Effectiveness of Corneal Accelerated Crosslinking for Infectious Keratitis
Study Details
Study Description
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 |
|---|---|---|
|
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Healing [Three months]
Full epithelialization without evidence of infiltrates
Secondary Outcome Measures
- Complications [Three months]
Complications associated with accelerated corneal cross-linking, such as corneal perforation or progression
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto de Oftalmologia Conde de Valenciana | Mexico City | Mexico | 06800 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CEI-2015/01/02