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DOI: 10.5301/ejo.

5000093

Eur J Ophthalmol 2012 ; 22 ( 4 ): 541-546

ORIGINAL ARTICLE

free on line

Application of 10% povidone iodine reduces


conjunctival bacterial contamination rate in patients
undergoing cataract surgery
Martin M. Nentwich1, Mohammed Rajab1, Christopher N. Ta2, Lisa He2, Martin Grueterich1,
Christos Haritoglou1, Arnd Gandorfer1, Anselm Kampik1, Herminia Mino De Kaspar1,2
1
2

Department of Ophthalmology, Ludwig-Maximilians-University, Munich - Germany


Department of Ophthalmology, School of Medicine, Stanford University, Stanford, California - USA

Department of Ophthalmology, Ludwig-Maximilians-University, Munich - Germany


Department of Ophthalmology, School of Medicine, Stanford University, Stanford, California - USA
Department of Ophthalmology, Ludwig-Maximilians-University, Munich - Germany
Department of Ophthalmology, Ludwig-Maximilians-University, Munich - Germany
Department of Ophthalmology, Ludwig-Maximilians-University, Munich - Germany
Department of Ophthalmology, Ludwig-Maximilians-University, Munich - Germany; Department of Ophthalmology, School of Medicine, Stanford University, Stanford, California - USA
Department of Ophthalmology, Ludwig-Maximilians-University, Munich - Germany

PURPOSE. To determine the efficacy of 10% povidone iodine (PVI) drops given before cataract extraction in addition to routine irrigation of the conjunctival sac with 1% PVI.
METHODS. This prospective, randomized, single-center study at the Department of Ophthalmology,
Ludwig-Maximilians-University, Munich, includes 263 eyes of 242 patients undergoing cataract surgery. Patients were randomized to receive 3 drops of 10% PVI into the conjunctival sac (study group)
or no PVI drops (control group). All patients underwent periorbital disinfection with 10% PVI followed
by irrigation of the conjunctiva with 10 mL of 1% PVI. Specimens were obtained prior to the application of PVI, after antibiotic administration (T1), after irrigation with PVI but before surgery (T2), and at
the conclusion of surgery (T3).
RESULTS. After PVI disinfection, the number of positive cultures was significantly reduced in all groups
(p<0.0001) from 69%-93% at T1 to 1%-16% at T3. In outpatients, the study group showed significantly fewer positive cultures at the conclusion of surgery compared to the control group (4% vs 16%;
p=0.03). Also in inpatients significant fewer positive cultures were found in the study group compared
to the control group at T2 (12% vs 28%; p=0.03) and at T3 (1% vs 10%; p=0.03).
CONCLUSIONS. Three additional drops of 10% PVI prior to surgery provided additional benefit by reducing the conjunctival bacterial contamination rate even in the setting of preoperative irrigation of the
conjunctiva with 1% PVI.
Key Words. Cataract surgery, Conjunctival flora, Microbiology, Povidone iodine, Preoperative prophylaxis
Accepted: November 14, 2011

INTRODUCTION
Postoperative endophthalmitis is one of the most serious
complications of cataract surgery and may lead to severe
visual loss. The prevalence of postoperative endophthalmitis following cataract surgery is 0.06% to 0.68% (1).
A meta-analysis by Taban et al showed a significant increase in postoperative endophthalmitis from 0.087% in
the 1990s to 0.265% for the 2000-2003 period (2). This upward trend in the prevalence of postoperative endophthal-

mitis coincides with the increasing popularity of sutureless


clear-cornea cataract surgery.
The patients own conjunctiva, eyelid, and nose are considered to be the main sources of bacteria causing infection (3, 4). It has been shown that a certain number of inoculated bacteria is necessary to overcoming host defense
mechanisms for the development of fulminant postoperative endophthalmitis. Therefore, preoperative reduction of
the conjunctival bacterial load may be beneficial in the prevention of infection (5).

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10% Povidone iodine as prophylaxis before cataract surgery

Fig. 1 - Outline of the infection prophylaxis regimen. The individual steps in the preoperative infection prophylaxis regimen are illustrated. The
difference between the control and the study groups is shown in light gray. PVI = povidone iodine.

Povidone-iodine (PVI) antisepsis has proven to reduce


the risk of endophthalmitis following cataract surgery (6).
Due to the low prevalence of these cases, a prospective
randomized study evaluating the efficacy of any prophylactic measure to reduce the actual risk of postoperative
endophthalmitis would require a very large number of patients and is impractical to perfom.
In the current study, we compare 2 different methods of
preoperative application of PVI. The goal of this study was
to determine whether 10% PVI drops applied to the conjunctival sac followed by irrigation of the conjunctival sac
with 1% PVI is superior in reducing conjunctival bacterial
contamination rate compared to 1% PVI irrigation alone.

MATERIALS AND METHODS


Consecutive patients undergoing cataract surgery were enrolled in this prospective study. All surgeries were performed
at the Department of Ophthalmology, Ludwig-MaximiliansUniversity Munich from July to December 2008. The study
was approved by the Institutional Review Board of LudwigMaximilians-University, Munich. Informed consent was obtained from all patients prior to enrollment in the study.
In Germany, patients with significant medical illness such as
severe hypertension, poorly controlled diabetes mellitus, or
a history of stroke or myocardial infarction may be admitted
to hospital the day prior to cataract surgery. Because of the
difference in preoperative antibiotics regimen, patients were
542

stratified to outpatient and inpatient groups. All 112 eyes of


outpatients received one drop of topical neomycin (Alcon
Pharma, Freiburg, Germany) the hour prior to surgery while
151 eyes of inpatients received one drop of topical neomycin
4 times daily on the day prior to surgery and one drop in the
morning on the day of surgery. If surgery was scheduled in
the afternoon, the patients received a second drop of topical
neomycin before being transferred to the operating room.
Patients were randomized to the control and study groups.
In the preoperative area, the patients in the study group
received 3 drops of 10% PVI (Braunol; B. Braun, Melsungen, Germany) in the conjunctival sac (in a single application) while the control group received none. Afterwards,
all patients of both groups underwent standard periorbital
disinfection using 10% PVI scrub on the eyelids and surrounding skin followed by application of gauze soaked
with 10% PVI on the closed lids for 5 minutes. After the
patient had been transferred into the operating room, the
conjunctival sac was vigorously irrigated with 10 mL of
1% povidone iodine solution in both groups. Next, the
brow, upper and lower eyelids, eyelashes, and the adjacent forehead, nose, cheeks, and temporal orbital area
were again scrubbed with 10% PVI just prior to surgery.
The incubation time was identical in both groups to avoid
any confounding factor in this respect. Figure 1 summarizes the infection prophylaxis regimen.
Conjunctival specimens from the surgery eyes were obtained at the following time points: T1, prior to the application
of PVI but after the administration of topical neomycin antibi-

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Nentwich et al

Fig. 2 - Positive cultures in outpatients: control group vs study


group. The percentage of positive cultures in the control and the
study group is shown at the different timepoints (T1-T3) for the outpatient group. The asterisk (*) indicates a statistically significant difference between the groups.

Fig. 3 - Positive cultures in inpatients: control group vs study group.


The percentage of positive cultures in the control and the study
group is shown at the different timepoints (T1-T3) for the inpatient
group. The asterisk (*) indicates a statistically significant difference
between the groups.

TABLE I - POSITIVE CULTURES FROM THIOGLYCOLATE BROTH


Outpatients (no. of eyes = 112)

Inpatients (no. of eyes = 151)

Control group (n=57)

Study group (n=55)

Control group (n=74)

Study group (n=77)

T1

92.7% (51)

86.0% (49)

69.0% (49)

85.5% (76)

T2

28.8% (17)

16.4% (9)

28.0% (20)

11.7% (9)

T3

15.8% (9)

3.7% (2)

9.6% (7)

1.3% (1)

otics; T2, following all the different applications of PVI, just prior to surgery; T3, at the conclusion of surgery. All specimens
were obtained by the surgeon in masked fashion. The specimens were inoculated and incubated in thioglycolate broth at
37C for 5 days. The microbiologist who interpreted the culture results was masked with regard to the patient group. In
all positive cultures, bacteria were isolated (first on blood agar
[Columbia agar with 5% sheep blood], MacConkey agar, and
on agar chromID-CPS3 agar), identified and tested for antibiotic susceptibility with Vitek2 Compact System (all materials
were obtained from bioMerieux, Marcy lEtoile, France), and
the results compared between the groups. Cross tab analysis
using chi-square test (SPSS for Windows, SPSS Inc., Chicago, Illinois, USA) was performed to determine statistically
significant differences between the groups.

RESULTS
In all patients, there was significant reduction (p<0.0001) in
the number of positive cultures comparing T1 and T2, fol-

lowing the application of PVI. For the outpatient group, there


was no difference at baseline (T1) cultures between the control group and the study group (p=0.25). There was a trend
in fewer positive cultures for the study group (17%) compared to the control group (29%) following the application of
PVI (T2), but this was not statistically significant (p=0.1). At
the conclusion of surgery (T3), the study group had significantly fewer positive cultures compared to the control group
(p=0.03); specifically, a fourfold difference (4% versus 16%).
For the inpatient group, the study group had a higher initial
(T1) positive culture result compared to the control group,
86% versus 69%, respectively (p=0.01). However, following
the application of PVI, the study group had a significantly
lower positive culture rate compared to the control group
(12% versus 28%) (p=0.01). The patients in the study group
continue to have a lower culture-positive rate at the conclusion of surgery, 1% versus 10% (p=0.03). Table I and Figures 2 and 3 summarize the results. Table II shows the p
value comparing different patient groups.
Bacteria isolated from the conjunctiva prior to PVI application, in decreasing frequency, were coagulase-negative

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10% Povidone iodine as prophylaxis before cataract surgery

Staphylococcus 101/147 (68.7%), followed by Propionibacterium acnes 26/147 (17.7%), -hemolytic Streptococcus 7/147 (4.8%), Staphylococcus aureus 6/147 (4.1%),
Enterococcus faecalis 4/147 (2.6%), Micrococcus sp
1/147 (0.7%), -hemolytic Streptococcus 1/147 (0.7%),
and Aerococcus urinae 1/147 (0.7%). There was no case of

endophthalmitis. Table III demonstrates the distribution of


bacteria in the 2 patient groups at the different timepoints.
There was no obvious intraoperative and postoperative
toxicity from PVI, but the current study was not designed
to assess toxicity of PVI.

TABLE II - p VALUES (CHI-SQUARE TEST)


Outpatients

T1 vs T2

Inpatients

Control group

Study group

Control group

Study group

<0.0001

<0.0001

<0.0001

<0.0001

T2 vs T3

0.0926

0.0282

0.0043

0.0094

T1 vs T3

<0.0001

<0.0001

<0.0001

<0.0001

Control group vs study group

Control group vs study group

T1

0.2474

0.0128

T2

0.1134

0.0116

T3

0.0332

0.0251

TABLE III - DISTRIBUTION OF BACTERIA


T1

T2

T3

Total

Study group
Bacterial distribution
CNS

53

64

Staphylococcus aureus

-Hemolytic Streptococcus

-Hemolytic Streptococcus

Propionibacterium acnes

12

14

Micrococcus sp

Enterococcus faecalis

Aerococcus urinae

Total

75

12

89

48

15

70

14

19

72

27

108

Control group
Bacterial distribution
CNS
Staphylococcus aureus
-Hemolytic Streptococcus
-Hemolytic Streptococcus
Propionibacterium acnes
Micrococcus sp
Enterococcus faecalis
Aerococcus urinae
Total

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Nentwich et al

DISCUSSION
We performed this study in order to evaluate whether the
additional application of 3 drops of 10% PVI directly into
the conjunctival sac would reduce the conjunctival bacterial contamination rate to a greater extent than the scrubbing of the eyelids and periorbital area with 10% PVI and
irrigation with 1% PVI. Our study of 263 eyes demonstrated that the addition of 3 drops of 10% PVI to the conjunctival sac further reduced the rate of conjunctival cultures in
the perioperative period compared to 10% PVI periorbital
scrub and 1% PVI irrigation of the conjunctiva. This reduction was statistically significant at the conclusion of surgery
for the outpatient group. For the inpatient group, the study
group had significantly lower conjunctiva culture rate than
the control group following the application of PVI just prior
to surgery and at the conclusion of surgery. The incubation
time of PVI was identical in both groups to avoid any confounding factor in this respect. The safety of 10% PVI used
in the periorbital area has been described previously as
well as the use of 5% PVI on the ocular surface itself (7-12).
The bacteria identified at T1, which is after preoperative
antibiotic prophylaxis and before PVI disinfection, were
part of the normal conjunctival flora and similar to previously published studies of patients undergoing ocular surgery (13, 14). It is thought that the major source of postoperative infections is the bacteria from the conjunctival
and eyelid flora of patients undergoing intraocular surgery.
Therefore, the preoperative reduction of the conjunctival
bacterial load may reduce the risk of postoperative endophthalmitis. Povidone-iodine has been shown to be an effective and well-tolerated antiseptic in ophthalmic surgery
(7, 15). Apt et al demonstrated a reduction in numbers of
colonies by 91% and a decrease in the number of species
of 50% following the application of one drop 5% PVI in the
cul-de-sac (15). In a prospective study, Mio de Kaspar et
al showed that irrigation of the fornices with 5% povidoneiodine was associated with significantly fewer positive
conjunctival cultures at the time of surgery compared with
the application of 2 drops on the conjunctiva. This suggests that irrigation of the conjunctival sac may be superior in reducing the conjunctival bacterial load (11). While
prospective studies have shown that topical antibiotics
in combination with PVI significantly reduce conjunctival
bacterial load, no study has been able to demonstrate that
the additional application of topical antibiotics reduces the
risk of postoperative endophthalmitis (16).

Despite all efforts to minimize the preoperative conjunctival


bacterial load, surgical instruments and aspirates of aqueous humor continue to show bacterial contamination. Ten
out of 39 (26%) microsurgical knives used for paracentesis
in cataract surgery were contaminated, while needles used
in strabismus surgery were contaminated in 15.1% and
19% according to 2 other studies (17-19).
A previously published study on 39 patients showed no difference between preoperative periorbital disinfection with 10%
PVI for 5 minutes and 5% PVI for 1 minute (10). In contrast,
our study suggest that the topical application of 3 additional
drops of 10% PVI directly into the conjunctival sac results in
a statistically significant greater reduction in the conjunctival
contamination rate than irrigation with 1% PVI alone.
The baseline cultures (T1) were similar between the control
group and the study group for the outpatient group but different for the inpatient group. The reason for this difference is
unclear as patients were randomized to the control and study
groups. We found no difference in the dosing of preoperative
antibiotics between the control and study groups (data not
shown). Despite an initially higher positive culture rate for the
study group at T1, the additional drops of 10% PVI resulted in
a greater reduction of conjunctival bacterial flora at T2 and T3,
as demonstrated by a significantly lower positive culture rate
for the study group compared to the control group.
There are several limitations to our study. First of all, this
study provides only qualitative data (percentage of positive cultures), and therefore, no conclusions on the number
of colony-forming units can be drawn. Second, conjunctival
cultures were not obtained prior to the administration of antibiotics. However, since patients were randomized, we would
not expect a difference in the patient population between
the control and study group. Finally, as with many published
studies, ours focused on the conjunctival bacterial flora as a
surrogate marker for the risk for endophthalmitis. No studies
have proven a correlation between conjunctival contamination and endophthalmitis and therefore, we cannot conclude
from our results regarding the actual risk of endophthalmitis.
Despite the limitations of our study, our results suggest
that additional drops of 10% PVI to the conjunctival sac
reduced the conjunctival contamination rate in patients undergoing cataract surgery. This reduction is in addition to
the known efficacy of 10% PVI periorbital scrub and 1%
PVI irrigation of the conjunctiva. Further studies could be
considered to quantify the effects of 10% PVI drops on the
conjunctival bacterial flora relative to the risk of postoperative endophthalmitis.

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10% Povidone iodine as prophylaxis before cataract surgery

ACKNOWLEDGEMENTS
Supported in part by Georg and Hannelore Zimmermann
Foundation, Germany.
The authors report no proprietary interest.
The data were presented in part at the 107th meeting of the German
Ophthalmological Society (DOG), Leipzig, Germany, September 2427, 2009.

Address for correspondence:


Dr. Martin M. Nentwich
Ludwig-Maximilians-University
Department of Ophthalmology
Klinikum der Universitt Mnchen
Campus Innenstadt
Mathildenstrasse 8
80336 Munich
Germany
Martin.Nentwich@med.uni-muenchen.de

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