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KMID : 1142220220170020183
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Regulatory Research on Food, Drug & Cosmetic
2022 Volume.17 No. 2 p.183 ~ p.191
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Development of Performance Evaluation Method for a Non-contract Tonometer by Utilizing Artificial Eye Phantom
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Cho Han-Saem
Jeoung Sae-Chae
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Abstract
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Glaucoma, which has been known to be closely related to the increment of intraocular pressure (IOP), is a disease that causes vision loss and eventually leads to complete blindness. Therefore, it is essential to maintain good performance of a non-contact tonometer (NCT), which is usually used for measuring IOP as a primary screening of the glaucoma during annual physical examination. Both the national standards and international ones for performance test on the tonometer demand rather large scaled clinical tests on human subjects. It is a timeconsuming and expansive procedure to meet the requirement. To overcome the limitation, we proposed a novel method for evaluating the NCT performance by utilizing an artificial eye phantom, of which mechanical and geometrical characteristics fairly well mimic human subjects. The proposed methods include comparative study between IOP measurement with the testing NCT and those with Goldmann applanation tonometer (GAT), which is currently considered as a gold standard for IOP measurement. The performance evaluation method proposed in this study could be used to profoundly enhance the reliability of IOP readings obtained during a physical examination.
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KEYWORD
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IOP, Tonometer, Performance test, artificial eye phantom, Glaucoma
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