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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Glaucoma

Condition category

Condition code

Eye

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]

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]

Any difference in anxiety between control and intervention groups

Timepoint [1]

- 1 week post surgery (which is also post-intervention or control viewing)

Secondary outcome [1]

Any difference in information retention/understanding between the control and intervention groups. (Assessed as a composite secondary outcome).

Timepoint [1]

- 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]

Any difference in satisfaction between the control and intervention groups

Timepoint [2]

- 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?

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]

2444 - Port Macquarie

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

University of New South Wales

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of New South Wales Research Ethics Committee A

Ethics committee address [1]

https://research.unsw.edu.au/research-ethics-and-compliance-support-recs

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/03/2024

Approval date [1]

08/05/2025

Ethics approval number [1]

iRECS6135

Summary

Brief summary

This research is essential as it will to overcome the documented discrepancies in patient understanding and provide a video reference tool for patients to facilitate better engagement in decision making. The research is expected to benefit patients undergoing incisional glaucoma surgery and ophthalmologists, allowing them to improve their consultations and provide more effective and efficient patient-centred care.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Hamish Dunn

Address

Port Macquarie Eye Centre, 35 Ackroyd Street PORT MACQUARIE NSW 2444

Country

Australia

Phone

+61 2 6584 5554

Fax

[email protected]

Contact person for public queries

Name

Antonia Amato

Address

Port Macquarie Eye Centre, 35 Ackroyd Street PORT MACQUARIE NSW 2444

Country

Australia

Phone

+61 475 259 442

Fax

[email protected]

Contact person for scientific queries

Name

Antonia Amato

Address

Port Macquarie Eye Centre, 35 Ackroyd Street PORT MACQUARIE NSW 2444

Country

Australia

Phone

+61 475 259 442

Fax

[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?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24679	Informed consent form					PISCF v3_clean (1).docx
24680	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.

Trial Review

Documents added manually

Documents added automatically