The Role of Adjuvant Corneal Crosslinking in the Management of Infective Keratitis

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 21, 2018

Primary Completion Date

November 11, 2021

Study Completion Date

February 3, 2022

Conditions
Infective Keratitis
Interventions
PROCEDURE

Corneal Collagen Cross-Linking Solutions

Topical anaesthesia was achieved using 0.4% benoxinate hydrochloride drops. Epithelium was removed up to 9 mm diameter. Corneal thickness of the area to be treated was measured (without epithelium) aiming for a starting thickness of no less than 350μm. Corneas thicker than 500μm were dehydrated to reduce thickness by using 70% Glycerol drops applied topically at intervals of 2-3 seconds for a total of five minutes. A schematic representation of PACK-CXL protocol is provided in Figure 1. Iso-osmolar riboflavin drops were instilled topically on the cornea at regular intervals of 2 minutes for a total period of 30 minutes. Thickness was also re-measured every 5 min to ensure that it remained below 500µm during instillation of riboflavin. The cornea was illuminated using a UVX, UV-A 365 nm with an irradiance of 3 mW/cm2 for 30 minutes and a total dose of 5.4 J/cm2 during which riboflavin was instilled every 2 min and corneal pachymetry performed every 5 min. PACK-CXL was performed in a 9

DRUG

Topical Antimicrobial/Antifungal Medications

Initial antimicrobial therapy for both groups consisted of fortified vancomycin eye drops 50 mg/ml, fortified ceftazidime eye drops 50 mg/ml hourly, and the antifungal agent itraconazole 100 mg orally twice per day. This regimen was subject to change according to microbiology culture sensitivities and/or results.

Trial Locations (2)

Unknown

Research Institute of Ophthalmology, Giza

Research Institute of Ophthalmology, Giza

All Listed Sponsors
lead

Research Institute of Ophthalmology, Egypt

OTHER

NCT06967376 - The Role of Adjuvant Corneal Crosslinking in the Management of Infective Keratitis | Biotech Hunter | Biotech Hunter