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. 2020 Sep 30;10(9):e038066. doi: 10.1136/bmjopen-2020-038066

Table 1.

Inclusion and exclusion criteria for enrolment in stage 1 (MK cases) and stage 2 (the randomised controlled trial)

Inclusion criteria (all must be met) Exclusion criteria (any of the following)
Stage 1
1. Acute MK characterised by: 1. Patients aged less than 18 years
  • Corneal epithelial ulceration >1 mm diameter

2. Patients unable or unwilling to provide informed consent
  • Corneal stromal infiltrate

3. Patients who do not have acute MK or where there is a more likely alternative diagnosis
  • Acute inflammation: for example, conjunctival injection, anterior chamber inflammatory cells, hypopyon

2. Adults (18 years and older)
3. Able to provide informed consent
Stage 2
1. Acute MK characterised by: 1. Unwilling/unable to participate in trial and/or attend follow-up
  • Corneal epithelial ulceration >1 mm diameter

2. Aged less than 18 years
  • Corneal stromal infiltrate

3. Pregnancy: self-reported, or by urine pregnancy test if uncertain.
  • Acute inflammation: for example, conjunctival injection, anterior chamber inflammatory cells, hypopyon

4. Breast feeding: self-reported
2. Filamentous fungal hyphae visualised on smear microscopy and/or IVCM 5. Prior topical antifungal treatment
3. Agree to be randomised to either treatment arm and are able to give informed consent 6. No light perception in the affected eye
4. Agree to be followed up at 2 days, 1 week, 2 weeks, 3 weeks, 2 months and 3 months 7. Fellow eye visual acuity <6/60
5. Adults (18 years and older) 8. Acanthamoebic infection visualised by smear microscopy or IVCM
9. Clinical evidence of herpetic keratitis
10. Known allergy to study medication (including preservatives)
11. Previous keratoplasty in the affected eye
12. Bilateral corneal ulcers
13. Very severe ulcers warranting immediate evisceration or conjunctival flap
14. Endophthalmitis

IVCM, in vivo confocal microscopy; MK, microbial keratitis.