing it over to the injection without checking the number themselves
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/08/2020
Date of last participant enrolment
Anticipated
Actual
31/12/2020
Date of last data collection
Anticipated
Actual
31/12/2020
Sample size
Target
240
Accrual to date
Final
240
Recruitment outside Australia
Country [1] 26226 0
New Zealand
State/province [1] 26226 0

Funding & Sponsors
Funding source category [1] 316202 0
Hospital
Name [1] 316202 0
Christchurch Public Hospital, Eye clinic
Country [1] 316202 0
New Zealand
Primary sponsor type
Individual
Name
Jiyeon Kim
Address
Country
New Zealand
Secondary sponsor category [1] 318439 0
None
Name [1] 318439 0
Address [1] 318439 0
Country [1] 318439 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315019 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 315019 0
Ethics committee country [1] 315019 0
New Zealand
Date submitted for ethics approval [1] 315019 0
13/02/2020
Approval date [1] 315019 0
20/08/2020
Ethics approval number [1] 315019 0
20/CEN/32

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

Contacts
Principal investigator
Name 133442 0
Dr Jiyeon Kim
Address 133442 0
49 Riddiford Street, Newtown, Wellington, Eye clinic, Wellington Regional Hospital , 6021
Country 133442 0
New Zealand
Phone 133442 0
+64 211126457
Fax 133442 0
Email 133442 0
eyedoc0523@gmail.com
Contact person for public queries
Name 133443 0
Jiyeon Kim
Address 133443 0
49 Riddiford Street, Newtown, Wellington, Eye clinic, Wellington Regional Hospital , 6021
Country 133443 0
New Zealand
Phone 133443 0
+64 211126457
Fax 133443 0
Email 133443 0
eyedoc0523@gmail.com
Contact person for scientific queries
Name 133444 0
Jiyeon Kim
Address 133444 0
49 Riddiford Street, Newtown, Wellington, Eye clinic, Wellington Regional Hospital, 6021
Country 133444 0
New Zealand
Phone 133444 0
+64 211126457
Fax 133444 0
Email 133444 0
eyedoc0523@gmail.com

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?




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.