Retrospective Chart Review of Patients With Acanthamoeba Keratitis Who Have Received 0.8 mg/ml Polihexanide as Part of a Compassionate Use Program: A Non-interventional Study With Secondary Use of Data
This will be a non-interventional study with secondary use of data. The study will be a site-based retrospective review of medical chart of patients with AK who initiated and completed a treatment with 0.8 mg/ml polihexanide as part of a compassionate use program. Patientlevel data will be abstracted from medical chart of eligible patients at participating sites and imputed in an electronic case report form (eCRF). Baseline (Time 0) is the date of initiation of 0.8 mg/ml polihexanide. The study period is the period from T0 to the end of treatment. The clinical outcome needs to be confirmed at least 30 days after the conclusion of the treatment.
• 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.