Retrospective Chart Review of Patients With Acanthamoeba Keratitis Who Have Received 0.8 mg/mL Polihexanide as Part of the "Medicines in Special Situations" (Medicamentos en Situaciones Especiales) Program in Spain.
SIFI SpA
24 participants
Oct 30, 2025
OBSERVATIONAL
Conditions
Summary
The study will be a multicentric, retrospective, non-interventional medical chart review of patients with AK who initiated a treatment with 0.8 mg/ml polihexanide as part of the Spanish Medicines in Special Situations program, whether they fully completed the treatment or not. Baseline date is defined as the date of 0.8 mg/ml polihexanide initiation. The Study Period for each patient will be considered the period from the baseline to the conclusion of the treatment.
Eligibility
Inclusion Criteria5
- Participation in the Spanish Medicines in Special Situations (Gestión de Medicamentos en Situaciones Especiales) program from August 2022 to 31 October 2024, because they presented clinical signs and symptoms consistent with AK and the identification of Acanthamoeba was confirmed by at least one of the following techniques:
- o Confocal Microscopy o PCR o Identification by microbiological culture or cytological smear.
- Diagnosis of AK at least 2 months before inclusion in the study
- Age ≥12 years at the time of diagnosis.
- To have started and completed the treatment with 0.8 mg/ml polihexanide at the moment of the inclusion.
Exclusion Criteria1
- No participation in another trial contemporary at this one
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Interventions
The study population for this study is patients diagnosed with AK treated with 0.8 mg/ml polihexanide as part of the Spanish Medicines in Special Situations program.
Locations(5)
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NCT07195864