Tear Ferning Test With SK Grading for Early OSD Diagnosis

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Solution Overview

Problem

Current clinical methods for diagnosing ocular surface diseases (OSD) are inadequate for early and precise differentiation, often leading to undiagnosed or undertreated cases due to inaccurate evaluation at early stages, particularly in conditions like dry eye and photokeratitis.

Innovation Solution

The implementation of a tear ferning (TF) test using the Sophie-Kevin (SK) grading criteria for analyzing tear film patterns, which is quick, easy, and cost-effective, allowing for early and differential diagnosis of OSD.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current clinical routine tests (tear volume, TBUT, cornea staining) are used for diagnosis, then the diagnostic process is simple and quick, but the measurement precision and ability to differentiate early OSD is insufficient

Engineering Contradiction:
Improvediagnostic precisionVSAvoidtest complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the tear film into distinct crystalline patterns that can be visualized and graded. By dividing the tear film structure into observable crystalline formations, the test enables precise differentiation of early OSD stages without requiring complex diagnostic equipment.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent utilizes optical interference patterns and color changes in the tear film to indicate different disease states. The crystalline patterns exhibit distinct visual characteristics that correlate with disease severity, enabling precise diagnosis through visual assessment rather than complex instrumentation.

Inventive Principle:
Principle #32Color changes

2Measurement precision

If in vivo confocal microscopy is used for early diagnosis, then the measurement precision improves, but the device complexity and cost increase significantly

Engineering Contradiction:
Improveearly detection capabilityVSAvoidinstrument complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the diagnostic information from complex imaging techniques by focusing specifically on tear film crystalline patterns. This extraction approach captures the essential diagnostic features needed for early OSD detection without requiring the full complexity of in vivo confocal microscopy systems.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent creates a simplified visual copy of the tear film structure through crystalline pattern formation. This pattern serves as a diagnostic surrogate that replicates the essential information needed for early OSD detection, replacing the need for complex imaging equipment while maintaining diagnostic accuracy.

Inventive Principle:
Principle #26Copying

3Reliability

If current clinical tests are used, then the ease of operation is maintained, but the reliability and sensitivity for early OSD diagnosis deteriorates

Engineering Contradiction:
Improvediagnostic reliabilityVSAvoidtest simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent performs preliminary analysis of tear film composition by examining crystalline patterns before more invasive or complex testing is required. This preliminary assessment provides reliable diagnostic information for early OSD detection, maintaining test simplicity while improving diagnostic reliability through enhanced pattern recognition.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent replaces mechanical and instrumental diagnostic systems with an optical-based crystalline pattern analysis method. This substitution maintains the simplicity and ease of operation characteristic of routine tests while significantly improving diagnostic reliability through more sensitive detection of early OSD changes.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The TF test using SK grading provides sensitive and specific differentiation between normal and early photokeratitis status, correlating well with other clinical indicators like tear volume, break-up time, and cornea staining, facilitating timely intervention.

Implementation Method 1

The tear ferning (TF) test is performed by putting a drop of tear sample on a glass slide, allowed for air dry in order to form the TF patterns

Methodology Applied
Scientific EffectEvaporation: Evaporation

Data Source

PatentUS20250384550A1Reagent and kit for identifying and diagnosis ocular surface disease (OSD) and use thereof
Publication Date: 2025.12.18 CHUNG SHAN MEDICAL UNIVERSITY
  • US20250384550A1 patent drawing
  • US20250384550A1 patent drawing
  • US20250384550A1 patent drawing

AI summary

The invention relates to a novel method for precise and early diagnosis to facilitate in time intervention for ocular surface disease (OSD). Therefore, the method is potentially useful for ocular surface disease (OSD) diagnosis in the clinical settings.