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Comparitive study for management of Acanthameba keratitis

A randomized masked clinical trial to assess the efficacy of 1% Voriconazole ophthalmic solution compared to combined use of topical 0.02% Polyhexamethylene biguanide and 0.02% Chlorhexidine ophthalmic solutions in the treatment of Acanthameba keratitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013133
Enrollment
30
Registered
2018-04-10
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: null- Acanthameba keratitis

Interventions

Intervention1: voriconazole: Ophthalmic Eye drops Control Intervention1: Polyhexamethylene biguanide and Chlorhexidine: Ophthalmic Eye drops

Sponsors

L V Prasad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age equal to or more than 18 years. 2) Male or female 3) Stromal infiltrate size between 2-6 mm. 4) Corneal scraping positive for Acanthamoeba cysts in direct smear examination by any one or more of the methods used.

Exclusion criteria

Exclusion criteria: 1) The corneal scrapings are negative for Acanthamoeba. 2) The patient has a history of allergy to voriconazole or chlorhexidine 3) The cornea or sclera has been perforated or perforation is impending. 4) The unaffected eye is legally blind. . 5) The patient is known to be HIV positive or diabetic. 6) The initial culture shows significant growth of bacteria ( >10 colonies) or fungus. 7) Both eyes are infected.

Design outcomes

Primary

MeasureTime frame
Treatment failure â?? failure to induce a favorable clinical response within two weeks of initiating therapy with either voriconazole or combined therapy.Timepoint: 2 weeks

Secondary

MeasureTime frame
Time to healing, visual acuity change, scarTimepoint: 2 weeks

Countries

India

Contacts

Public ContactDr Bhupesh Bagga

LV Prasad Eye Institute

bhupesh@lvpei.org

Outcome results

None listed

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