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Improving Cornea Healing by changing the Tissue structure

Improving Corneal Healing via Modulation of Tissue Biomechanics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026869
Enrollment
30
Registered
2020-07-29
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: H178- Other corneal scars and opacities

Interventions

Intervention1: Not Applicable: Not Applicable Control Intervention1: Normal Saline: On procedure say patients will receive a topical collagenase treatment in the limbus region prior to the direct appl

Sponsors

The Ulverscroft 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 questionnaires. 3. Patient should be diagnosed with an acute severe (grade II-IV) unilateral chemical burn. 4. Patient should not have any other ocular abnormality in the injured eye. 5. Able and willing to provide informed consent prior to any study related procedures. 6. Willingness and ability to attend for all the study visits with in required visits windows.

Exclusion criteria

Exclusion criteria: 1. The exclusion criteria include having a significant co-morbidity in which compliance with the study procedures would not be expected. 2. Unwillingness to participate

Design outcomes

Primary

MeasureTime frame
The primary outcome measures to be tested are improved visual acuity and the reduction of corneal haze and pain, determined using slit lamp biomicroscopy and clinical evaluation, respectivelyTimepoint: At each time point that is Day 1, 7, 14, 28 and months 3,6 and 12.

Secondary

MeasureTime frame
Secondary qualitative outcomes on the lack of blood vessels, epithelial defect, delayed epithelial staining and opaque tissue growth on the centre of the cornea will be recorded as a diagram and photographs that will assist in confirming the condition of the cornea. Epithelial defect size will be examiner-assessed and documented digitally by anterior segment imaging at follow-up visitsTimepoint: (DPP 0), at 1, 7, 14, 28 days (epithelial closure) post-procedure (DPP) and 3, 6, and 12 months post-procedure (MPP)

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