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

NCT07559149 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

  • Infected Corneal Ulcers
  • CXL

Interventions

COMBINATION_PRODUCT

Riboflavin-Moxifloxacin Amniotic Membrane

Patients receiving PACK-CXL therapy with the addition of a specialized amniotic membrane containing 0.1% riboflavin and 0.5% moxifloxacin

OTHER

Standard PACK-CXL

Patients receive standard Photo-Activated Chromophore Keratitis-Corneal Cross-linking (PACK-CXL) therapy according to national clinical guidelines

Sponsors & Collaborators

  • Gadjah Mada University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-07
Primary Completion
2025-02-13
Completion
2025-08-14

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07559149 on ClinicalTrials.gov