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Collagenase treatment for ocular burns

Safety and efficacy of collagenase application in ocular burns: A prospective open- label academic randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035994
Enrollment
30
Registered
2021-08-27
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: H188- Other specified disorders of cornea

Interventions

Intervention1: Collagenase: In the study group patients receive topical application of collagenase (0.2mg/ml) soaked surgical sponge for 15 mins followed by direct application of human amniotic membr

Sponsors

Hyderabad Eye Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient should be 18 years and above of age. 2. Patient should be able and prepared to complete all required clincial tests and examinations. 3. Patient should be diagnosed with an acute ( 4. Patient should not have any other ocular abnormality in the injured eye. 5. Able to provide informed consent prior to any study related procedures.

Exclusion criteria

Exclusion criteria: 1. Unwillingness to participate in the study. 2. Inability to come for all follow-up visits.

Design outcomes

Primary

MeasureTime frame
Proportion of cases showing complete restoration (epithelialization) of the ocular surface on clinical slit-lamp evaluation using fluorescein staining.Timepoint: 28 days

Secondary

MeasureTime frame
The proportion of patients showing 2-line improvement in BCVA from baseline will be computed along with 95% CIs.Timepoint: The secondary end points will be at 3-months, 6-months and 1-year follow up visit.

Countries

India

Contacts

Public ContactDr Sayan Basu

LV Prasad Eye Institute

viveksingh@lvpei.org04068102286

Outcome results

None listed

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