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Outcome of Acanthamoeba keratitis with adjuvant oral Miltefosine.

To assess the outcome of Acanthamoeba keratitis on combination of topical Biguanides and oral Miltefosine.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029120
Enrollment
109
Registered
2020-11-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: B601- Acanthamebiasis

Interventions

Intervention1: Addition of oral Miltefosine: Once the diagnosis of Acanthamoeba keratitis is confirmed microbiologically, all the patients will be advised the combination of biguanides (PHMB 0.02% wit

Sponsors

L V Prasad Eye Instituta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with age more than 18 years 2.Microbiologically proven Acanthamoeba keratitis 3.Patients willing to participate and follow up.

Exclusion criteria

Exclusion criteria: 1.Patients with age less than 18 years 2.Pregnant and lactating females 3.Patients who are likely to be pregnant are relative contraindicated. 4.Patient not willing to participate and follow up 5.Patients with known allergy to Miltefosine 6.Patients with epithelial or sub epithelial keratitis with only anterior stroma involvement with less than 4 mm.

Design outcomes

Primary

MeasureTime frame
BCVA, Healing time, Number of corneal ulcers responded on medical treatmentTimepoint: 0 week, 1 week, 2 week , 1 month, 3 month, 6 months

Secondary

MeasureTime frame
Number of patients needed glue or undergone therapeutic Penetrating keratoplasty (TPK) for worsening of infection.Timepoint: It will be observed as a pilot trial of 10 patients for 6 months and later continued for 2 years. we will perform analysis of these cases after 6 months 1 week, 1 month, 2 months and 4 months.

Countries

India

Contacts

Public ContactDrBhupesh Bagga

L V Prasad Eye Institute

bhupesh@lvpei.org9618276424

Outcome results

None listed

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