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Cross-linking for Corneal Ulcers Treatment Trial

NCT02570321 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2025-06-18

Study results available
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Summary

The primary purpose of this study is to determine if patients randomized to corneal collagen cross-linking plus medical therapy will have a lower prevalence of positive bacterial or fungal cultures immediately after the procedure than patients who received medical therapy alone.

The secondary purpose of this study is to determine if patients randomized to corneal collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who receive medical therapy alone.

Conditions

  • Corneal Ulcer
  • Infectious Keratitis
  • Bacterial Ulcer
  • Fungal Ulcer

Interventions

PROCEDURE

Corneal Cross-linking

For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.

DRUG

Anti Fungal Drug

Topical Amphotericin B vs Topical Natamycin

Sponsors & Collaborators

Principal Investigators

  • Jennifer R Rose-Nussbaumer, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-06-18
Completion
2019-03-19
FDA Drug
Yes

Countries

  • United States
  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02570321 on ClinicalTrials.gov