Effectiveness of Corneal Accelerated Crosslinking for Infectious Keratitis
Keratitis
About this trial
This is an interventional treatment trial for Keratitis focused on measuring Infectious keratitis, Cross-linking
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
Sites / Locations
- Instituto de Oftalmologia Conde de ValencianaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Accelerated Corneal Cross-linking
Sham 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.
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.