Composite Biomarker Visual Function Evaluation for Ocular Treatment Response
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Solution Overview
Problem
There is a need for effective clinical evaluation of disease progression and treatment response in ocular diseases such as Stargardt disease and Age-Related Macular Degeneration (AMD).
Innovation Solution
Methods and systems for treating ocular diseases involve administering a treatment and determining its effectiveness using a composite biomarker calculated from variables related to vision, visual function, ocular anatomy, ocular physiology, and ocular pathology, including multiple assays at different time points to assess therapeutic response and dosage adjustments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple assays are performed to obtain comprehensive variables for disease evaluation, then measurement precision is improved, but device complexity and time consumption increase
Solution Approach 1:
The patent combines multiple separate assays (visual acuity testing, functional visual questionnaire, imaging technology assessments) into a unified composite biomarker evaluation system. This merging approach maintains the comprehensive measurement precision of individual assays while integrating them into a single coordinated system that reduces operational complexity and streamlines the evaluation process.
Solution Approach 2:
The composite biomarker system serves multiple functions simultaneously: it evaluates disease progression, assesses treatment response, monitors visual function, and tracks anatomical changes. This multi-functionality eliminates the need for separate evaluation systems for each parameter, thereby improving measurement precision across all dimensions while reducing overall device complexity.
2Measurement precision
If multiple assays are performed at different time points to monitor treatment response, then measurement precision is improved, but loss of time increases
Solution Approach 1:
The patent establishes baseline composite biomarker values before treatment initiation through comprehensive preliminary assays. This preliminary action creates a reference framework that enables more efficient subsequent evaluations, as follow-up assessments can focus on detecting changes from the established baseline rather than performing complete re-evaluations, thus maintaining precision while reducing time loss.
Solution Approach 2:
The system implements continuous feedback through repeated composite biomarker measurements at scheduled time points. Each measurement provides feedback on treatment efficacy, allowing for real-time monitoring and adjustment. This feedback mechanism maintains high measurement precision through multiple data points while optimizing the evaluation timeline by using the composite nature of the biomarker to reduce individual assessment durations.
3Reliability
If composite biomarker calculation integrates multiple variables from different domains, then reliability of treatment evaluation is improved, but device complexity increases
Solution Approach 1:
The composite biomarker system is segmented into distinct functional modules: visual acuity assessment, functional questionnaire evaluation, imaging analysis, and integrated calculation. Each module independently processes its specific variable type, maintaining reliability through specialized processing while reducing overall system complexity through modular design that allows independent optimization and maintenance of each component.
Solution Approach 2:
The patent creates a composite evaluation system that integrates variables from different domains (visual function, anatomical structure, physiological parameters) into a unified composite biomarker. This composite approach improves reliability by combining multiple independent measurements that collectively provide a more robust assessment of treatment efficacy, while the systematic integration methodology manages the inherent complexity through standardized processing protocols.
Data Source
AI summary
Provided herein is a method of treating a subject with an ocular disease. The method comprises administering to the subject a treatment. The method further comprises determining whether the treatment is therapeutically effective to treat the subject based on a composite biomarker. The composite biomarker is calculated based on at least two variables. At least one of the at least two variables relates to one or more selected from the group comprising vision, visual function, ocular anatomy, ocular physiology, ocular pathology, and a change thereof.