Retrospective Chart Review of Patients With Acanthamoeba Keratitis Who Have Received 0.8 mg/ml Polihexanide

Launched by SIFI SPA · Oct 14, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at patients with a rare eye infection called Acanthamoeba keratitis (AK) who have received a specific treatment known as polihexanide. The study is not giving any new treatments; instead, it is reviewing the medical records of patients who were already treated with this medication as part of a special program to help those in need. The aim is to gather information about how well this treatment worked for these patients.

To be eligible for this study, participants must be over 14 years old and have been diagnosed with Acanthamoeba keratitis using specific tests. They should have started and completed treatment with the 0.8 mg/ml polihexanide between December 1, 2022, and December 31, 2023, and their medical records need to be available for review. There are no specific exclusions, so if someone meets the criteria, they may be included. Participants can expect that researchers will carefully analyze their treatment outcomes at least 30 days after finishing the medication to see how it helped their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>14 years.
• • Clinical signs and symptoms consistent with AK.
• * Identification of Acanthamoeba (diagnostic confirmation of AK) by at least one of the allowed techniques as:
• • Confocal Microscopy
• • PCR,
• • Identification by microbiological culture or cytological smear.
• • Accept to sign the informed consent.
• Additional inclusion criteria:
• • Inclusion in the compassionate use program from 1st December 2022 to 31st December 2023 (date of approval by the local Ethics Committee).
• • Treatment with 0.8 mg/ml polihexanide.
• • End of treatment with 0.8 mg/ml polihexanide.
• • Medical chart available at clinical site.
• • Exclusion Criteria: None