Comparing a comprehensive package of primary care to the standard of care to reduce blindness caused by severe corneal infections in Uganda

Cluster randomised controlled trial of a complex intervention package to reduce blindness from severe microbial keratitis in Uganda

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77975669

Enrollment

200

Registered

2023-06-23

Start date

2023-08-01

Completion date

Unknown

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial keratitis (MK) Infections and Infestations

Interventions

A total of 20 primary health centres will be enrolled

10 clusters in each arm

each cluster serves a population of around 10,000 people (total ~100,000 per arm). The primary health centres will be the units of randomisation. The travel time from the health centre and the directi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Acute MK characterised by: 1.1. Corneal epithelial ulceration >1mm diameter 1.2. Corneal stromal infiltrate 1.3. Acute inflammation: e.g. conjunctival injection, anterior chamber inflammatory cells, hypopyon 2. Informed consent

Exclusion criteria

Exclusion criteria: 1. Unwilling to participate in trial or attend follow-up 2. Aged less than 18 years 3. Pregnancy: self-reported 4. Breast feeding: self-reported 5. No light perception in the affected eye 6. Fellow eye visual acuity <6/60 7. Known allergy to study medication (including preservatives) 8. Previous penetrating keratoplasty in the affected eye 9. Bilateral corneal ulcers 10. Nationals of another country

Design outcomes

Primary

Measure	Time frame
The proportion of people who are blind at 3 months in the affected eye (best spectacle-corrected visual acuity [BSCVA] vision less than 3/60) measured by a trial-certified optometrist	—

Secondary

Measure	Time frame
1. Scar/infiltrate size at 3 months, measured by slit-lamp examination by ophthalmologists (trial certified) 2. Perforation and/or therapeutic corneal transplant (TPK) by 3 months, measured by slit-lamp examination by ophthalmologists 3. Diagnostic accuracy in primary care measured compared to the final definitive diagnosis reached at the referral eye hospital using microbiology and in vivo confocal microscopy performed at the referral eye hospital at baseline 4. Time between symptom onset and presenting to primary care facility measured using patient questionnaire at baseline 5. Adherence to and time taken to attend referral at eye hospital measured using the difference between patients’ presentation date to primary care and the presentation to the referral eye hospital 6. Quality of life measured using EQ-5D, WHO/PBD-VF20, WHOQOL-BREF at baseline and at 3 months 7. Cost-effectiveness analysis using EQ5-D and direct cost questionnaire at baseline and at 3 months	—

Measure

Time frame

1. Scar/infiltrate size at 3 months, measured by slit-lamp examination by ophthalmologists (trial certified) 2. Perforation and/or therapeutic corneal transplant (TPK) by 3 months, measured by slit-lamp examination by ophthalmologists 3. Diagnostic accuracy in primary care measured compared to the final definitive diagnosis reached at the referral eye hospital using microbiology and in vivo confocal microscopy performed at the referral eye hospital at baseline 4. Time between symptom onset and presenting to primary care facility measured using patient questionnaire at baseline 5. Adherence to and time taken to attend referral at eye hospital measured using the difference between patients’ presentation date to primary care and the presentation to the referral eye hospital 6. Quality of life measured using EQ-5D, WHO/PBD-VF20, WHOQOL-BREF at baseline and at 3 months 7. Cost-effectiveness analysis using EQ5-D and direct cost questionnaire at baseline and at 3 months

—

Countries

Uganda

Contacts

Public ContactSimon Arunga

simon.arunga@lshtm.ac.uk+256 (0)706397738

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026