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Intravitreal Injections-related Anxiety

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ClinicalTrials.gov Identifier: NCT02035722
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Behavioral: Printed materials Behavioral: Video Phase 2 Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Visual Approach to Reducing Anxiety and Improving Knowledge Transfer for Patients Receiving Intravitreal Injections
Study Start Date : September 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014

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Arm Intervention/treatment
No Intervention: Control group
AMD-related information is not given to patients randomized to the control group.
Active Comparator: Video materials
Educational materials are presented in through a video (audio and visual)
Behavioral: Video
AMD-related information is presented as in the form of a video

Active Comparator: Print materials
Educational materials are presented in the format of printed brochure (visual)
Behavioral: Printed materials
AMD-related information is presented to patients in the form of a brochure (i.e. printed materials)




Primary Outcome Measures :
  1. Anxiety [ Time Frame: Cross-sectional study, where questionnaires will be completed on the same day of clinic visit. ]

Secondary Outcome Measures :
  1. Knowledge of AMD [ Time Frame: Cross-sectional study, where questionnaires will be completed on the same day of clinic visit. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035722


Locations
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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Wai-Ching Lam University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02035722    
Other Study ID Numbers: UHN-110463AE
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases