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A prospective clinical trial for the treatment of keratoconjunctivitis caused by microsporidia.

A prospective, double-masked, randomized, clinical trial to evaluate the efficacy of debridement in the treatment of keratoconjunctivitis caused by microsporidia.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/11/002132
Enrollment
72
Registered
2011-11-16
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- Patients presenting with clinically diagnosed superficial epithelial microsporidial keratitis or keratoconjunctivitis.

Interventions

Intervention1: Debridement: Debridement of all the lesions will be done using a sterile no. 15 blade on a Bard-Parker handle for patients in the debridement group (arm). Corneal scrapings will be sub

Sponsors

Hyderabad Eye Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients presenting with clinically diagnosed superficial epithelial microsporidial keratitis or keratoconjunctivitis. Minimum of 10 discrete epithelial or subepithelial lesions on presentation. Must be able to read and sign an informed consent form or if the patient is under 18 years of age, the informed consent must be understood and signed by the patient?s parent or guardian. Must agree to ensure compliance with the visit schedules and/or other requirements of the study, or the parents or guardians of patients less than 18 years of age must agree to ensure the above compliance.

Exclusion criteria

Exclusion criteria: Any clinically diagnosed case of superficial microsporidial keratoconjunctivitis with less than 10 discrete lesions. Presence of stromal infiltrates at presentation.

Design outcomes

Primary

MeasureTime frame
Time taken from the presentation to complete resolution of the clinical signs and symptoms (resolution is defined as absence of corneal lesion).Timepoint: All patients will be examined on day 0, 3, 7 and at weekly intervals until resolution of clinical signs and symptoms.

Secondary

MeasureTime frame
Final visual acuity following resolution of symptoms. Residual corneal scarring. Side-effects, if any.Timepoint: All patients will be examined on day 0, 3, 7 and at weekly intervals until resolution of clinical signs and symptoms.

Countries

India

Contacts

Public ContactSavitri Sharma

L. V. Prasad Eye Institute

sujatadas@lvpei.org0674-3987999

Outcome results

None listed

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