Table 2.
First author, year |
Study design | Interventions | Number of patients/ eyes/injections/ clinicians |
Outcome(s) | Key results |
---|---|---|---|---|---|
Michaud 2014 [16] |
Cross-sectional |
RBZ PFS RBZ vial |
Not specified |
Silicon oil migration Product stability |
Minimal silicone oil migration into solution in RBZ PFS No relevant difference in product stability between RBZ PFS and vial RBZ PFS is easy to hold and may increase the injection preparation efficiency by saving clinicians' time vs. vial |
Woodcock 2014 [17] |
Cross-sectional |
RBZ PFS RBZ vial |
Not specified | Product stability | No difference in product stability between RBZ PFS and vial |
Souied 2015 [18] |
Cross-sectional |
RBZ PFS RBZ vial |
Syringe preparations Center 1 RBZ PFS 39 RBZ vial 24 Center 2 RBZ PFS 18 RBZ vial 16 |
Syringe preparation time (mean ± SD) |
Center 1 RBZ PFS 46.0 ± 7.3 s RBZ vial 75.3 ± 14.7 s (p < 0.001) Center 2 RBZ PFS 45.8 ± 9.8 s RBZ vial 62.8 ± 15.6 s (p < 0.01) |
Subhi 2016 [19] |
Cross-sectional |
RBZ PFS RBZ vial AFL vial |
Syringe preparations RBZ PFS 56 RBZ vial 56 AFL vial 60 |
Syringe preparation time (mean ± SD) |
RBZ PFS 16.9 ± 3.6 s RBZ vial 40.3 ± 6.7 s (p < 0.0001) AFL vial 45.1 ± 6.9 s (p = 0.0014) |
Ayan 2017 [20] |
Cross-sectional |
RBZ PFS RBZ vial |
Syringe preparations RBZ PFS 24 RBZ vial 24 |
Syringe preparation time (mean ± SD) |
Syringe preparation time RBZ PFS 40.3 ± 7.62 s RBZ vial 98.0 ± 25.23 s Difference − 57.8 s; 95% CI − 67.67 to − 47.91 (p < 0.0001) |
Antoszyk 2018 [41] |
Simulated and actual use human factor | RBZ PFS |
Simulated use Retina specialists 15 Ophthalmic medical personnel 15 Actual use Retina specialists 3 Assistants 3 Patients 35 |
12 tasks specific to the unpacking, preparing, and proper administration | All participants successfully performed all essential and safety–critical tasks without use error in both the simulated use and actual use human factors usability studies |
Loewenstein 2019 [23] |
Cross-sectional |
RBZ PFS AFL vial |
Injections RBZ PFS 125 AFL vial 112 |
Injection volume | Volume: RBZ PFS more precise vs. AFL vial |
Ugurlu 2021 [29] |
Cross-sectional |
RBZ PFS RBZ vial AFL vial |
Injections RBZ PFS 45 RBZ vial 36 AFL vial 36 |
Syringe preparation time (mean ± SD) |
RBZ PFS 46.5 ± 4.8 s RBZ vial 64.2 ± 5.1 s AFL vial 74.7 ± 8.5 s Time significantly lower for RBZ PFS |
Ulaş 2021 [30] |
Cross-sectional |
RBZ PFS RBZ vial AFL vial |
Injections 90 Patients injected RBZ PFS 15 RBZ vial 15 AFL vial 15 |
Syringe preparation + injection time (mean ± SD) |
Clinician 1 RBZ PFS 50.29 ± 11.31 s RBZ vial 82.31 ± 21.52 s (p < 0.001) AFL vial 71.90 ± 16.57 s (p < 0.001) Clinician 2 RBZ PFS 57.86 ± 8.80 s RBZ vial 91.80 ± 17.69 s (p < 0.001) AFL vial 79.50 ± 14.22 s (p < 0.001) |
Lee 2022 [48] |
Survey |
AFL PFS AFL vial |
Ophthalmologists 78 |
Experiences using AFL PFS |
49/72 (68%) of respondents felt that more force was required to use AFL PFS plunger vs. traditional 1-ml syringes Common comments Lack of tactile feedback when pushing AFL PFS plunger Priming syringe difficult because of ambiguity in determining where to align the plunger tip |
Raevis 2022 [49] |
Letter to editor | AFL PFS | Not applicable | Author’s opinion | Reports of overdosing with PFS may be due to the syringe stopper deforming into the syringe dead space, allowing for more medication to be delivered |
AFL aflibercept, CI confidence interval, PFS prefilled syringe, RBZ ranibizumab