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Trial record 7 of 556 for:    "keratitis-ichthyosis-deafness syndrome" OR "Keratitis"

Effectiveness of Corneal Accelerated Crosslinking for Infectious Keratitis

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ClinicalTrials.gov Identifier: NCT02865876
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Collaborator:
Asociación para Evitar la Ceguera en México
Information provided by (Responsible Party):
Instituto de Oftalmología Fundación Conde de Valenciana

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.

Condition or disease Intervention/treatment Phase
Keratitis Procedure: Accelerated Corneal Cross-linking Phase 3

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  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effectiveness of Corneal Accelerated Crosslinking Versus Conventional Treatment for Infectious Keratitis
Study Start Date : June 2015
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
Procedure: Accelerated Corneal Cross-linking
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.
Procedure: Accelerated Corneal Cross-linking
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.



Primary Outcome Measures :
  1. Healing [ Time Frame: Three months ]
    Full epithelialization without evidence of infiltrates


Secondary Outcome Measures :
  1. Complications [ Time Frame: Three months ]
    Complications associated with accelerated corneal cross-linking, such as corneal perforation or progression



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865876


Contacts
Contact: Lucero Pedro-Aguilar, MD +5255880000 ext 3204 lu.pedroaguilar@gmail.com
Contact: Aida Jimenez-Corona, PhD +5255880000 ext 3123 aidaajc@gmail.com

Locations
Mexico
Instituto de Oftalmologia Conde de Valenciana Recruiting
Mexico City, Mexico, 06800
Contact: Lucero Pedro-aguilar, MD       lu.pedroaguilar@gmail.com   
Contact: Enrique Graue-Hernandez, MD, MSc       egraueh@gmail.com   
Sponsors and Collaborators
Instituto de Oftalmología Fundación Conde de Valenciana
Asociación para Evitar la Ceguera en México
Investigators
Study Chair: Enrique Graue-Hernandez, MSc Instituto de Oftalmologia Fundacion Conde de Valenciana

Publications of Results:
Responsible Party: Instituto de Oftalmología Fundación Conde de Valenciana
ClinicalTrials.gov Identifier: NCT02865876     History of Changes
Other Study ID Numbers: CEI-2015/01/02
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Investigators describe demographic characteristics of the participants, such as age, gender, etiology, intervention group and the response variables, complications and corneal healing.

Keywords provided by Instituto de Oftalmología Fundación Conde de Valenciana:
Infectious keratitis
Cross-linking

Additional relevant MeSH terms:
Communicable Diseases
Infection
Keratitis
Corneal Diseases
Eye Diseases