A Randomized, Prospective Clinical Comparison of the Efficacy and Safety of Topical Fluoroquinolone Antibiotics in Ophthalmologic Microsurgery

Myung Jun Kim; Jun Hun Lee; Young Ran Yoon; Hong Kyun Kim

doi:10.3341/jkos.2011.52.12.1440

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Kim, Lee, Yoon, and Kim: A Randomized, Prospective Clinical Comparison of the Efficacy and Safety of Topical Fluoroquinolone Antibiotics in Ophthalmologic Microsurgery

Original Article

J Korean Ophthalmol Soc 2011;52(12):1440-1447.

Published online: 7 September 2011

DOI: https://doi.org/10.3341/jkos.2011.52.12.1440

A Randomized, Prospective Clinical Comparison of the Efficacy and Safety of Topical Fluoroquinolone Antibiotics in Ophthalmologic Microsurgery

Myung Jun Kim, MD¹, Jun Hun Lee, MD¹, Young Ran Yoon, MD, PhD², Hong Kyun Kim, MD, PhD¹

¹Department of Ophthalmology, Kyungpook National University School of Medicine, Daegu, Korea

²epartment of Molecular Medicine, Kyungpook National University School of Medicine and Clinical Trial Center of Kyungpook National University Hospital, Daegu, Korea

Address reprint requests to Hong Kyun Kim, MD, PhD Department of Ophthalmology, Kyungpook National University Hospital #130 Dongdeok-ro, Jung-gu, Daegu 700-721, Korea Tel: 82-53-420-5806, Fax: 82-53-426-6552, E-mail: okeye@hanmir.com

Received 4 March 201116 August 2011 Accepted 29 October 2011

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

To report the results of a clinical comparison study of a prophylactic new generation fluoroquinolone (FQs; levofloxacin 0.5%, gatifloxacin 0.3% and moxifloxacin 0.5%) topical antibiotic regimen administered prior to intraocular microsurgery.

Methods

From May 2007 to April 2010, Trial 1, 214 eyes of 211 patients scheduled for intravitreal injection were randomized into one of three FQ-treated groups or the control (non-treated) group. Patients who were randomized into FQ-treated groups were treated with eye drops containing one of three FQ antibiotics (levofloxacin 0.5%, gatifloxacin 0.3% and moxifloxacin 0.5%) preoperatively four times a day for three days before surgery. The rate of positive bacterial cultures from conjunctival scrapings were assessed and compared. Trial 2, 159 eyes of 159 patients scheduled for cataract surgery were randomized into one of three FQ-treated groups, and treated with eye drops as same method in trial 1. The concentration of antibiotics in the anterior chamber of the eye were measured and compared.

Results

The positive bacterial culture rates of trial 1 were 48.9%, 38.3%, 23.4% in the levofloxacin-treated group, the gati-floxacin-group, and the moxifloxacin-treated group, respectively. These rates were all significantly lower than the 70.2% positivity rate observed in the control group. Average antibiotic residue concentrations in the aqueous humor measured in trial 2 were 0.37 ± 0.49 μ g/ml in the levofloxacin-treated group, 0.31 ± 0.37 μ g/ml in the gatifloxacin-treated group and 0.59 ± 0.72 μ g/ml in the moxifloxacin-treated group. These concentrations were not significantly different. There were no reported side effects during the study period.

Conclusions

Eye drops containing new generation FQ antibiotics instilled three days before microscopic ophthalmic surgery can be used safely and effectively for the prevention of postoperative endophthalmitis.

Keywords: Clinical trial, Fluoroquinolone antibiotics, Postoperative endophthalmitis, Prevention, Safety

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Figure 1.

Schematic flow diagram of clinical trial 1.

Figure 2.

Schematic flow diagram of clinical trial 2.

Figure 3.

Comparison of residual concentration of antibiotics in the aqueous humor.

Table 1.

Thedetected pathogens of each antibiotics treatment and contol groups

	n	MS CNS	MR CNS	S. epidermidis	S. pneumoniae	S. aureus	Haemophilus species.	etc	Total	Culture rate (%)
Levofloxacin	45	3	12	0	0	1	2	4	22	48.9
Gatifloxacin	47	4	7	5	0	0	0	2	18	38.3
Moxifloxacin	47	1	3	2	0	0	1	4	11	23.4
Control	47	12	10	4	1	1	1	4	33	70.2
Total	186	20	32	11	1	2	4	14	84	45.2

MS-CNS = methicillin-sensitive coagulase negative staphylococci; MR-CNS = methicillin-resistant CNS; S. epidermidis = Staphylococcus epidermidis; S. pneumonia = Staphylococcus pneumonia; S. aureus = Staphylococcus aureus.

Table 2.

Residual concentration of antibiotics in the aqueous humor of cataract operation-performed patients

	n	Residual concentration (μ g/ml)	STD (μ g/ml)	F-value	p-value
Levofloxacin	46	0.37	0.49	2.827	0.064
Gatifloxacin	48	0.31	0.37
Moxifloxacin	48	0.59	0.72
Total	142	0.42	0.55

1 Statistical significances were tested by oneway analysis of variances among groups.

STD = standard deviation.

Table 3.

Descriptive statistics of MICs (μ g/ml) of 3 fluoroquinolones for the conjunctival bacteria isolated (Hori et al²⁵)

Organism	Median	MIC₅₀	MIC₉₀	Mode	MIC range
CNS (total)
Levofloxacin	0.50	0.50	8	0.50, 8	0.25-128.0
Gatifloxacin	0.25	0.25	4	0.25	<0.06-32.0
Moxifloxacin	0.25	0.25	4	0.25	<0.06-64.0
MS-CNS
Levofloxacin	0.50	0.50	8	0.50	0.25-128.0
Gatifloxacin	0.25	0.25	4	0.25	<0.06-32.0
Moxifloxacin	0.25	0.25	2	0.25	0.13-64.0
MR-CNS
Levofloxacin	8	8	8	8	<0.06-64.0
Gatifloxacin	3	2	4	4	<0.06-8.0
Moxifloxacin	2	2	4	2	<0.06-16.0
Corynebacterium
Levofloxacin	0.50	0.50	128	0.13	<0.06-128.0
Gatifloxacin	0.25	0.25	32	0.06	<0.06-64.0
Moxifloxacin	0.25	0.25	64	0.06	<0.06-128.0
P. acnes
Levofloxacin	0.25	0.25	0.50	0.25	<0.06-1.0
Gatifloxacin	0.13	0.13	0.25	0.13	<0.06-1.0
Moxifloxacin	0.13	0.13	0.25	0.13	<0.06-0.5

MIC = minimum inhibitory concentration; CNS = coagulase-negative Staphylococcus; MS-CNS = methicillin-sensitive coagulase negative staphylococci; MR-CNS = methicillin-resistant CNS; P. acnes = Propionibacterium acnes.

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