Chlorhexidine gluconate 0.2% as a treatment for recalcitrant fungal keratitis in Uganda: a pilot study.

OBJECTIVE: Fungal keratitis is a major ophthalmic public health problem, particularly in low-income and middle-income countries. The options for treating fungal keratitis are limited. Our study aimed to describe the outcomes of using chlorhexidine 0.2% eye-drops as additional treatment in the management of patients with recalcitrant fungal keratitis. METHODS: This study was nested within a large cohort study of people presenting with microbial keratitis in Uganda. We enrolled patients with recalcitrant fungal keratitis not improving with topical natamycin 5% and commenced chlorhexidine 0.2%. Follow-up was scheduled for 3 months and 1 year. The main outcome measures were healing, visual acuity and scar size at final follow-up. RESULTS: Thirteen patients were followed in this substudy. The patients were aged 27-73 years (median 43 years). Filamentous fungi were identified by microscopy of corneal scrape samples in all cases. Isolated organisms included Aspergillus spp, Fusarium spp, Candida spp, Bipolaris spp and Acremoninum spp. At the final follow-up, nine patients (75%) had healed; three had vision of better than 6/18. Three patients lost their eyes due to infection. In the remaining nine cases, corneal scarring was variable ranging from 4.6 to 9.4 mm (median 6.6 mm, IQR 5.9-8.0 mm); of these five had dense scars, three had moderate scars and one had a mild scar. None of the patients demonstrated signs of chlorhexidine toxicity during the follow-up. CONCLUSION: Chlorhexidine 0.2% was found to be a useful sequential adjunctive topical antifungal in cases of fungal keratitis not responding to natamycin 5%, which warrants further evaluation.

Topical chlorhexidine 0.2% versus topical natamycin 5% for fungal keratitis in Nepal: rationale and design of a randomised controlled non-inferiority trial.

INTRODUCTION: Fungal infections of the cornea, fungal keratitis (FK), are challenging to treat. Current topical antifungals are not always effective and are often unavailable, particularly in low-income and middle-income countries where most cases occur. Topical natamycin 5% is usually first-line treatment, however, even when treated intensively, infections may progress to perforation of the eye in around a quarter of cases. Alternative antifungal medications are needed to treat this blinding disease.Chlorhexidine is an antiseptic agent with antibacterial and antifungal properties. Previous pilot studies suggest that topical chlorhexidine 0.2% compares favourably with topical natamycin. Full-scale randomised controlled trials (RCTs) of topical chlorhexidine 0.2% are warranted to answer this question definitively. METHODS AND ANALYSIS: We will test the hypothesis that topical chlorhexidine 0.2% is non-inferior to topical natamycin 5% in a two-arm, single-masked RCT. Participants are adults with FK presenting to a tertiary ophthalmic hospital in Nepal. Baseline assessment includes history, examination, photography, in vivo confocal microscopy and cornea scrapes for microbiology. Participants will be randomised to alternative topical antifungal treatments (topical chlorhexidine 0.2% and topical natamycin 5%; 1:1 ratio, 2-6 random block size). Patients are reviewed at day 2, day 7 (with reculture), day 14, day 21, month 2 and month 3. The primary outcome is the best spectacle corrected visual acuity (BSCVA) at 3 months. Primary analysis (intention to treat) will be by linear regression, with treatment arm and baseline BSCVA prespecified covariates. Secondary outcomes include epithelial healing time, scar/infiltrate size, ulcer depth, hypopyon size, perforation and/or therapeutic penetrating keratoplasty (corneal transplant), positive reculture rate (day 7) and quality of life (EuroQol-5 dimensions, WHO/PBD-VF20, WHOQOL-BREF). ETHICS AND DISSEMINATION: The Nepal Health Research Council, the Nepal Department of Drug Administration and the London School of Hygiene and Tropical Medicine ethics committee have approved the trial. The results will be presented at local and international meetings and submitted to peer-reviewed journals for publication. TRIAL REGISTRATION NUMBER: ISRCTN14332621; pre-results.

Assault-related severe ocular chemical injury at a London ophthalmic referral hospital: a 3-year retrospective observational study.

OBJECTIVES: To understand the incidence, causes, management and outcomes of intentional (assault) and unintentional severe ocular chemical injuries (SOCI) at an urban tertiary referral centre in the UK. DESIGN: Retrospective observational study. SETTING: A London tertiary referral ophthalmic centre, Moorfields Eye Hospital. PARTICIPANTS: All cases of SOCI presenting between 1 September 2011 and 31 August 2014 were identified. The definition of SOCI was grade 3 or 4 on the Hughes-Roper-Hall classification system. We identified 25 cases (6 in 2011-2012, 8 in 2012-2013, 11 in 2013-2014). Median age was 31.1 years. 23 cases (92%) were male. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the proportion of cases of SOCI caused by assault, per year. Secondary outcome measures included the number of cases of SOCI, injury characteristics and mechanism, initial and long-term management, visual outcome and the need for surgical intervention. RESULTS: Between 2011 and 2012, 3/6 cases were due to assault (50%); between 2012 and 2013, 7/8 were due to assault (87.5%); and between 2013 and 2014, 6/11 were due to assault (54.4%). Assault was responsible for 16/25 (64%) cases overall, while 8/25 (32%) cases were work related. The causative agent was known to be alkali in 16/25 (64%), while 10/25 (40%) did not complete the follow-up. The mean number of clock hours of limbal ischaemia was 5.24 (SD 2.97). 17/25 (68%) were Hughes-Roper-Hall grade 3. Surgical intervention occurred in 1/25. The final best-corrected visual acuity was 6/12 or worse in 11/25 (44%) and was counting fingers or worse in 4/25 (16%). CONCLUSIONS: Previous studies found that SOCI had a low incidence and that work-related injuries were the most common cause. Our study demonstrates an increasing incidence of SOCI, which may be accounted for by a rise in assault using corrosive substances. A high number of patients did not attend regularly for follow-up and visual outcomes from these injuries are poor.