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Clinical Trials/NCT02865876
NCT02865876
Unknown
Phase 3

Effectiveness of Corneal Accelerated Crosslinking Versus Conventional Treatment for Infectious Keratitis

Instituto de Oftalmología Fundación Conde de Valenciana1 site in 1 country264 target enrollmentJune 2015
ConditionsKeratitis

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Keratitis
Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
Enrollment
264
Locations
1
Primary Endpoint
Healing
Last Updated
9 years ago

Overview

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 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).

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
March 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Healing

Time Frame: Three months

Full epithelialization without evidence of infiltrates

Secondary Outcomes

  • Complications(Three months)

Study Sites (1)

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