Here is a full summary of what the protocol contains, following the SHSRC template structure exactly:
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Introduction - Background on firecracker ocular trauma epidemiology (India focus), corneal anatomy, injury mechanisms, gap analysis, and rationale ending with the study aim
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Study Hypothesis - H1 and H0 stated
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Aim and Objectives - Single aim + 2 primary (clinical spectrum, visual outcomes) + 5 secondary objectives (demographics, BETT/OTS classification, management, predictors, complications)
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Materials and Methods - Prospective observational longitudinal design; full device/equipment list with government supply declaration; 18-month timeline
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Sample Selection - Sample size n=100 calculated from Kurien et al. (2020), using OpenEpi; consecutive sampling; detailed inclusion/exclusion criteria
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Study Variables / Outcomes / Endpoints - Formatted 3-column table aligned to each objective
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Data Collection - 10-step chronological flowchart (Day 0 through 3 months); detailed BETT + OTS classification protocol; full medical and surgical management protocol
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Data Management Plan - Paper CRF + Excel master chart; SPSS v26 analysis; paired t-test/logistic regression plan; complete 19-variable data codebook table
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References - 10 Vancouver-format citations
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Ethics Considerations - ICMR 2017 guidelines adherence; voluntary participation; assent for minors; LAR consent
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Gantt Chart - 12-quarter timeline table (3 years)
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Undertaking - With AI non-use declaration