A clinical trial to study the role of amniotic membrane in patients with chemical or thermal injury to the eye

• Conditions: Acute Ocular burns

• Registration Number: CTRI/2009/091/001018
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

This study was a prospective, randomized, controlled clinical trial to compare the efficacy of amniotic membrane transplantation in addition to standard medical therapy in patients with acute chemical or thermal ocular injury in terms of rate of healing of corneal epithelial defect, visual acuity, extent of corneal vascularization, corneal clarity and formation of symblepharon. We found that amniotic membrane transplantation in eyes with moderate ocular burns promotes faster healing of epithelial defect in patients with moderate grade burns.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Moderate and severe acute ocular burns.

Exclusion Criteria

Mild ocular burns, Patients who refused consent and were not available for follow up.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of healing of corneal epithelial defect,	day 1, day 7, weekly until 1 month, biweekly until 3 months, and monthly thereafter.

Secondary Outcome Measures

Name	Time	Method
visual acuity, extent of corneal vascularization, corneal clarity and formation of symblepharon.	day 1, day 7, weekly until 1 month, biweekly until 3 months, and monthly thereafter.

Trial Locations

Locations (1)

Dr. Rajendra Prasad Centre for Ophthalmic Sciences; 🇮🇳 Delhi, DELHI, India

Dr. Rajendra Prasad Centre for Ophthalmic Sciences

🇮🇳Delhi, DELHI, India

Prof Radhika Tandon

Principal investigator

11-26588626

radhika_tan@yahoo.com