Adjunctive Chlorhexidine In The Treatment Of Filamentous Fungal Keratitis: A Multicentre Randomised Controlled Trial
Published 2026 - 44th Congress of the ESCRS
Reference: FP10.11 | Type: Free paper | DOI: 10.82333/as4z-bf09
Authors: Dr Jeremy John Hoffman* 1 , Dr Simon Arunga 2 , Dr Einoti Matayan 3 , Dr Abel Ebong 4 , Francis Orishaba 4 , Dr William Makupa 3 , Dr Muna Elisante 3 , Dr Reena Yadav 5 , Mr Sandip Das Sanyam 6 , Dr Tara Mtuy 1 , Dr David Macleod 7 , A/Prof. Astrid Leck 8 , A/Prof. Victor Hu 8 , Prof. Matthew Burton 8
1International Centre for Eye Health,London School of Hygiene & Tropical Medicine,London,United Kingdom;Kilimanjaro Christian Medical Centre,Moshi,Tanzania, United Republic of, 2International Centre for Eye Health,London School of Hygiene & Tropical Medicine,London,United Kingdom;Mbarara University of Science and Technology,Mbarara,Uganda, 3Kilimanjaro Christian Medical Centre,Moshi,Tanzania, United Republic of, 4Mbarara University of Science and Technology,Mbarara,Uganda, 5Sagarmatha Choudhary Eye Hospital,Lahan,Nepal, 6International Centre for Eye Health,London School of Hygiene & Tropical Medicine,London,United Kingdom;Sagarmatha Choudhary Eye Hospital,Lahan,Nepal, 7London School of Hygiene & Tropical Medicine,London,United Kingdom, 8International Centre for Eye Health,London School of Hygiene & Tropical Medicine,London,United Kingdom
Purpose
To evaluate whether adjunctive topical chlorhexidine 0.2% improves visual and clinical outcomes compared with standard natamycin 5% monotherapy in the treatment of filamentous fungal keratitis, a condition frequently associated with corneal perforation, need for therapeutic keratoplasty, and poor visual prognosis.
Setting
Prospective multicentre randomised controlled trial conducted at tertiary ophthalmic centres in Tanzania and Uganda managing high volumes of infectious keratitis.
Methods
Participants with smear- or in vivo confocal microscopy-confirmed filamentous fungal keratitis were randomised to receive:
- Topical natamycin 5%, or
- Combination therapy with topical natamycin 5% plus chlorhexidine 0.2%.
Treatment was administered according to a prespecified protocol with intensive initial dosing.
The primary outcome was best spectacle-corrected visual acuity (BSCVA, logMAR) at 90 days, analysed using linear regression adjusted for baseline visual acuity and excluding mixed infections.
Secondary outcomes included:
- Corneal perforation or need for therapeutic keratoplasty
- Time to epithelial healing (survival analysis)
- Safety and adverse events.
Analyses followed the intention-to-treat principle with robust variance estimation.
Results
A total of 246 participants were included in the primary analysis.
There was a statistically significant difference in adjusted 90-day BSCVA between the two study arms (mean difference −0.16 logMAR; 95% CI −0.31 to −0.01; p=0.036).
Definite corneal perforation occurred in 32/122 (26.0%) eyes in Arm A and 14/120 (11.7%) in Arm B (Fisher’s exact p=0.005; OR≈0.37).
Time to epithelial healing differed between groups (HR≈1.40, p≈0.030).
Baseline disease severity was the strongest predictor of outcome across multivariable models.
Adverse events were uncommon (5/244, 2.0%) and similar between study arms.
Analyses were conducted with treatment groups coded according to the prespecified plan; treatment identities remain concealed pending formal unmasking.
Conclusions
In this multicentre randomised controlled trial, statistically and clinically significant differences were observed between treatment groups in visual acuity, corneal perforation rates, and epithelial healing time.
Treatment allocation remains masked in accordance with the prespecified statistical analysis plan. Full treatment attribution and complete clinical interpretation of the findings will be presented at the ESCRS Congress following formal unmasking. This study is designed to provide definitive evidence regarding the role of adjunctive chlorhexidine in the management of filamentous fungal keratitis.