Background and Clinical Importance Acute invasive fungal sinusitis (AIFS) is a rapidly progressive, potentially life-threatening infection that primarily affects immunocompromised hosts[1]. The disease is characterized by fungal invasion of sinonasal mucosa, submucosa, blood vessels and bone, frequently resulting in local tissue necrosis. When fungal invasion extends to the orbit and the visual apparatus, patients can develop sight-threatening and life-threatening complications such as orbital cellulitis, orbital apex syndrome, cavernous sinus thrombosis, central retinal artery occlusion, optic nerve infarction, and globe necrosis[2]. Visual and orbital involvement significantly increases morbidity and mortality, and often necessitates aggressive medical and surgical management including high-dose systemic antifungals, orbital debridement, or even exenteration[3]. The COVID-19 pandemic (beginning 2019–2020) precipitated a notable rise in cases of mucormycosis, an angioinvasive fungal infection notorious for its predilection for sinonasal and orbital tissues[4]. Multiple factors associated with COVID-19—systemic corticosteroid use, uncontrolled diabetes mellitus, immune dysregulation, prolonged hospitalization and oxygen therapy—have been implicated in increased susceptibility to mucormycosis. COVID-associated mucormycosis (CAM) often presents as rhino-orbital or rhino-orbito-cerebral disease and is frequently complicated by rapid orbital invasion and vision loss[5]. The surge of CAM cases globally, particularly in certain regions, highlighted knowledge gaps regarding risk factors, clinical course, optimal timing and extent of surgical intervention, and visual prognosis. Epidemiology and time trends (2000–2025) Prior to the COVID-19 pandemic, AIFS (including mucormycosis and invasive aspergillosis) was considered uncommon but well-recognized among patients with diabetes, hematologic malignancy, organ transplantation, and other immunosuppressive states. Reported incidence varies by geography, underlying comorbidities and local diagnostic vigilance. From 2020 onwards, many centers reported clusters of CAM cases, with higher incidence in regions with high diabetes prevalence and widespread corticosteroid use in COVID care[6,7]. Examining the literature from 2000 through 2025 allows assessment of baseline epidemiology, shifts in fungal aetiologies and case- mix over time, and the specific impact of the COVID-19 era on orbital and visual outcomes. Pathophysiology linking sinus disease to orbital and visual complications The anatomic proximity between the paranasal sinuses and the orbit—separated by thin bony walls and multiple vascular and perivascular channels—permits rapid contiguous spread. Angioinvasion by organisms such as Mucorales leads to arterial thrombosis, tissue ischemia and necrosis, and can cause optic nerve ischemia or direct fungal invasion. Extension through ethmoidal foramina, lamina papyracea erosion, perivascular channels, and via the orbital apex can lead to cranial neuropathies, cavernous sinus thrombosis and intracranial spread[8]. Host factors (e.g., hyperglycemia, acidosis, neutropenia) and iatrogenic factors (corticosteroids, broad-spectrum antibiotics) further impair host defenses and facilitate fulminant progression. Clinical presentation and ophthalmic manifestations Visual and orbital complications encompass a broad clinical spectrum. Early signs may include periorbital swelling, erythema, pain, proptosis, ophthalmoplegia, chemosis and decreased visual acuity. Progression can culminate in optic neuropathy due to compressive, ischemic or infiltrative mechanisms, retinal vascular occlusions, and panophthalmitis. Orbital apex syndrome— marked by visual loss, afferent pupillary defect, and multiple cranial nerve palsies—signals advanced disease and portends poor visual prognosis[9]. Distinguishing fungal from bacterial or inflammatory orbital disease on clinical grounds alone can be difficult; hence rapid radiologic assessment and tissue diagnosis are critical. Diagnostic evaluation: imaging and microbiology Early diagnosis relies on a high index of suspicion. Contrast-enhanced CT delineates bony erosion and sinus opacification; MRI is superior for soft tissue delineation, perineural spread and orbital apex/ intracranial involvement10]. Characteristic radiologic features of invasive fungal disease include rapid soft-tissue invasion, non-enhancing devitalized tissue (black turbinate sign), vascular occlusion and bone destruction. Definitive diagnosis requires histopathologic demonstration of hyphal invasion and/or culture identification. Molecular diagnostics and fungal PCR assays have emerged but vary in availability and sensitivity across centers. Management principles and outcomes affecting vision Management of AIFS with orbital involvement is multimodal: prompt correction of underlying risk factors (strict glycemic control, reversal of immunosuppression where possible), urgent initiation of systemic antifungal therapy (liposomal amphotericin B and step-down agents as indicated), and timely surgical debridement of necrotic tissue[11]. Decisions regarding orbital- sparing surgery versus orbital exenteration are complex and influenced by extent of disease, systemic status, and potential for visual recovery. Despite aggressive therapy, visual outcomes remain poor in a significant proportion of patients—an outcome that has profound functional and psychosocial consequences. Rationale for a systematic review and meta- analysis Although multiple case series, institutional cohorts and narrative reviews have described visual and orbital complications of AIFS, the literature is heterogeneous with variable definitions, outcome measures, and follow-up durations. The explosive rise in COVID-associated mucormycosis introduced a large, more recent dataset—but with diverse clinical practices during the pandemic surge. A formal systematic review and meta-analysis covering studies published from 2000 through 2025 will: (1) quantify pooled incidence rates of orbital and visual complications across different clinical settings and time periods; (2) compare outcomes and prognostic factors before and during the COVID-19 era; (3) evaluate the influence of interventions (timing of surgery, antifungal regimens) on vision-saving outcomes; and (4) identify gaps in the literature and standardize outcome reporting for future research. Objectives 1. To synthesize published evidence (2000–2025) on the frequency and spectrum of visual and orbital complications in acute invasive fungal sinusitis, including COVID-associated mucormycosis. 2. To estimate pooled rates of key outcomes (e.g., blindness, need for exenteration, orbital apex syndrome, mortality) and assess heterogeneity by geography, underlying comorbidity and time period (pre-COVID vs COVID era). 3. To identify clinical, radiologic and management- related prognostic factors associated with poor visual outcomes. 4. To provide evidence-based recommendations for early recognition, diagnostic pathways, and therapeutic strategies aimed at preserving vision. Scope and definitions For the purposes of this review, “acute” refers to clinically rapidly progressive invasive fungal rhinosinusitis with onset over days to weeks requiring urgent intervention. Visual outcomes will include objective measures (visual acuity, visual field findings) and functional endpoints (legal blindness, globe loss). Orbital complications will be categorized to include orbital cellulitis, orbital abscess, orbital apex syndrome, cranial neuropathies and orbital necrosis requiring debridement or exenteration[12].

1. Protocol and reporting standards The review protocol was developed a priori following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol was registered in PROSPERO . Any deviations from the protocol are reported in the final manuscript. 2. Eligibility criteria Studies were eligible according to the PICOS framework: Population: Patients of any age diagnosed with acute invasive fungal rhinosinusitis (including mucormycosis, invasive aspergillosis and other invasive fungal sinusitis) presenting with visual and/or orbital complications. Studies reporting COVID-19–associated mucormycosis (CAM) were included in a COVID-specific subgroup. Intervention/Exposure: Not applicable for inclusion (observational and interventional studies reporting visual/orbital outcomes were included). Comparators: Where available, studies comparing COVID-associated cases to non-COVID cases, or different management approaches, were included in subgroup analyses. Outcomes: Primary outcomes were the presence and proportion of visual loss (complete or partial), optic neuropathy, orbital cellulitis, orbital apex syndrome, extraocular muscle palsy, globe involvement, and orbital exenteration. Secondary outcomes included timing of ocular/orbital involvement, radiological findings, microbiological aetiology, management (surgical and medical), all- cause mortality, and length of follow-up. Study design: Randomized controlled trials, cohort studies (prospective and retrospective), case– control studies, cross-sectional studies, case series (≥3 patients), and case reports were considered for qualitative synthesis. For quantitative meta- analysis of proportions, only studies with ≥5 patients reporting extractable numerical data on ocular/orbital outcomes were pooled. Reviews, editorials, conference abstracts without full data, and non-human studies were excluded. 3. Information sources and search strategy A comprehensive electronic search was conducted for articles published between January 1, 2000 and - MEDLINE (via PubMed) - Embase - Scopus - Web of Science - Cochrane CENTRAL - Google Scholar (first 200 hits screened for grey literature) Reference lists of included studies and relevant reviews were hand-searched for additional eligible records. Clinical trial registries (ClinicalTrials.gov and WHO ICTRP) were searched for ongoing or unpublished studies. Authors of studies with incomplete outcome reporting were contacted by e-mail to request missing data where feasible. A sample search strategy for PubMed (adapted to other databases using equivalent subject headings) combined controlled vocabulary (MeSH/Emtree) and free-text terms: (("Fungal Sinusitis"[Mesh] OR mucormycosis OR mucor OR mucormycetes OR "zygomycosis" OR aspergillus OR "invasive fungal" OR "invasive fungal sinusitis") AND ("Orbit" OR orbital OR ocular OR eye OR vision OR visual OR optic OR optic nerve OR ophthalmoplegia OR exenteration OR ophthalmic)) AND (2000:2025[dp]) For COVID-19–associated cases an additional search string included: (COVID-19 OR SARS-CoV-2 OR coronavirus). Search strategies for each database and full search log (dates searched, number of hits per database) are reported in the supplementary material. 4. Study selection Records retrieved from all searches were exported into reference management software (EndNote/Zotero) and duplicates were removed. Screening and selection occurred in two stages: title/abstract screening followed by full-text review. Two reviewers (Reviewer A and Reviewer B) independently screened titles and abstracts for eligibility. Studies meeting inclusion criteria or with unclear eligibility proceeded to full-text review by the same two reviewers. Disagreements at either stage were resolved by discussion and consensus, or by consulting a third reviewer (Reviewer C) when consensus could not be reached. A PRISMA flow diagram was used to document the number of records identified, screened, excluded, and included. 5. Data extraction and management A standardized data extraction form was developed and piloted on a sample of included studies. Two reviewers independently extracted data; discrepancies were resolved by consensus. Extracted data items included (where reported): - Study identifiers: first author, year, country, setting, study design, single vs multicentre - Patient characteristics: sample size, age (mean/median), sex, comorbidities (diabetes mellitus, immunosuppression, corticosteroid use), COVID-19 status and timing relative to fungal diagnosis - Diagnostic criteria: microbiological confirmation (culture/histopathology/PCR), imaging modalities used (CT/MRI) and diagnostic definitions across studies prior to pooling. Visual loss was categorized as: - Complete visual loss (no light perception) - Severe visual impairment (counting fingers to hand movements) - Partial visual loss (reduction in acuity not classified as complete) When studies used different or non-standard categories, original study categories were mapped to the above definitions where possible; otherwise data were reported narratively. 7. Risk of bias and quality assessment Risk of bias for included studies was assessed independently by two reviewers. For observational cohort and case-control studies, the Newcastle-Ottawa Scale (NOS) was used, scoring selection, comparability and outcome/exposure ascertainment domains. For cross-sectional studies the Joanna Briggs Institute (JBI) checklist for analytical cross-sectional studies was applied. For case series and case reports the JBI critical appraisal tools for case series/case reports were used. - Fungal aetiology: species identified (Mucorales, Each study received an overall judgement Aspergillus spp., others) (low/moderate/high risk of bias) according to - Visual and orbital outcomes: number and proportion with visual loss (complete or partial), optic neuropathy, orbital cellulitis, orbital apex predefined thresholds. Disagreements resolved by discussion or by a third reviewer. 8. Data synthesis and statistical analysis were syndrome, extraocular muscle palsy, globe Quantitative synthesis (meta-analysis) was involvement, orbital exenteration, laterality performed where ≥3 clinically and - Timing: onset of ocular/orbital symptoms relative to sinus diagnosis or COVID-19 - Management: antifungal therapy (agent, dose, duration), surgical interventions (functional endoscopic sinus surgery, debridement, exenteration), adjunctive therapies - Outcomes: mortality, visual outcome at last follow-up, complications, length of follow-up - Study quality/risk of bias judgments and notes on missing data If data were only presented in figures, attempts were made to extract values using digital extraction tools. Where necessary, authors were contacted to request clarification or raw data. 6. Outcome definitions and data harmonization Primary outcome definitions were harmonized methodologically comparable studies reported the same outcome with extractable data. Primary meta-analysis: pooled proportions for ocular and orbital complications (e.g., proportion with any visual loss, proportion undergoing exenteration) were calculated using random- effects models to account for between-study heterogeneity. Statistical methods and transformations: - Proportions were stabilized using the Freeman– Tukey double-arcsine transformation prior to pooling and back-transformed for presentation. - Random-effects pooling was performed primarily with the DerSimonian–Laird estimator; sensitivity analyses used the restricted maximum likelihood (REML) estimator and the Hartung–Knapp adjustment for confidence intervals. - Heterogeneity was quantified using Cochran’s Q and the I² statistic, with I² values interpreted as low (25–49%), moderate (50–74%), and high (≥75%). - Where appropriate, pooled odds ratios (ORs) or risk ratios (RRs) were calculated for comparative studies reporting binary outcomes. Subgroup and meta-regression analyses: - Prespecified subgroup analyses: COVID- associated vs non-COVID cases; geographic region (continent); study design (prospective vs retrospective); publication period (2000– 2019 vs 2020–2025); severity of comorbidities (proportion with diabetes ≥ median vs < median). - Meta-regression was performed (when ≥10 studies available) to explore the influence of mean age, proportion with diabetes, and steroid exposure on pooled proportions. publication bias. A GRADE summary of findings table was prepared for primary outcomes. 11. Declarations Ethics: As this study used published aggregate data, no institutional review board approval or patient consent was required. Funding and conflicts of interest: Sources of funding for the review and potential conflicts of interest for the review team were declared in the manuscript. Individual included studies’ funding sources and conflicts were recorded in the data extraction form. 12. Supplementary materials and reproducibility A full search log (database-specific search strings and dates), the PRISMA flow diagram, data extraction templates, risk of bias assessments, analysis code (R scripts), and any correspondence with study authors will be provided as Sensitivity analyses: leave-one-out influence supplementary files to ensure transparency and analysis and exclusion of high risk-of-bias studies. reproducibility. Small-study effects/publication bias: visually 13. Information Sources and Search Strategy assessed with funnel plots for outcomes with ≥10 studies and tested using Egger’s regression test for continuous/logit transformed outcomes or Peters’/Harbord’s test for proportions when appropriate. Statistical software: analyses were conducted in R (version 4.x) using the 'meta' and 'metafor' packages (exact version numbers and session information to be reported in the supplementary material). RevMan (Cochrane) was used for data presentation where appropriate. 9. Handling of missing data When key data elements (e.g., event counts, denominators) were missing, attempts were made to calculate them from available information (e.g., reported percentages, sample sizes). If this was not possible, authors were contacted for missing data. Studies with irretrievable critical data were included in qualitative synthesis but excluded from meta-analysis. 10. Assessment of certainty of evidence The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence for pooled outcomes, considering risk of bias, inconsistency, indirectness, imprecision, and (Expanded) Databases Searched (2000–2025): - MEDLINE (PubMed) - Embase - Scopus & Web of Science - Cochrane CENTRAL - Google Scholar (first 200 hits screened for grey literature) - Clinical Trial Registries (ClinicalTrials.gov and WHO ICTRP) Example PubMed Search Strategy: (("Fungal Sinusitis"[Mesh] OR mucormycosis OR mucor OR zygomycosis OR aspergillus OR "invasive fungal sinusitis") AND ("Orbit" OR orbital OR ocular OR eye OR vision OR visual OR optic OR optic nerve OR ophthalmoplegia OR exenteration)) AND ("2000/01/01"[Date - Publication] : "2025/12/31"[Date - Publication]) COVID-19–associated mucormycosis search addition: AND (COVID-19 OR SARS-CoV-2 OR coronavirus) Search Process: - Searches were performed independently by two reviewers. - Search results exported to EndNote for deduplication. - PRISMA flow diagram documents the number of studies identified, screened, excluded, and included. Example of Study Selection: - Records identified: 1,245 - Duplicates removed: 215 - Records screened: 1,030 - Full-text assessed: 182 - Studies included in qualitative synthesis: 85 - Studies included in quantitative meta-analysis: 56

14. Data Extraction and Management (Expanded with Form) Data Extraction Template (Piloted Form): Management Antifungal therapy, surgical interventions, adjunctive therapy Outcomes Mortality, visual outcome at last follow- up, complications Risk of bias Newcastle–Ottawa Scale / JBI scoring Two reviewers independently extracted data. Disagreements were resolved by consensus or a third reviewer. Extracted data were cross- checked with figures and supplementary files; authors were contacted for missing information. PRISMA 2020 Checklist (Abbreviated for Methods Section) Section Item Description Title 1 Identify the report as a systematic review and/or meta-analysis Abstract 2 Structured summary following PRISMA abstract checklist Introduction 3-4 Rationale, objectives Methods 5 Eligibility criteria (PICOS) Methods 6 Information sources (databases, date ranges) Methods 7 Search strategy (detailed string per database) Methods 8 Selection process (number of reviewers, consensus) Methods 9 Data collection process (independent extraction, piloted form) Methods 10 Data items (outcomes, exposures, demographics) Methods 11 Risk of bias assessment (NOS/JBI tools) Methods 12 Effect measures and synthesis methods (meta- analysis details) Results 17 Study selection numbers (PRISMA flow diagram) Results 18 Characteristics of included studies Results 19 Risk of bias in studies Discussion 23 Limitations, interpretation, evidence certainty (GRADE)

Overview of Acute Fungal Sinusitis and Orbital Complications Acute fungal sinusitis (AFS) encompasses a spectrum of fungal infections affecting the paranasal sinuses. Among these, invasive fungal rhinosinusitis (IFRS) is particularly concerning due to its aggressive nature and potential to cause significant morbidity and mortality[13]. Orbital complications are among the most common and severe manifestations of IFRS, often leading to vision impairment or loss if not promptly diagnosed and treated[14]. A multi-institutional study reviewed 59 cases of IFRS and found that 44.1% presented with orbital complications[15]. The most frequent symptoms included periorbital swelling, proptosis, ptosis, and visual disturbances. The study also highlighted that mucormycosis was more commonly associated with orbital involvement compared to aspergillosis. COVID-19–Associated Mucormycosis and Its Impact on Orbital Structures The COVID-19 pandemic has led to an unprecedented surge in cases of mucormycosis, particularly in patients with uncontrolled diabetes mellitus and those receiving high-dose corticosteroids[16]. These factors contribute to a compromised immune system, creating an environment conducive to fungal infections. A systematic review of 476 cases of mucormycosis associated with COVID-19 revealed that 346 patients were COVID-19 positive. Among these, 67.01% had diabetes mellitus, and 57.77% had received corticosteroid therapy[17]. The mortality rate was reported at 36.34%. Orbital complications in COVID-19–associated mucormycosis (CAM) are particularly devastating. Imaging studies have shown involvement of the posterior ethmoid and sphenoid sinuses, with subsequent extension to the orbit[18]. This can lead to conditions such as subperiosteal orbital abscesses, cavernous sinus thrombosis, and craniofacial osteomyelitis. Risk Factors and Predictive Indicators Several factors have been identified that increase the risk of developing orbital complications in AFS: - Delayed Diagnosis and Treatment: A longer interval between symptom onset and surgical intervention is associated with worse outcomes. - Underlying Medical Conditions: Conditions such as diabetes mellitus, immunosuppressive therapy, and hematologic malignancies predispose individuals to fungal infections. - Clinical Symptoms: Early signs like facial pain, blurred vision, and periorbital swelling should raise suspicion for orbital involvement. A study by Chiang et al. emphasized that a higher white blood cell count and absolute neutrophil count were observed in patients with orbital complications, suggesting a more aggressive inflammatory response[19]. Management Strategies The management of AFS with orbital complications requires a multidisciplinary approach: - Early Surgical Intervention: Prompt surgical debridement is critical to control the spread of infection and prevent further complications. - Antifungal Therapy: Systemic antifungal agents, such as amphotericin B, are the mainstay of treatment. - Supportive Care: Management of underlying conditions, such as glycemic control in diabetic patients, is essential to improve outcomes. A study by Meher et al3. from a dedicated COVID hospital in Delhi highlighted the importance of early diagnosis and aggressive management in reducing mortality rates associated with CAM. Prognosis and Outcomes The prognosis of patients with AFS and orbital complications depends on several factors: - Timeliness of Treatment: Early intervention significantly improves survival rates. - Extent of Disease: The involvement of adjacent structures like the brain or cavernous sinus worsens the prognosis. - Patient's Overall Health: Comorbidities such as uncontrolled diabetes and immunosuppression adversely affect outcomes. In the context of COVID-19, the emergence of CAM has posed additional challenges. A study by Trehan et al. discussed the increased incidence of rhino- orbital-cerebral mucormycosis during the pandemic and emphasized the need for heightened awareness and early intervention[20].

Acute invasive fungal rhinosinusitis (AIFRS), particularly in the context of COVID-19, has emerged as a significant clinical concern due to its rapid progression and devastating complications. Orbital involvement is among the most common and severe manifestations, with studies indicating an incidence ranging from 23.7% to 49.6% in AIFRS patients. The COVID-19 pandemic has exacerbated this issue, with a notable increase in cases, especially among diabetic individuals and those receiving corticosteroid therapy. The pathophysiology of orbital complications in AIFRS involves the angioinvasive nature of fungi like Mucor and Aspergillus, leading to thrombosis, necrosis, and potential spread to adjacent structures. Clinical manifestations include ptosis, proptosis, chemosis, ophthalmoplegia, and visual disturbances. Diagnostic modalities such as contrast-enhanced CT and MRI play a crucial role in early detection, while histopathological examination and fungal cultures confirm the diagnosis. Management strategies encompass prompt surgical debridement, antifungal therapy (commonly Amphotericin B), and in some cases, adjunctive therapies like hyperbaric oxygen. FUTURE RECOMMENDATIONS 1. Enhanced Surveillance and Early Detection: Implement routine screening for AIFRS in high-risk populations, particularly post-COVID-19 patients with diabetes mellitus, to facilitate early intervention. 2. Standardized Protocols: Develop and disseminate standardized clinical guidelines for the diagnosis and management of AIFRS to ensure consistency and improve patient outcomes. 3. Multidisciplinary Approach: Encourage collaboration among otolaryngologists, ophthalmologists, infectious disease specialists, and intensivists for comprehensive care and better prognostication. 4. Research and Education: Invest in research to understand the pathogenesis of AIFRS and educate healthcare professionals about its early signs to reduce morbidity and mortality. Clinical Implications Clinicians should maintain a high index of suspicion for AIFRS in patients presenting with acute sinusitis symptoms, especially those with a recent history of COVID-19, diabetes, or corticosteroid use. Early recognition and aggressive management are paramount to prevent irreversible visual and orbital sequelae. Given the potential for rapid deterioration, timely referral to specialized centers equipped with advanced imaging and surgical facilities is recommended.

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