Effectiveness of Riboflavin-Moxifloxacin Amniotic Membrane as an Adjuvant for PACK-CXL in Moderate to Severe Infectious Keratitis

Amniotic Membrane Preparation Containing Riboflavin and Moxifloxacin as Therapeutic Adjuvants for Photo-Activated Chromophore Keratitis- Corneal Cross-Linking (PACK-CXL): Materials Development, Preclinical, and Clinical Trials

This study aims to evaluate the effectiveness of a specialized amniotic membrane preparation as an adjuvant therapy for patients with moderate-to-severe infected corneal ulcers.

The specialized membrane contains a combination of Riboflavin and Moxifloxacin, which is applied during Photo-Activated Chromophore Keratitis-Corneal Cross-linking (PACK-CXL) therapy. The researchers compare this new approach with the standard PACK-CXL procedure to see if it improves corneal healing (re-epithelialization) and reduces inflammation markers. The study was conducted in a randomized controlled trial format at Dr. Sardjito General Hospital, Yogyakarta.

Inclusion Criteria:

• Patients diagnosed with moderate-to-severe infectious corneal ulcers (bacterial or fungal origin) by the Infection and Immunology subdivision at Dr. Sardjito General Hospital, Yogyakarta
• Patients scheduled to undergo Photo-Activated Chromophore Keratitis-Corneal Cross-linking (PACK-CXL) therapy
• Patients aged 18 years and older
• Patients willing to undergo PACK-CXL therapy
• Patients capable of providing informed consent and willing to participate in the entire study protocol

Exclusion Criteria:

• Patients who refuse follow-up examinations (tear film collection, corneal staining, or corneal scans) after the PACK-CXL procedure
• Patients with damaged or insufficient clinical specimens (e.g., tear samples) for laboratory analysis
• Patients unable to commit to the follow-up schedule