Clinical Trial: Effectiveness of Corneal Accelerated Crosslinking for Infectious Keratitis

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

Official Title: Effectiveness of Corneal Accelerated Crosslinking Versus Conventional Treatment for Infectious Keratitis

Brief Summary: The objective of this study is to evaluate the efficacy and safety of accelerated cross-linking (Avedro Inc., Waltham, USA) in the management of microbial keratitis as adjunctive therapy.

Detailed Summary:

Investigators perform a comprehensive ophthalmological examination, including evaluation of risk factors (immunosuppressive status, ocular trauma, previous ocular surgery, contact lens wear, topical corticosteroids use), best-corrected visual acuity (Snellen chart), slit-lamp biomicroscopy, tonometry and fundoscopy. In addition, anterior segment optical coherence tomography imaging (Visante, Carl Zeiss Meditec, Dublin, California, USA), corneal scrapes, culture and clinical photographs at day 1, day 7, month 1 and 3 will be analyzed.

Each participant will be assigned to one of four groups after randomization. Group 1: Initial ulcer on treatment with antibiotic plus sham (n = 66), these partcipants will receive only topical moxifloxacin 0,5% (Vigamoxi, Alcon, Texas, USA) and sham CXL; Group 2: Initial ulcer on treatment with antibiotic plus cross-linking (CXL) (n = 66) receive moxifloxacin plus CXL (riboflavin 0.1% during 10 minutes and irradiation 30 mW/cm2 during 3 minutes using accelerated CXL); Group 3: Refractory corneal ulcer on treatment with antibiotic plus sham (n=66), receive only topical antibiotic plus sham CXL; Group 4: Refractory corneal ulcer on treatment with antibiotic plus CXL will receive their standard medications plus CXL.

Statistical analysis will be divided into four phases: 1) Analysis of compliance, 2) Intention to treat, 3) Losses to follow-up and 4) Variable-response (healing) using Stata/MP 12.0 (Stata Corp., College Station, TX).


Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Current Primary Outcome: Healing [ Time Frame: Three months ]

Full epithelialization without evidence of infiltrates


Original Primary Outcome: Same as current

Current Secondary Outcome: Complications [ Time Frame: Three months ]

Complications associated with accelerated corneal cross-linking, such as corneal perforation or progression


Original Secondary Outcome: Same as current

Information By: Instituto de Oftalmología Fundación Conde de Valenciana

Dates:
Date Received: August 1, 2016
Date Started: June 2015
Date Completion: March 2017
Last Updated: August 9, 2016
Last Verified: August 2016