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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Infected Corneal Ulcers trials