The Impact of Prefilled Syringes on Endophthalmitis Following Intravitreal Injection of Ranibizumab

Post-Injection Endophthalmitis (PIE) Study Group

Research output: Contribution to journalArticle

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Abstract

Purpose: To compare the rates of infectious endophthalmitis following intravitreal injection of ranibizumab using prefilled syringes vs conventional preparation. Design: Multicenter retrospective cohort study. Methods: All eyes receiving intravitreal injection of 0.5 mg ranibizumab for retinal vascular diseases at 10 retina practices across the United States (2016 to 2017) and Japan (2009 to 2017) were included. The total numbers of eyes and injections were determined from billing codes. Endophthalmitis cases were determined from billing records and evaluated with chart review. Primary outcome was the rate of postinjection acute endophthalmitis. Secondary outcomes were visual acuity and microbial spectrum. Results: A total of 243 754 intravitreal 0.5 mg ranibizumab injections (165 347 conventional and 78 407 prefilled) were administered to 43 132 unique patients during the study period. In the conventional ranibizumab group, a total of 43 cases of suspected endophthalmitis occurred (0.026%; 1 in 3845 injections) and 22 cases of culture-positive endophthalmitis occurred (0.013%; 1 in 7516 injections). In the prefilled ranibizumab group, 12 cases of suspected endophthalmitis occurred (0.015%; 1 in 6534 injections) and 2 cases of culture-positive endophthalmitis occurred (0.0026%; 1 in 39 204 injections). Prefilled syringes were associated with a trend toward decreased risk of suspected endophthalmitis (odds ratio 0.59; 95% confidence interval 0.31-1.12; P =.10) and a statistically significant decreased risk of culture-positive endophthalmitis (odds ratio 0.19; 95% confidence interval 0.045-0.82; P =.025). Average logMAR vision loss at final follow-up was significantly worse for eyes that developed endophthalmitis from the conventional ranibizumab preparation compared to the prefilled syringe group (4.45 lines lost from baseline acuity vs 0.38 lines lost; P =.0062). Oral-associated flora was found in 27.3% (6/22) of conventional ranibizumab culture-positive endophthalmitis cases (3 cases of Streptococcus viridans, 3 cases of Enterococcus faecalis) compared to 0 cases in the prefilled ranibizumab group. Conclusion: In a large, multicenter, retrospective study the use of prefilled syringes during intravitreal injection of ranibizumab was associated with a reduced rate of culture-positive endophthalmitis, including from oral flora, as well as with improved visual acuity outcomes.

Original languageEnglish
Pages (from-to)200-208
Number of pages9
JournalAmerican Journal of Ophthalmology
Volume199
DOIs
Publication statusPublished - Mar 1 2019

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Intravitreal Injections
Endophthalmitis
Syringes
Injections
Visual Acuity
Ranibizumab
Prefil
Retrospective Studies
Odds Ratio
Confidence Intervals
Viridans Streptococci
Retinal Diseases
Retinal Vessels
Enterococcus faecalis
Vascular Diseases
Multicenter Studies
Retina
Japan
Cohort Studies

ASJC Scopus subject areas

  • Ophthalmology

Cite this

The Impact of Prefilled Syringes on Endophthalmitis Following Intravitreal Injection of Ranibizumab. / Post-Injection Endophthalmitis (PIE) Study Group.

In: American Journal of Ophthalmology, Vol. 199, 01.03.2019, p. 200-208.

Research output: Contribution to journalArticle

Post-Injection Endophthalmitis (PIE) Study Group. / The Impact of Prefilled Syringes on Endophthalmitis Following Intravitreal Injection of Ranibizumab. In: American Journal of Ophthalmology. 2019 ; Vol. 199. pp. 200-208.
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abstract = "Purpose: To compare the rates of infectious endophthalmitis following intravitreal injection of ranibizumab using prefilled syringes vs conventional preparation. Design: Multicenter retrospective cohort study. Methods: All eyes receiving intravitreal injection of 0.5 mg ranibizumab for retinal vascular diseases at 10 retina practices across the United States (2016 to 2017) and Japan (2009 to 2017) were included. The total numbers of eyes and injections were determined from billing codes. Endophthalmitis cases were determined from billing records and evaluated with chart review. Primary outcome was the rate of postinjection acute endophthalmitis. Secondary outcomes were visual acuity and microbial spectrum. Results: A total of 243 754 intravitreal 0.5 mg ranibizumab injections (165 347 conventional and 78 407 prefilled) were administered to 43 132 unique patients during the study period. In the conventional ranibizumab group, a total of 43 cases of suspected endophthalmitis occurred (0.026{\%}; 1 in 3845 injections) and 22 cases of culture-positive endophthalmitis occurred (0.013{\%}; 1 in 7516 injections). In the prefilled ranibizumab group, 12 cases of suspected endophthalmitis occurred (0.015{\%}; 1 in 6534 injections) and 2 cases of culture-positive endophthalmitis occurred (0.0026{\%}; 1 in 39 204 injections). Prefilled syringes were associated with a trend toward decreased risk of suspected endophthalmitis (odds ratio 0.59; 95{\%} confidence interval 0.31-1.12; P =.10) and a statistically significant decreased risk of culture-positive endophthalmitis (odds ratio 0.19; 95{\%} confidence interval 0.045-0.82; P =.025). Average logMAR vision loss at final follow-up was significantly worse for eyes that developed endophthalmitis from the conventional ranibizumab preparation compared to the prefilled syringe group (4.45 lines lost from baseline acuity vs 0.38 lines lost; P =.0062). Oral-associated flora was found in 27.3{\%} (6/22) of conventional ranibizumab culture-positive endophthalmitis cases (3 cases of Streptococcus viridans, 3 cases of Enterococcus faecalis) compared to 0 cases in the prefilled ranibizumab group. Conclusion: In a large, multicenter, retrospective study the use of prefilled syringes during intravitreal injection of ranibizumab was associated with a reduced rate of culture-positive endophthalmitis, including from oral flora, as well as with improved visual acuity outcomes.",
author = "{Post-Injection Endophthalmitis (PIE) Study Group} and Storey, {Philip P.} and Zujaja Tauqeer and Yoshihiro Yonekawa and Bozho Todorich and Wolfe, {Jeremy D.} and Shah, {Sumit P.} and Shah, {Ankoor R.} and Takashi Koto and Abbey, {Ashkan M.} and Yuki Morizane and Priya Sharma and Wood, {Edward H.} and Mio Hosokawa and Pooja Pendri and Maitri Pancholy and Shawn Harkey and Jeng-Miller, {Karen W.} and Anthony Obeid and Borkar, {Durga S.} and Eric Chen and Patrick Williams and Okada, {Annabelle A.} and Makoto Inoue and Fumio Shiraga and Akito Hirakata and Shah, {Chirag P.} and Jonathan Prenner and Sunir Garg",
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T1 - The Impact of Prefilled Syringes on Endophthalmitis Following Intravitreal Injection of Ranibizumab

AU - Post-Injection Endophthalmitis (PIE) Study Group

AU - Storey, Philip P.

AU - Tauqeer, Zujaja

AU - Yonekawa, Yoshihiro

AU - Todorich, Bozho

AU - Wolfe, Jeremy D.

AU - Shah, Sumit P.

AU - Shah, Ankoor R.

AU - Koto, Takashi

AU - Abbey, Ashkan M.

AU - Morizane, Yuki

AU - Sharma, Priya

AU - Wood, Edward H.

AU - Hosokawa, Mio

AU - Pendri, Pooja

AU - Pancholy, Maitri

AU - Harkey, Shawn

AU - Jeng-Miller, Karen W.

AU - Obeid, Anthony

AU - Borkar, Durga S.

AU - Chen, Eric

AU - Williams, Patrick

AU - Okada, Annabelle A.

AU - Inoue, Makoto

AU - Shiraga, Fumio

AU - Hirakata, Akito

AU - Shah, Chirag P.

AU - Prenner, Jonathan

AU - Garg, Sunir

PY - 2019/3/1

Y1 - 2019/3/1

N2 - Purpose: To compare the rates of infectious endophthalmitis following intravitreal injection of ranibizumab using prefilled syringes vs conventional preparation. Design: Multicenter retrospective cohort study. Methods: All eyes receiving intravitreal injection of 0.5 mg ranibizumab for retinal vascular diseases at 10 retina practices across the United States (2016 to 2017) and Japan (2009 to 2017) were included. The total numbers of eyes and injections were determined from billing codes. Endophthalmitis cases were determined from billing records and evaluated with chart review. Primary outcome was the rate of postinjection acute endophthalmitis. Secondary outcomes were visual acuity and microbial spectrum. Results: A total of 243 754 intravitreal 0.5 mg ranibizumab injections (165 347 conventional and 78 407 prefilled) were administered to 43 132 unique patients during the study period. In the conventional ranibizumab group, a total of 43 cases of suspected endophthalmitis occurred (0.026%; 1 in 3845 injections) and 22 cases of culture-positive endophthalmitis occurred (0.013%; 1 in 7516 injections). In the prefilled ranibizumab group, 12 cases of suspected endophthalmitis occurred (0.015%; 1 in 6534 injections) and 2 cases of culture-positive endophthalmitis occurred (0.0026%; 1 in 39 204 injections). Prefilled syringes were associated with a trend toward decreased risk of suspected endophthalmitis (odds ratio 0.59; 95% confidence interval 0.31-1.12; P =.10) and a statistically significant decreased risk of culture-positive endophthalmitis (odds ratio 0.19; 95% confidence interval 0.045-0.82; P =.025). Average logMAR vision loss at final follow-up was significantly worse for eyes that developed endophthalmitis from the conventional ranibizumab preparation compared to the prefilled syringe group (4.45 lines lost from baseline acuity vs 0.38 lines lost; P =.0062). Oral-associated flora was found in 27.3% (6/22) of conventional ranibizumab culture-positive endophthalmitis cases (3 cases of Streptococcus viridans, 3 cases of Enterococcus faecalis) compared to 0 cases in the prefilled ranibizumab group. Conclusion: In a large, multicenter, retrospective study the use of prefilled syringes during intravitreal injection of ranibizumab was associated with a reduced rate of culture-positive endophthalmitis, including from oral flora, as well as with improved visual acuity outcomes.

AB - Purpose: To compare the rates of infectious endophthalmitis following intravitreal injection of ranibizumab using prefilled syringes vs conventional preparation. Design: Multicenter retrospective cohort study. Methods: All eyes receiving intravitreal injection of 0.5 mg ranibizumab for retinal vascular diseases at 10 retina practices across the United States (2016 to 2017) and Japan (2009 to 2017) were included. The total numbers of eyes and injections were determined from billing codes. Endophthalmitis cases were determined from billing records and evaluated with chart review. Primary outcome was the rate of postinjection acute endophthalmitis. Secondary outcomes were visual acuity and microbial spectrum. Results: A total of 243 754 intravitreal 0.5 mg ranibizumab injections (165 347 conventional and 78 407 prefilled) were administered to 43 132 unique patients during the study period. In the conventional ranibizumab group, a total of 43 cases of suspected endophthalmitis occurred (0.026%; 1 in 3845 injections) and 22 cases of culture-positive endophthalmitis occurred (0.013%; 1 in 7516 injections). In the prefilled ranibizumab group, 12 cases of suspected endophthalmitis occurred (0.015%; 1 in 6534 injections) and 2 cases of culture-positive endophthalmitis occurred (0.0026%; 1 in 39 204 injections). Prefilled syringes were associated with a trend toward decreased risk of suspected endophthalmitis (odds ratio 0.59; 95% confidence interval 0.31-1.12; P =.10) and a statistically significant decreased risk of culture-positive endophthalmitis (odds ratio 0.19; 95% confidence interval 0.045-0.82; P =.025). Average logMAR vision loss at final follow-up was significantly worse for eyes that developed endophthalmitis from the conventional ranibizumab preparation compared to the prefilled syringe group (4.45 lines lost from baseline acuity vs 0.38 lines lost; P =.0062). Oral-associated flora was found in 27.3% (6/22) of conventional ranibizumab culture-positive endophthalmitis cases (3 cases of Streptococcus viridans, 3 cases of Enterococcus faecalis) compared to 0 cases in the prefilled ranibizumab group. Conclusion: In a large, multicenter, retrospective study the use of prefilled syringes during intravitreal injection of ranibizumab was associated with a reduced rate of culture-positive endophthalmitis, including from oral flora, as well as with improved visual acuity outcomes.

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