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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95560917

Enrollment

200

Registered

2021-10-27

Start date

2023-01-02

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Microbial keratitis Eye Diseases

Interventions

Current as of 12/02/2026: A total of 40 primary health centres will be enrolled: 20 clusters in each arm

each cluster serves a population of around 5000 people. The primary health centres will be the units of randomisation. Previous: 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 primary health centres will be randomised to one

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

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 (BSCVA vision less than 3/60) measured by a trial-certified optometrist	—

Secondary

Measure	Time frame
Current key secondary outcome(s) as of 23/01/2026: 1. BSCVA at 3 months by a trial certified optometrist 2. Scar/infiltrate size at 3 months, slit lamp examination by ophthalmologists (trial certified). 3. Perforation and/or Conjunctival flaps and/or therapeutic corneal transplant (TPK) by three months, slit lamp examination by ophthalmologists. 4. Diagnostic accuracy in primary care 5. Time between symptom onset and presenting to primary care facility 6. Adherence to and time taken to attend referral at eye hospital 7. Quality of life questionnaires: EQ-5D, WHO/PBD-VF20, WHOQOL-BREF 8. Cost effectiveness analysis _____ Previous key secondary outcome(s): 1. Scar/infiltrate size at 3 months, slit-lamp examination by ophthalmologists (trial certified) 2. Perforation and/or therapeutic corneal transplant (TPK) by 3 months, 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 questionnaires: EQ-5D, WHO/PBD-VF20, WHOQOL-BREF measured at baseline and at 3 months. 7. Cost effectiveness analysis measured using EQ5-D and direct cost questionnaire at baseline and at 3 months	—

Measure

Time frame

Current key secondary outcome(s) as of 23/01/2026: 1. BSCVA at 3 months by a trial certified optometrist 2. Scar/infiltrate size at 3 months, slit lamp examination by ophthalmologists (trial certified). 3. Perforation and/or Conjunctival flaps and/or therapeutic corneal transplant (TPK) by three months, slit lamp examination by ophthalmologists. 4. Diagnostic accuracy in primary care 5. Time between symptom onset and presenting to primary care facility 6. Adherence to and time taken to attend referral at eye hospital 7. Quality of life questionnaires: EQ-5D, WHO/PBD-VF20, WHOQOL-BREF 8. Cost effectiveness analysis _____ Previous key secondary outcome(s): 1. Scar/infiltrate size at 3 months, slit-lamp examination by ophthalmologists (trial certified) 2. Perforation and/or therapeutic corneal transplant (TPK) by 3 months, 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 questionnaires: EQ-5D, WHO/PBD-VF20, WHOQOL-BREF measured at baseline and at 3 months. 7. Cost effectiveness analysis measured using EQ5-D and direct cost questionnaire at baseline and at 3 months

—

Countries

Nepal

Contacts

Public ContactSandip Das Sanyam

dassandiip@gmail.com+977 33-560402

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026