Fungal keratitis Eye Diseases Keratitis
Conditions
Interventions
Current interventions as of 08/09/2021:
Participants will be randomised to either combined topical chlorhexidine 0.2% and topical natamycin 5% or topical natamycin 5% alone. The treatment will be gi
Sponsors
London School of Hygiene & Tropical Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Acute microbial keratitis characterised by: 1.1 Corneal epithelial ulceration >1 mm diameter 1.2 Corneal stromal infiltrate 1.3 Acute inflammation: e.g. conjunctival injection, anterior chamber inflammatory cells, hypopyon 2. Filamentous fungal hyphae visualised on smear microscopy and/or in vivo confocal microscopy 3. Agree to be randomised to either treatment arm and able to give informed consent 4. Agree to be followed up at 2 days, 1 week, 2 weeks, 3 weeks, 2 months and 3 months 5. Adults (18 years and older)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 08/09/2021: 1. Unwilling to participate in trial or attend follow-up 2. Aged less than 18 years 3. Pregnancy: self-reported, or by urine hCG pregnancy test if uncertain. 4. Breast feeding: selfreported 5. No light perception in the affected eye 6. Fellow eye visual acuity <6/60 7. Acanthamoebic infection visualised by smear microscopy or IVCM 8. Clinical evidence of herpetic keratitis 9. Known allergy to study medication (including preservatives) 10. Previous penetrating keratoplasty in the affected eye 11. Bilateral corneal ulcers 12. Nationals of another country 13. Very severe ulcers warranting immediate evisceration or conjunctival flap 14. Fungal Endophthalmitis _____ Previous exclusion criteria: 1. Pregnancy: self-reported, or by urine hCG pregnancy test if uncertain 2. Breast feeding: self-reported 3. Prior topical anti-fungal treatment 4. No light perception in the affected eye 5. Fellow eye visual acuity <6/60 6. Acanthamoebic infection visualised by smear microscopy or IVCM 7. Clinical evidence of herpetic keratitis 8. Known allergy to study medication (including preservatives) 9. Previous penetrating keratoplasty in the affected eye 10. Bilateral corneal ulcers 11. Very severe ulcers warranting immediate evisceration or conjunctival flap 12. Fungal Endophthalmitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Spectacle Corrected Visual Acuity (BSCVA) measured at 3 months by a trial certified optometrist | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to full epithelial healing (slit lamp examination by ophthalmologist at 2 days, 1 week, 2 weeks, 3 weeks, 2 months and 3 months) 2. Pin-hole visual acuity in logMAR at 3 months, trial-certified optometrist 3. Hard Contact Lens-corrected Visual Acuity measured in logMAR at 3 months 4. Scar/infiltrate size at 1 week, 3 weeks and 3 months (slit lamp examination by ophthalmologist) 5. Ulcer depth at 1 week and 3 weeks (slit lamp examination by ophthalmologist) 6. Hypopyon height at 1 and 3 weeks, (slit lamp examination by ophthalmologists) 7. Perforation and/or TPK by three months (slit lamp examination by ophthalmologist) 8. Positive culture rate assessed as the number of cases that test positive for fungus with microbiological culture, as a proportion of all cases of fungal keratitis at 1 week 9. Ocular adverse effects at each follow up visit (Day 2, Day 7, Day 14, 3 weeks, 2 months, 3 months), slit lamp examination by ophthalmologists 10. Quality of life (QoL) assessed using: EQ-5D, WHO/PBD-VF20, WHOQOL-BREF (comparison between baseline and QoL measures at 3 months) 11. Cost-effectiveness analysis, using EQ-5D data form 3 months and direct cost data 12. Drug adherence at each follow up visit (Day 2, Day 7, Day 14, 3 weeks, 2 months, 3 months) whilst the patient is using study medications | — |
Countries
Tanzania, Uganda
Contacts
Public ContactJeremy Hoffman
Outcome results
None listed