Clinical Trial: Cross-linking for Corneal Ulcers Treatment Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Cross-linking for Corneal Ulcers Treatment Trial

Brief 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.


Detailed Summary:

The proposed study is a randomized controlled trial to determine whether collagen cross-linking improves outcomes in microbial keratitis. Patients presenting to the Aravind Eye Hospitals in Madurai, India for treatment of microbial keratitis will be recruited for the proposed study. Approximately 266 patients will be enrolled in the study. Subjects presenting with bacterial keratitis will be randomized to receive medical therapy plus corneal collagen cross-linking at presentation or to receive medical therapy alone. All subjects with bacterial ulcers will receive standard topical antibiotic medications as required after the procedure.

Subjects with fungal keratitis will be randomized into one of four groups:

  1. collagen cross-linking + amphotericin;
  2. collagen cross-linking + natamycin;
  3. amphotericin alone;
  4. natamycin alone.

All study subjects will be followed for 12 months to evaluate response to treatment.

Investigators from the University of California, San Francisco (UCSF) will assist Aravind Eye Hospital with the study design, implementation, and analysis of the research, and will help fund the study. The investigators plan to visit Aravind to help with the study implementation. UCSF will play an important role in this study by assisting with the study design, implementation, analysis, and funding.


Sponsor: University of California, San Francisco

Current Primary Outcome: Microbiological cure on repeat culture [ Time Frame: 4 to 24 hours after enrollment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Best spectacle-corrected visual acuity [ Time Frame: 12 months ]
  • Scar size [ Time Frame: 12 months ]
    Measured by clinical exam
  • Adverse events including rate of perforation/need for therapeutic penetrating keratoplasty [ Time Frame: 12 months ]
  • Corneal thinning [ Time Frame: 12 months ]
    As measured on Pentacam
  • Topography [ Time Frame: 12 months ]
    As measured on Pentacam
  • Corneal Higher Order Aberrations [ Time Frame: 12 months ]
    As measured on Pentacam
  • Vision related quality of life [ Time Frame: 3 months ]
    As measured by the Indian Visual Function Questionnaire


Original Secondary Outcome:

  • Best spectacle-corrected visual acuity [ Time Frame: 12 months ]
  • Scar size [ Time Frame: 12 months ]
    Measured by clinical exam
  • Adverse events including rate of perforation/need for therapeutic penetrating keratoplasty [ Time Frame: 12 months ]
  • Corneal thinning [ Time Frame: 12 months ]
    As measured on Pentacam
  • Topography [ Time Frame: 12 months ]
    As measured on Pentacam
  • Corneal Higher Order Aberrations [ Time Frame: 12 months ]
    As measured on Pentacam
  • Vision related quality of life [ Time Frame: 3 months ]
    Change in the Indian Vision Function Questionnaire from baseline to 3 months.


Information By: University of California, San Francisco

Dates:
Date Received: September 15, 2015
Date Started: November 2015
Date Completion: November 2020
Last Updated: April 25, 2017
Last Verified: April 2017