A Longitudinal Analysis Of Healing Outcomes In Fungal Corneal Ulcers: Impact Of Clinical Characteristics, Etiological Agents, Biofilm Formation, And Fks1 Gene Profile Of Clinical Isolates

Fungal corneal ulcer is a major cause of visual impairment in developing countries, with a high prevalence in Indonesia. Clinical factors, fungal etiology, and biofilm formation are known to influence prognosis; however, updated epidemiological and microbiological data in Indonesia remain limited. This study aims to evaluate the associations between demographic, clinical, and etiological factors, biofilm formation, genetic diversity, and antifungal susceptibility with healing outcomes of fungal corneal ulcers, including the role of the FKS1 gene in biofilm formation.

This multicentre prospective cohort study will be conducted at JEC Eye Hospitals & Clinics and Cipto Mangunkusumo Hospital, Indonesia. Ethical approval has been obtained. Patient recruitment will begin in February 2026, with study completion and results expected by August 2026.

This is a single-blinded prospective cohort study. Patients with fungal corneal ulcers will undergo comprehensive clinical examination, fungal culture, biofilm assays using crystal violet staining, XTT  tests, and analysis of the FKS1 gene using RT-qPCR and Sanger sequencing. Subjects will be followed for six weeks to assess healing outcomes, including time to re-epithelialization, scar formation, visual acuity, complications, and antifungal susceptibility (MIC, MBIC, and MBEC). Statistical analyses will include Chi-square or Fisher’s exact tests for categorical variables; t-test, one-way ANOVA, Mann–Whitney, or Kruskal–Wallis tests for numerical variables; and Cox proportional hazards regression for re-epithelialization time.

This study is expected to generate updated epidemiological data on fungal corneal ulcers in Indonesia, including etiological distribution, biofilm formation, antifungal susceptibility profiles, and their relationship with clinical healing outcomes. In addition, the genetic diversity of fungal pathogens and the expression of the FKS1 gene will be investigated through in vitro studies to evaluate their association with fungal biofilm formation.

The integration of clinical, microbiological, and molecular data is expected to identify predictors of fungal corneal ulcer healing, strengthen the understanding of resistance mechanisms, and provide a foundation for the development of more effective and targeted therapies.

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