Effectiveness of Corneal Accelerated Crosslinking for Infectious Keratitis

Effectiveness of Corneal Accelerated Crosslinking Versus Conventional Treatment for Infectious Keratitis

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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).

Study Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Aida Jimenez-Corona, PhD
  • Phone Number: 3123 +5255880000
  • Email: aidaajc@gmail.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with infectious keratitis (initial or refractory to treatment) including bacterial or mycotic keratitis with size larger than 3 mm

Exclusion Criteria:

  • herpetic keratitis
  • Acanthamoeba keratitis
  • pregnancy
  • endophthalmitis
  • systemic immunosuppression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Accelerated Corneal Cross-linking
Cross-linking in the management of microbial keratitis is an adjunctive therapy.This procedure is conducted under sterile conditions in the operating room. Tetracaine hydrochloride 0.5% (Ponti Ofteno, Sophia, Mexico) eye drops is apply for topical anesthesia. The corneal epithelium on the edge of the ulcer is cautiously removed using a microsponge. As photosensitizer, riboflavin 0.1% (Vibex, Avedro Inc, Waltham, USA) is used for 10 minutes. After impregnation, the participant´s cornea is irradiaded with UVA-light (370 nm) using 30 mW/cm2 for 3 minutes (which corresponds to a total dose of 5.4J/cm2) with accelerated cross-linking (Avedro Inc., Waltham, USA). After procedure, conventional treatment for keratitis remains unchanged.
All participants in this group receiving conventional therapy (moxifloxacin 0,5% for bacterial keratitis or natamycin for mycotic keratitis) plus accelerated cross-linking (Avedro Inc., Waltham, USA) under topical anesthesia using 0.1% riboflavin (Vibex, Avedro Inc, Waltham, USA) for 10 minutes and irradiation 30 mW/cm2 during 3 minutes.
SHAM_COMPARATOR: Sham Accelerated Corneal Cross-linking
Placebo surgery. This procedure is conducted under sterile conditions in the operating room. Tetracaine hydrochloride 0.5% (Ponti Ofteno, Sophia, Mexico) eye drops is apply for topical anesthesia. Investigators do not perform removal of the corneal epithelium in edge of the ulcer. The researchers conducted "the impregnation phase" applying drops of saline solution for 10 minutes. After impregnation fase, a device is placed in Avedro equipment off (Avedro Inc, Waltham, USA) this device emits white light for 3 minutes. After procedure, conventional treatment for keratitis remains unchanged.
All participants in this group receiving conventional therapy (moxifloxacin 0,5% for bacterial keratitis or natamycin for mycotic keratitis) plus accelerated cross-linking (Avedro Inc., Waltham, USA) under topical anesthesia using 0.1% riboflavin (Vibex, Avedro Inc, Waltham, USA) for 10 minutes and irradiation 30 mW/cm2 during 3 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing
Time Frame: Three months
Full epithelialization without evidence of infiltrates
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Three months
Complications associated with accelerated corneal cross-linking, such as corneal perforation or progression
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Enrique Graue-Hernandez, MSc, Instituto de oftalmología Fundación Conde de Valenciana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (ESTIMATE)

August 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Investigators describe demographic characteristics of the participants, such as age, gender, etiology, intervention group and the response variables, complications and corneal healing.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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