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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Patients receiving standard PACK-CXL therapy without the specialized amniotic membrane adjuvant |
|
| Riboflavin-Moxifloxacin Amniotic Membrane (Intervention Group) | Experimental | Patients receiving PACK-CXL therapy with the addition of a specialized amniotic membrane containing 0.1% riboflavin and 0.5% moxifloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riboflavin-Moxifloxacin Amniotic Membrane | Combination Product | Patients receiving PACK-CXL therapy with the addition of a specialized amniotic membrane containing 0.1% riboflavin and 0.5% moxifloxacin |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Re-epithelialization | The speed and percentage of the corneal surface healing | Day 28 (week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Pro-inflammatory Cytokine Levels | 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 | Day before intervention (baseline), Day 7, Day 14, Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sardjito General Hospital | Sleman | Special Region of Yogyakarta | 55281 | Indonesia |
IPD will not be shared to protect participant privacy and maintain confidentiality in accordance with the regulations of the local Medical and Health Research Ethics Committee
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| Standard PACK-CXL | Other | Patients receive standard Photo-Activated Chromophore Keratitis-Corneal Cross-linking (PACK-CXL) therapy according to national clinical guidelines |
|