Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07559149
PHASE2

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

Sponsor: Gadjah Mada University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2024-07-07

Completion Date

2025-08-14

Last Updated

2026-04-30

Healthy Volunteers

No

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

Locations (1)

Dr. Sardjito General Hospital

Sleman, Special Region of Yogyakarta, Indonesia