Intravitreal Injections-related Anxiety

University Health Network, Toronto

Status and phase: Completed; Phase 3; Phase 2

Conditions: Age-related Macular Degeneration

Treatments: Behavioral: Printed materials; Behavioral: Video

Study type: Interventional

Funder types: Other

Identifiers

NCT02035722

UHN-110463AE

Details and patient eligibility

About

Intravitreal injection of Ranibizumab (Lucentis, Genentech) is clinically indicated for patients with wet age-related macular degeneration (AMD) An disadvantage of this technique is the anxiety and discomfort which patients often experience due to the idea of "getting a needle in the eye". In addition, a recent case study indicated the importance of patient education in achieving positive outcomes from intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents. The purpose of our study is to determine whether visual education on AMD and intravitreal injection can reduce patients' anxiety prior to the treatment, and lessen the impact of socioeconomical status on their understanding of the treatment and prognosis.

Full description

The use of intravitreal injections of Ranibizumab (Lucentis, Genentech) is becoming increasing common for the management of age-related macular degeneration (AMD). It is therefore important to acknowledge and address patients' anxiety due to anticipated discomfort from the idea of "getting a needle in the eye". In addition, visual provision of information at diagnosis concerning long-term treatment expectation may enhance the informed consent process. The use of visual aids may also accommodate patients of different educational background when presented with new and complex treatment information. The purpose of our study is to determine whether visual education on AMD and intravitreal injection can reduce patients' anxiety prior to the treatment, and lessen the impact of socioeconomical status on their understanding of the treatment and prognosis. Although this tool will be developed in the context of injection-requiring retinal diseases, it has applications in the care of disease requiring long-term treatments.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years and older
• AMD patients requiring intravitreal injections

Exclusion criteria

• Unable to read or comprehend English
• Any contraindications to intravitreal injections, such as IOP elevations

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 3 patient groups

Control group

No Intervention group

Description:

AMD-related information is not given to patients randomized to the control group.

Video materials

Active Comparator group

Description:

Educational materials are presented in through a video (audio and visual)

Treatment:

Behavioral: Video

Print materials

Active Comparator group

Description:

Educational materials are presented in the format of printed brochure (visual)

Treatment:

Behavioral: Printed materials