CXL, Infected Corneal Ulcers
Conditions
Brief 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.
Interventions
COMBINATION_PRODUCTRiboflavin-Moxifloxacin Amniotic Membrane
Patients receiving PACK-CXL therapy with the addition of a specialized amniotic membrane containing 0.1% riboflavin and 0.5% moxifloxacin
OTHERStandard PACK-CXL
Patients receive standard Photo-Activated Chromophore Keratitis-Corneal Cross-linking (PACK-CXL) therapy according to national clinical guidelines
Sponsors
Gadjah Mada University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Re-epithelialization | Day 28 (week 4) | The speed and percentage of the corneal surface healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pro-inflammatory Cytokine Levels | Day before intervention (baseline), Day 7, Day 14, Day 28 | Measurement of IL-6, CXCL2, IL-1β, and IL-8 levels (pg/mL) in the corneal environment or tears to assess the reduction in inflammation |
Countries
Indonesia
Outcome results
None listed