Povidone-iodine for Ophthalmia Neonatorum Prophylaxis (2023)


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  • Cited by (51)
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American Journal of Ophthalmology

Volume 118, Issue 6,

December 1994

, Pages 701-706

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The agents currently used to prevent ophthalmia neonatorum are less than optimal, with reports indicating evidence of bacterial resistance, ineffectiveness, and toxicity. Povidone-iodine ophthalmic solution, which has been shown to be effective in the preoperative preparation of the eye, generates no resistance, is an effective antimicrobial agent, and has low toxicity. We evaluated the effectiveness and safety of povidone-iodine for ophthalmia neonatorum prophylaxis.

(Video) most asked questions regarding povidone iodine


A bacterial culture was taken from the conjunctiva of each eye of 100 infants within 30 minutes of birth. A drop of 2.5% povidone-iodine solution was then placed on one eye, while the other eye received either one drop of silver nitrate 1% ophthalmic solution or 0.5% erythromycin ointment. Conjunctival bacterial cultures were again taken two to four hours after birth. At each culture and at 24 hours after birth, the eyes were examined for toxic changes. To measure the effectiveness of the medications, the number of bacterial colony-forming units and species from each culture was compared.


All three agents significantly reduced the number of colony-forming units, but povidone-iodine caused the most significant decrease. The number of species was reduced significantly by povidone-iodine (P = .00051) and silver nitrate (P = .007), with povidoneiodine yielding the most significant decrease. Erythromycin did not significantly reduce the number of species. Silver nitrate demonstrated more ocular toxicity at the 24-hour determination point than did either of the other two medications (P < .001).


Povidone-iodine 2.5% ophthalmic solution is an effective antibacterial agent on the conjunctiva of newborns and causes less toxicity than silver nitrate.

References (22)

  • TaylorJ

    Appropriate eye drugs for developing countries

    Int Ophthalmol


  • Cited by (51)

    • Prospective, Randomized Clinical Trial of Povidone-Iodine 1.25% Solution Versus Topical Antibiotics for Treatment of Bacterial Keratitis

      2017, American Journal of Ophthalmology

      Citation Excerpt :

      It is also shown to be an effective anti-infective when applied to the eye following surgery.14 Povidone-iodine reduces bacterial counts when applied to the conjunctivae of neonates.15 In a study of 3117 newborns in Kenya, it was shown that povidone-iodine 5% solution was as or more effective than silver nitrate solution or erythromycin ointment for prophylaxis against ophthalmia neonatorum, while also being safe.

      To compare povidone-iodine 1.25% ophthalmic solution with topical antibiotics for treatment of bacterial keratitis in areas of the world where use of effective topical antibiotics may not be an option.

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      Randomized, controlled, investigator-masked clinical trial.

      We randomized 172 individuals with bacterial keratitis to topical treatment with povidone-iodine or antibiotics (neomycin–polymyxin B–gramicidin in the Philippines; ciprofloxacin 0.3% in India). Using survival analysis, we compared intervals from start of treatment to “presumed cure” (primary outcome measure, defined as a closed epithelial defect without associated inflammatory signs) and to “recovering” (residual epithelial defect <1mm2 with only minimal inflammation).

      Median interval to presumed cure in the Philippines was 7days for povidone-iodine and 7days for neomycin–polymyxin B–gramicidin (95% confidence interval [CI] for difference in median interval,−9.5 to 0.7days) and in India was 12days for povidone-iodine and 17days for ciprofloxacin (95% CI,−35.2 to 3.2days). Hazard ratio (HR) for presumed cure among those treated with povidone-iodine (vs antibiotics) was 1.46 in the Philippines (95% CI, 0.90–2.36; P= .13) and 1.70 in India (95% CI, 0.73–3.94; P= .22). Comparisons of intervals to recovering and HR for recovering also revealed no significant differences between treatment groups in either country.

      There is no significant difference between the effect of topical povidone-iodine 1.25% and topical antibiotics commonly available in the developing world for treatment of bacterial keratitis. Povidone-iodine 1.25%, which is widely available and inexpensive, can be considered for treatment of bacterial keratitis when antibiotic treatment is not practical.

    • Conjunctivitis, Keratitis and Infections of Periorbital Structures

      2017, Infectious Diseases, 2-Volume Set

    • Efficacy comparison between povidone iodine 2.5% and tetracycline 1% in prevention of ophthalmia neonatorum

      2011, Ophthalmology

      Citation Excerpt :

      The occurrence of noninfectious conjunctivitis in the povidone-treated group may have been a result of the toxic effect of the povidone. This mechanism was also suggested by Isenberg et al.7,8 The infectious agents causing ON were similar between the 2 groups, and this probably reflects the nonselective, broad-spectrum activity of both povidone iodine and tetracycline.

      To evaluate the efficacy of povidone iodine solution 2.5% and tetracycline ointment 1% in prevention of ophthalmia neonatorum (ON).

      Prospective, randomized, controlled observational study.

      Three-hundred ninety-four full-term neonates.

      A randomized comparison between 201 neonates randomly treated with povidone iodine 2.5% solution and 193 treated with tetracycline 1% ointment.

      Incidence of ON.

      The incidence of ON was significantly higher after povidone iodine than tetracycline prophylaxis (15.4% and 5.2% respectively; P = 0.001). Noninfective ON developed in 10 (5%) of the 201 neonates treated with povidone iodine and in none (0%) of the neonates treated with tetracycline (P = .002). Infective ON was detected in 21 (10.4%) of the neonates treated with povidone iodine and in 10 (5.2%) after treatment with tetracycline (P = .052). Ophthalmia neonatorum appeared more commonly in the first 3 days after treatment with povidone iodine (P = .043). The spectrum of the infective isolates was similar in the 2 groups.

      Povidone iodine was associated with noninfective (sterile) conjunctivitis, probably because of its toxicity to the ocular surface in neonates. Tetracycline was marginally more effective against infective ON. For these reasons, tetracycline, rather than povidone iodine, is recommended for prevention of ON.

      The author(s) have no proprietary or commercial interest in any materials discussed in this article.

    • A Meta-analysis of the Efficacy of Ocular Prophylactic Agents Used for the Prevention of Gonococcal and Chlamydial Ophthalmia Neonatorum

      2010, Journal of Midwifery and Women's Health

      Citation Excerpt :

      Of the 26 publications retrieved, eight studies were eligible for inclusion in this review. Many of the ineligible publications were excluded because they did not report GON or CON as an outcome.8,21,22,27,31,33,36,38,39 Two publications were review articles32,34 one was a commentary,29 one study did not investigate an eligible intervention,19 translation was not available for two publications (so eligibility could not be fully determined),28,35 one study was an observational design,40 and the remaining two studies were secondary analyses of included studies.20,23

      Neonatal eye prophylaxis has been routine in North America for more than a century. Contextual changes justify reexamining this practice, and prompted a systematic review of the efficacy of prophylactic agents.

      We searched MEDLINE (1966–2008), EMBASE (1980–2008), CINAHL (1982–2008), and the Cochrane library (the first quarter of 2008) for relevant clinical trials and hand-searched the resulting reference lists. We independently evaluated eligibility and study quality. Meta-analyses were performed using a random effects model.

      Each of the eight included studies had substantial methodologic weaknesses. Data to estimate the efficacy of prophylaxis in the prevention of gonococcal ophthalmia neonatorum (GON) were not available. One study found no differences in rates of chlamydial ophthalmia neonatorum (CON) when three agents were compared to no prophylaxis: silver nitrate (relative risk [RR] = 1.06; 95% confidence interval [CI], 0.55–2.02; 2225 newborns), erythromycin (RR = 0.93; 95% CI, 0.48–1.79; 2306 newborns), and tetracycline (RR = 0.82; 95% CI, 0.42–1.63; 2299 newborns). No statistically significant differences were found between agents in the prevention of GON. Erythromycin and povidone-iodine both decrease the risk of CON when compared to silver nitrate (RR = 0.71; 95% CI, 0.52–0.97; 4514 newborns, and RR = 0.52; 95% CI, 0.38–0.71; 2005 newborns, respectively).

      Failure rates of universal eye prophylaxis support reexamination of this policy where the prevalence of maternal infection is low.

    • Conjunctivitis, keratitis and infections of periorbital structures

      2010, Infectious Diseases: Third Edition

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    • Systematic review of the literature on the efficacy of ocular prophylaxis, in a delivery room, in healthy full-term newborn, in France

      2009, Revue Sage - Femme

      Évaluer le niveau de preuve de la prophylaxie oculaire, en salle de naissance, chez les nouveau-nés sains, à terme, en France.

      Revue systématique de la littérature à partir de mots-clés Mesh, dans la banque de données Medline. Sélection d’articles en français et anglais (méta-analyses, études randomisées contrôlées, essais cliniques, recommandations pour la pratique clinique, revues), du 1er janvier 1987 au 15 juin 2007, incluant des nouveau-nés sains, à terme, recevant une dose prophylactique dans chaque œil, en salle de naissance. Une première sélection a été réalisée après lecture des titres et/ou abstracts, et une seconde grâce à l’évaluation de la qualité des essais par deux experts (niveaux de preuve et de pertinence).

      Cette revue systématique inclut cinq études: trois essais contrôlés randomisés (un de niveau de preuve I, deux de niveau de preuve II), un essai clinique non randomisé et une étude cas témoins (niveau de preuve III). Trois comparent différents agents prophylactiques entre eux et deux semblent en faveur de la povidone-iodée. Seuls deux articles ont un groupe témoin ne recevant pas de prophylaxie. Les résultats semblent difficiles à interpréter (variabilité des populations, des méthodes) et à appliquer à la population française dont les niveaux socioéconomiques et sanitaires sont plutôt favorables (faible taux de gonococcie maternelle, bons soins prénataux).

      Étant donné l’insuffisance de preuve, il semble difficile de donner une conduite à tenir généralisée à appliquer en salle de naissance, en France, chez les nouveau-nés sains, à terme. Une prise en charge individualisée en évaluant les facteurs de risque de l’enfant et en renforçant la prévention (diminution des facteurs de risque, examen clinique oculaire quotidien…) serait peut-être plus appropriée.

      To assess the level of proof of ocular prophylaxis, in a delivery room, in healthy full-term newborn, in France.

      Systematic review of the literature from Mesh key-words, in the Medline data bank. Selection of articles in French and English (meta-analyses, controlled randomised studies, clinical trials, recommendations for clinical practice, journals), from 1st January 1987 to 15th June 2007, including healthy full-term newborn, receiving a prophylactic dose in each eye, in the delivery room. A first selection was carried out after reading the titles and/or abstracts, and a second based on the evaluation of trials by two experts (level of proof and pertinence).

      This systematic review includes five trials: randomised controlled trials (one with level of proof I, 2 with level of proof II), one non randomised clinical trial and one case-control trial (level of proof III). Three compare different prophylactic agents and two seem to favour of povidone-iodine. Only two articles had a control group that did not receive a prophylaxis. The results are difficult to interpret (variability of populations and methods) and apply to the French population as the socioeconomic and sanitary levels are rather favourable (low rate of maternal gonorrhoea, good prenatal care).

      Given the lack of proof, it seems difficult to provide a generalised recommendation for application in the delivery room for full-term newborn in France. Individualised care by assessing the factors of risk for the child and by reinforcing prevention (reduction in the factors of risk, daily eye examination, etc.) seems to be more appropriate.

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