Article Figures & Data
Figures
- Figure 1
Concept device design and features.
- Figure 2
Dose marking design alternatives.
- Figure 3
Tamper-evident tip cap design.
- Figure 4
Prototype instructions for use.
- Figure 5
Participant evaluation of ease of use.
- Figure 6
Participant evaluation of comfort and safety. IVI = intravitreal injection.
- Figure 7
Participant evaluation of specific use steps. IVI = intravitreal injection.
- Figure 8
Participant preferences for IVI devices. IVI = intravitreal injection.
Tables
Medication Packaging Configuration(s) pegaptanib Single-dose glass prefilled luer lock syringe supplied with a 30-gauge injection needle aflibercept Single-dose glass vial supplied with a 19-gauge filter needle, 30-gauge injection needle, and 1 mL plastic luer lock syringe ranibizumab Single-dose glass vial (supplies are not included); Single-dose glass prefilled luer lock syringe (supplies are not included) bevacizumab Single-dose glass vial (supplies are not included) VEGF = vascular endothelial growth factor
Participant ID Years of Experience Number of IVIs Administered per week Age Range Most Common IVI(s) Administered RS01 1–5 25 25–34 aflibercept RS02 10–25 75 35–44 aflibercept RS03 6–10 100 35–44 aflibercept RS04 10–25 100 45–54 aflibercept RS05 1–5 50 35–44 ranibizumab PFS, ranibizumab vial, aflibercept RS06 6–10 10 35–44 ranibizumab PFS RS07 6–10 30 35–44 ranibizumab PFS, aflibercept RS08 6–10 100 45–54 * RS09 25+ 50 55–64 aflibercept RS10 6–10 50 35–44 aflibercept RS11 6–10 40 35–44 aflibercept RS12 25+ 18 55–64 aflibercept RS13 10–25 15 45–54 aflibercept IVI = intravitreal injection.
↵* Did not provide information.
Assessment Definition Successful with No Issues (S) The participant was able to complete the task successfully per the evaluation criteria. Use Event Participant action or lack of action did not meet the evaluation criteria for the task. Use events were classified as either I or R. Incomplete/Incorrect (I) The participant did not complete the task as intended. Resolved (R) The participant struggled, described difficulty, or encountered a close call such as taking or describing some action that would have otherwise resulted in incomplete/incorrect use. The resolved use events were assigned to either OD or CC upon root cause analysis. Operational Difficulty (OD) The participant was able to complete the task safely and effectively but had significant hesitation or challenges while completing the task. Close Call (CC) The participant had difficulty or took an action that could have resulted in harm but took additional action to recover and prevent the potential harm from occurring (i.e., “near miss”). Study Artifact (SA) The participant experienced a use error in the simulated use study that would not occur in real practice. Study artifacts were removed from overall task performance totals and summarized separately. Not Assessed (NA) The participant was unable to complete the task because of a previous usability issue that rendered it impossible to perform the task. Performance that was scored as not assessed was removed from overall task performance totals and summarized separately. Success Resolved Incomplete or Incorrect Study Artifact Not Assessed Inspect tip cap (E) 4/13 0/13 9/13 0/13 0/13 Remove tip cap by twisting, not breaking (E) 11/13 1/13 1/13 0/13 0/13 Attach needle to syringe by twisting (E) 13/13 0/13 0/13 0/13 0/13 Remove needle shield by pulling (E) 13/13 0/13 0/13 0/13 0/13 Consolidate air bubbles (SC) 10/13 0/13 3/13 0/13 0/13 Expel air bubbles (SC) 12/13 0/13 1/13 0/13 0/13 Set dose to 0.05 mL (SC) 10/13 1/13 2/13 0/13 0/13 Administer intravitreal injection (E) 12/13 0/13 1/13 0/13 0/13 Remove syringe from injection site (E) 13/13 0/13 0/13 0/13 0/13 Dispose of syringe (SC) 12/13 0/13 0/13 1/13 0/13 TOTAL 110/130 2/130 17/130 1/130 0/130 E = Essential; SC = Safety-Critical.
Use Error Description Number of Occurrences Number of Participants Did not inspect the tip cap 9 9 of 13 Did not remove the tip cap 1 1 of 13 Did not consolidate air 3 3 of 13 Did not expel air 1 1 of 13 Did not set the dose properly 2 2 of 13 Pulled the needle out of the eye prematurely 1 1 of 13
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