A prospective multicentre randomized placebo-controlled superiority trial in patients with suspected bacterial endophthalmitis after cataract surgery on the adjuvant use of intravitreal dexamethasone to intravitreal antibiotics

Sonia Manning; Luana C Ugahary; Eric W Lindstedt; René J Wubbels; Jaap T van Dissel; Jan T G Jansen; Ivan Gan; Arnoud T van Goor; Carlien A Bennebroek; Dymph J van der Werf; Annette Ossewaarde-van Norel; Chris C Mayland Nielsen; Mauk Tilanus; Pieter R van den Biesen; Peter A Schellekens; Ellen La Heij; Koorosh Faridpooya; Koen van Overdam; Marc Veckeneer; Jan C van Meurs

doi:10.1111/aos.13610

A prospective multicentre randomized placebo-controlled superiority trial in patients with suspected bacterial endophthalmitis after cataract surgery on the adjuvant use of intravitreal dexamethasone to intravitreal antibiotics

Sonia Manning, Luana C Ugahary, Eric W Lindstedt, René J Wubbels, Jaap T van Dissel, Jan T G Jansen, Ivan Gan, Arnoud T van Goor, Carlien A Bennebroek, Dymph J van der Werf, Annette Ossewaarde-van Norel, Chris C Mayland Nielsen, Mauk Tilanus, Pieter R van den Biesen, Peter A Schellekens, Ellen La Heij, Koorosh Faridpooya, Koen van Overdam, Marc Veckeneer, Jan C van Meurs

Research output: Contribution to journal › Article › Research › peer-review

Abstract

PURPOSE: We aimed to determine whether intravitreal dexamethasone as an adjuvant to intravitreal antibiotics is beneficial in the treatment of suspected bacterial endophthalmitis after cataract surgery.

METHODS: Randomized, placebo-controlled superiority trial in three tertiary referral centres in the Netherlands. Patients with suspected bacterial endophthalmitis within 6 weeks after cataract surgery were eligible. A diagnostic vitreous biopsy was taken for culture, and patients received intravitreal injections of 400 μg dexamethasone (without preservatives) or placebo, in addition to 0.2 mg vancomycin and 0.05 mg gentamicin. The vancomycin and dexamethasone or placebo injections were repeated once at day 3 or 4. Primary outcome measure was best-corrected visual acuity (BCVA) at 1 year.

RESULTS: Between 1 November 2004 and 1 March 2014 (excluding two interruptions totalling 20 months), 324 eligible patients presented. A total of 167 patients (81 dexamethasone, 86 placebo) were available for the intention-to-treat analysis. Biopsies of 114 patients (68%) were culture-positive. Final BCVA did not differ between the dexamethasone and the placebo group (logMAR 0.31 ± 0.58 versus 0.27 ± 0.50; p = 0.90), nor did the number of patients with final vision of no light perception (LP, 7 versus 13). Pain, corneal oedema, the absence of a red fundus reflex on presentation, LP on presentation and culture of virulent pathogens from biopsy were statistically significantly associated with an unfavourable visual outcome.

CONCLUSION: Intravitreal dexamethasone without preservatives as an adjuvant to intravitreal antibiotics does not improve visual acuity (VA) in patients treated for suspected bacterial endophthalmitis after cataract surgery.

Original language	English
Pages (from-to)	348-355
Number of pages	8
Journal	Acta Ophthalmologica
Volume	96
Issue number	4
DOIs	https://doi.org/10.1111/aos.13610
Publication status	Published - Jun 2018

Keywords

Aged
Anti-Bacterial Agents/administration & dosage
Cataract Extraction/adverse effects
Dexamethasone/administration & dosage
Endophthalmitis/drug therapy
Eye Infections, Bacterial/etiology
Female
Follow-Up Studies
Gentamicins/administration & dosage
Glucocorticoids/administration & dosage
Humans
Intravitreal Injections
Male
Prospective Studies
Surgical Wound Infection/drug therapy
Treatment Outcome
Vancomycin/administration & dosage
Visual Acuity

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Manning, S., Ugahary, L. C., Lindstedt, E. W., Wubbels, R. J., van Dissel, J. T., Jansen, J. T. G., Gan, I., van Goor, A. T., Bennebroek, C. A., van der Werf, D. J., Ossewaarde-van Norel, A., Mayland Nielsen, C. C., Tilanus, M., van den Biesen, P. R., Schellekens, P. A., La Heij, E., Faridpooya, K., van Overdam, K., Veckeneer, M., & van Meurs, J. C. (2018). A prospective multicentre randomized placebo-controlled superiority trial in patients with suspected bacterial endophthalmitis after cataract surgery on the adjuvant use of intravitreal dexamethasone to intravitreal antibiotics. Acta Ophthalmologica, 96(4), 348-355. https://doi.org/10.1111/aos.13610

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title = "A prospective multicentre randomized placebo-controlled superiority trial in patients with suspected bacterial endophthalmitis after cataract surgery on the adjuvant use of intravitreal dexamethasone to intravitreal antibiotics",

abstract = "PURPOSE: We aimed to determine whether intravitreal dexamethasone as an adjuvant to intravitreal antibiotics is beneficial in the treatment of suspected bacterial endophthalmitis after cataract surgery.METHODS: Randomized, placebo-controlled superiority trial in three tertiary referral centres in the Netherlands. Patients with suspected bacterial endophthalmitis within 6 weeks after cataract surgery were eligible. A diagnostic vitreous biopsy was taken for culture, and patients received intravitreal injections of 400 μg dexamethasone (without preservatives) or placebo, in addition to 0.2 mg vancomycin and 0.05 mg gentamicin. The vancomycin and dexamethasone or placebo injections were repeated once at day 3 or 4. Primary outcome measure was best-corrected visual acuity (BCVA) at 1 year.RESULTS: Between 1 November 2004 and 1 March 2014 (excluding two interruptions totalling 20 months), 324 eligible patients presented. A total of 167 patients (81 dexamethasone, 86 placebo) were available for the intention-to-treat analysis. Biopsies of 114 patients (68%) were culture-positive. Final BCVA did not differ between the dexamethasone and the placebo group (logMAR 0.31 ± 0.58 versus 0.27 ± 0.50; p = 0.90), nor did the number of patients with final vision of no light perception (LP, 7 versus 13). Pain, corneal oedema, the absence of a red fundus reflex on presentation, LP on presentation and culture of virulent pathogens from biopsy were statistically significantly associated with an unfavourable visual outcome.CONCLUSION: Intravitreal dexamethasone without preservatives as an adjuvant to intravitreal antibiotics does not improve visual acuity (VA) in patients treated for suspected bacterial endophthalmitis after cataract surgery.",

keywords = "Aged, Anti-Bacterial Agents/administration & dosage, Cataract Extraction/adverse effects, Dexamethasone/administration & dosage, Endophthalmitis/drug therapy, Eye Infections, Bacterial/etiology, Female, Follow-Up Studies, Gentamicins/administration & dosage, Glucocorticoids/administration & dosage, Humans, Intravitreal Injections, Male, Prospective Studies, Surgical Wound Infection/drug therapy, Treatment Outcome, Vancomycin/administration & dosage, Visual Acuity",

author = "Sonia Manning and Ugahary, {Luana C} and Lindstedt, {Eric W} and Wubbels, {Ren{\'e} J} and {van Dissel}, {Jaap T} and Jansen, {Jan T G} and Ivan Gan and {van Goor}, {Arnoud T} and Bennebroek, {Carlien A} and {van der Werf}, {Dymph J} and {Ossewaarde-van Norel}, Annette and {Mayland Nielsen}, {Chris C} and Mauk Tilanus and {van den Biesen}, {Pieter R} and Schellekens, {Peter A} and {La Heij}, Ellen and Koorosh Faridpooya and {van Overdam}, Koen and Marc Veckeneer and {van Meurs}, {Jan C}",

note = "{\textcopyright} 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.",

year = "2018",

month = jun,

doi = "10.1111/aos.13610",

language = "English",

volume = "96",

pages = "348--355",

number = "4",

}

Manning, S , Ugahary, LC, Lindstedt, EW, Wubbels, RJ, van Dissel, JT, Jansen, JTG, Gan, I , van Goor, AT, Bennebroek, CA, van der Werf, DJ, Ossewaarde-van Norel, A, Mayland Nielsen, CC, Tilanus, M, van den Biesen, PR, Schellekens, PA, La Heij, E, Faridpooya, K , van Overdam, K, Veckeneer, M & van Meurs, JC 2018, 'A prospective multicentre randomized placebo-controlled superiority trial in patients with suspected bacterial endophthalmitis after cataract surgery on the adjuvant use of intravitreal dexamethasone to intravitreal antibiotics', Acta Ophthalmologica, vol. 96, no. 4, pp. 348-355. https://doi.org/10.1111/aos.13610

A prospective multicentre randomized placebo-controlled superiority trial in patients with suspected bacterial endophthalmitis after cataract surgery on the adjuvant use of intravitreal dexamethasone to intravitreal antibiotics. / Manning, Sonia ; Ugahary, Luana C; Lindstedt, Eric W et al.
In: Acta Ophthalmologica, Vol. 96, No. 4, 06.2018, p. 348-355.

Research output: Contribution to journal › Article › Research › peer-review

TY - JOUR

T1 - A prospective multicentre randomized placebo-controlled superiority trial in patients with suspected bacterial endophthalmitis after cataract surgery on the adjuvant use of intravitreal dexamethasone to intravitreal antibiotics

AU - Manning, Sonia

AU - Ugahary, Luana C

AU - Lindstedt, Eric W

AU - Wubbels, René J

AU - van Dissel, Jaap T

AU - Jansen, Jan T G

AU - Gan, Ivan

AU - van Goor, Arnoud T

AU - Bennebroek, Carlien A

AU - van der Werf, Dymph J

AU - Ossewaarde-van Norel, Annette

AU - Mayland Nielsen, Chris C

AU - Tilanus, Mauk

AU - van den Biesen, Pieter R

AU - Schellekens, Peter A

AU - La Heij, Ellen

AU - Faridpooya, Koorosh

AU - van Overdam, Koen

AU - Veckeneer, Marc

AU - van Meurs, Jan C

PY - 2018/6

Y1 - 2018/6

N2 - PURPOSE: We aimed to determine whether intravitreal dexamethasone as an adjuvant to intravitreal antibiotics is beneficial in the treatment of suspected bacterial endophthalmitis after cataract surgery.METHODS: Randomized, placebo-controlled superiority trial in three tertiary referral centres in the Netherlands. Patients with suspected bacterial endophthalmitis within 6 weeks after cataract surgery were eligible. A diagnostic vitreous biopsy was taken for culture, and patients received intravitreal injections of 400 μg dexamethasone (without preservatives) or placebo, in addition to 0.2 mg vancomycin and 0.05 mg gentamicin. The vancomycin and dexamethasone or placebo injections were repeated once at day 3 or 4. Primary outcome measure was best-corrected visual acuity (BCVA) at 1 year.RESULTS: Between 1 November 2004 and 1 March 2014 (excluding two interruptions totalling 20 months), 324 eligible patients presented. A total of 167 patients (81 dexamethasone, 86 placebo) were available for the intention-to-treat analysis. Biopsies of 114 patients (68%) were culture-positive. Final BCVA did not differ between the dexamethasone and the placebo group (logMAR 0.31 ± 0.58 versus 0.27 ± 0.50; p = 0.90), nor did the number of patients with final vision of no light perception (LP, 7 versus 13). Pain, corneal oedema, the absence of a red fundus reflex on presentation, LP on presentation and culture of virulent pathogens from biopsy were statistically significantly associated with an unfavourable visual outcome.CONCLUSION: Intravitreal dexamethasone without preservatives as an adjuvant to intravitreal antibiotics does not improve visual acuity (VA) in patients treated for suspected bacterial endophthalmitis after cataract surgery.

AB - PURPOSE: We aimed to determine whether intravitreal dexamethasone as an adjuvant to intravitreal antibiotics is beneficial in the treatment of suspected bacterial endophthalmitis after cataract surgery.METHODS: Randomized, placebo-controlled superiority trial in three tertiary referral centres in the Netherlands. Patients with suspected bacterial endophthalmitis within 6 weeks after cataract surgery were eligible. A diagnostic vitreous biopsy was taken for culture, and patients received intravitreal injections of 400 μg dexamethasone (without preservatives) or placebo, in addition to 0.2 mg vancomycin and 0.05 mg gentamicin. The vancomycin and dexamethasone or placebo injections were repeated once at day 3 or 4. Primary outcome measure was best-corrected visual acuity (BCVA) at 1 year.RESULTS: Between 1 November 2004 and 1 March 2014 (excluding two interruptions totalling 20 months), 324 eligible patients presented. A total of 167 patients (81 dexamethasone, 86 placebo) were available for the intention-to-treat analysis. Biopsies of 114 patients (68%) were culture-positive. Final BCVA did not differ between the dexamethasone and the placebo group (logMAR 0.31 ± 0.58 versus 0.27 ± 0.50; p = 0.90), nor did the number of patients with final vision of no light perception (LP, 7 versus 13). Pain, corneal oedema, the absence of a red fundus reflex on presentation, LP on presentation and culture of virulent pathogens from biopsy were statistically significantly associated with an unfavourable visual outcome.CONCLUSION: Intravitreal dexamethasone without preservatives as an adjuvant to intravitreal antibiotics does not improve visual acuity (VA) in patients treated for suspected bacterial endophthalmitis after cataract surgery.

KW - Aged

KW - Anti-Bacterial Agents/administration & dosage

KW - Cataract Extraction/adverse effects

KW - Dexamethasone/administration & dosage

KW - Endophthalmitis/drug therapy

KW - Eye Infections, Bacterial/etiology

KW - Female

KW - Follow-Up Studies

KW - Gentamicins/administration & dosage

KW - Glucocorticoids/administration & dosage

KW - Humans

KW - Intravitreal Injections

KW - Male

KW - Prospective Studies

KW - Surgical Wound Infection/drug therapy

KW - Treatment Outcome

KW - Vancomycin/administration & dosage

KW - Visual Acuity

U2 - 10.1111/aos.13610

DO - 10.1111/aos.13610

M3 - Article

C2 - 29214740

SN - 1755-375X

VL - 96

SP - 348

EP - 355

JO - Acta Ophthalmologica

JF - Acta Ophthalmologica

IS - 4

ER -

Manning S , Ugahary LC, Lindstedt EW, Wubbels RJ, van Dissel JT, Jansen JTG et al. A prospective multicentre randomized placebo-controlled superiority trial in patients with suspected bacterial endophthalmitis after cataract surgery on the adjuvant use of intravitreal dexamethasone to intravitreal antibiotics. Acta Ophthalmologica. 2018 Jun;96(4):348-355. doi: 10.1111/aos.13610