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Effectiveness of Corneal Accelerated Crosslinking for Infectious Keratitis

Effectiveness of Corneal Accelerated Crosslinking Versus Conventional Treatment for Infectious Keratitis

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02865876
Enrollment
264
Registered
2016-08-15
Start date
2015-06-30
Completion date
2017-03-31
Last updated
2016-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratitis

Keywords

Infectious keratitis, Cross-linking

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).

Interventions

PROCEDUREAccelerated 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.

Sponsors

Asociación para Evitar la Ceguera en México
CollaboratorOTHER
Instituto de Oftalmología Fundación Conde de Valenciana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HealingThree monthsFull epithelialization without evidence of infiltrates

Secondary

MeasureTime frameDescription
ComplicationsThree monthsComplications associated with accelerated corneal cross-linking, such as corneal perforation or progression

Countries

Mexico

Contacts

Primary ContactLucero Pedro-Aguilar, MD
lu.pedroaguilar@gmail.com+5255880000
Backup ContactAida Jimenez-Corona, PhD
aidaajc@gmail.com+5255880000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026