Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000468426
Ethics application status
Approved
Date submitted
29/04/2025
Date registered
16/05/2025
Date last updated
16/05/2025
Date data sharing statement initially provided
16/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Video Informed DEcisiOn-Making (VIDEO-2) for Patients Undergoing Incisional Glaucoma Surgery: A Randomised Control Trial to evaluate if the addition of a targeted patient information video improves the shared decision-making process when compared to standard processes for patients considering incisional glaucoma surgery.
Scientific title
Video Informed DEcisiOn-Making (VIDEO-2) for Patients Undergoing Incisional Glaucoma Surgery: A Randomised Control Trial into patient anxiety, satisfaction and understanding of concepts within the informed consent process with the addition of video education.
Secondary ID [1] 314255 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 337176 0
Condition category
Condition code
Eye 333593 333593 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the intervention group: A 12-minute-long informative video which uses a realistic animation style to accurately depict the eye undergoing incisional surgery whilst a voiceover explains the process will be presented. The video explores what glaucoma is, why surgery is being recommended, the type of surgery they will be receiving, what the surgery involves, an animation demonstrating the surgery, risks and complications of the surgery, effectiveness, and expected postoperative events. The video will include audio descriptions but no subtitles have been added thus far. Participants will be able to view the video as many times as they desire. The video has been specifically designed for this study, and therefore is not a readily available resource yet. There are currently not any strategies to monitor adherence to the video. The intervention group will also receive the Royal Australian and New Zealand College of Ophthalmologists (RANZCO) brochure.
Intervention code [1] 330867 0
Behaviour
Comparator / control treatment
The control group will only receive the RANZCO brochure "Surgical Treatment of Glaucoma" (usual standard care), which introduces pathological and physiological concepts of glaucoma to patients in an accessible manner, tone and language, explains diagnosis of glaucoma and relevance of intraocular pressure, and explores primary open-angle glaucoma, acute angle-closure glaucoma, and normal-tension glaucoma. The brochure also uses three diagrams to explain the normal eye anatomy, and open- and closed-angle glaucoma. Mi-tec Medical Publishing produces the brochure.
Control group
Active

Outcomes
Primary outcome [1] 341172 0
Any difference in anxiety between control and intervention groups
Timepoint [1] 341172 0
- 1 week post surgery (which is also post-intervention or control viewing)
Secondary outcome [1] 446648 0
Any difference in information retention/understanding between the control and intervention groups. (Assessed as a composite secondary outcome).
Timepoint [1] 446648 0
- 1 week post surgery (which is also post-intervention or control viewing) - 2 months post surgery (which is also post-intervention or control viewing)
Secondary outcome [2] 446807 0
Any difference in satisfaction between the control and intervention groups
Timepoint [2] 446807 0
- 1 week post surgery (which is also post-intervention or control viewing) - 2 months post surgery (which is also post-intervention or control viewing)

Eligibility
Key inclusion criteria
- Diagnosis of glaucoma
- Being considered for Incisional Glaucoma Surgery (trabeculectomy, tube shunt, or minimally invasive glaucoma surgery device)
- > 18-years-old
- English speaking
- Is a patient of Port Macquarie Eye Centre (PMEC) or other approved research sites (must be a private ophthalmology clinic)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Immediate family member receiving incisional glaucoma surgery during the same time period
- Combined glaucoma and cataract surgery
- Combined visual and auditory impairment resulting in an inability to engage with video as determined by the ophthalmologist
- Inability to give informed consent as determined by the ophthalmologist
- Primary angle closure glaucoma requiring laser or surgical iridotomy, iridoplasty, or iridectomy as these are performed under urgent conditions
- No access to an electronic device with internet connectivity


Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Randomisation will be stratified to each surgeon.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
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
19/05/2025
Actual
Date of last participant enrolment
Anticipated
1/05/2026
Actual
Date of last data collection
Anticipated
29/05/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 43996 0
2444 - Port Macquarie

Funding & Sponsors
Funding source category [1] 318778 0
Self funded/Unfunded
Name [1] 318778 0
Country [1] 318778 0
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 321216 0
None
Name [1] 321216 0
Address [1] 321216 0
Country [1] 321216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317386 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 317386 0
Ethics committee country [1] 317386 0
Australia
Date submitted for ethics approval [1] 317386 0
20/03/2024
Approval date [1] 317386 0
08/05/2025
Ethics approval number [1] 317386 0
iRECS6135

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

Contacts
Principal investigator
Name 140890 0
Dr Hamish Dunn
Address 140890 0
Port Macquarie Eye Centre, 35 Ackroyd Street PORT MACQUARIE NSW 2444
Country 140890 0
Australia
Phone 140890 0
+61 2 6584 5554
Fax 140890 0
Email 140890 0
[email protected]
Contact person for public queries
Name 140891 0
Antonia Amato
Address 140891 0
Port Macquarie Eye Centre, 35 Ackroyd Street PORT MACQUARIE NSW 2444
Country 140891 0
Australia
Phone 140891 0
+61 475 259 442
Fax 140891 0
Email 140891 0
[email protected]
Contact person for scientific queries
Name 140892 0
Antonia Amato
Address 140892 0
Port Macquarie Eye Centre, 35 Ackroyd Street PORT MACQUARIE NSW 2444
Country 140892 0
Australia
Phone 140892 0
+61 475 259 442
Fax 140892 0
Email 140892 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 7 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Dr Hamish Dunn [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    PISCF v3_clean (1).docx
Study protocol    Video Consent Protocol.pdf


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.