CompletedPhase 2

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

Indonesia32 participantsStarted 2024-07-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Corneal Re-epithelialization

Timeframe: Day 28 (week 4)

Trial details

NCT IDNCT07559149

SponsorGadjah Mada University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-13