Collagenase treatment for ocular burns
Recruiting
- Conditions
- Other specified disorders of cornea,
- Registration Number
- CTRI/2021/08/035994
- Lead Sponsor
- Hyderabad Eye Research Foundation
- Brief Summary
We propose to investigate the drug Collagenase in a prospective open-label randomized controlled academic clinical trial. In particular, we aim at evaluating the safety and efficacy of topical collagenase for the treatment of adult patients with acute severe unilateral chemical burns. This trial will be single centre, performed at the LV Prasad Eye Institute (LVPEI), in Hyderabad, India.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 30
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 (<14 days after injury) severe (grade II-IV) unilateral chemical burn.
- 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
Unwillingness to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of cases showing complete restoration (epithelialization) of the ocular surface on clinical slit-lamp evaluation using fluorescein staining. 28 days
- Secondary Outcome Measures
Name Time Method The proportion of patients showing 2-line improvement in BCVA from baseline will be computed along with 95% CIs. The secondary end points will be at 3-months, 6-months and 1-year follow up visit.
Trial Locations
- Locations (1)
LV Prasad Eye Institute
🇮🇳Hyderabad, TELANGANA, India
LV Prasad Eye Institute🇮🇳Hyderabad, TELANGANA, IndiaDr Sayan BasuPrincipal investigator04068102511sayanbasu@lvpei.org