* The primary objective of this study is to evaluate the diagnostic accuracy of the TEMPO (iMOvifa) visual field perimeter screening test by measuring the sensitivity in a population of eyes with glaucoma and the specificity in a population of normal eyes and to measure repeatability of the screening test.
* The secondary objective of this study is to gather and analyze ancillary data to confirm the diagnosis or absence of glaucoma.

Start Date05 Dec 2023

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Cape Fear Eye Institute Llc.

100 Clinical Results associated with Cape Fear Eye Institute Llc.

0 Patents (Medical) associated with Cape Fear Eye Institute Llc.

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Journal of Clinical Medicine

Validation of a Novel Suprathreshold Strategy for Screening Visual Function

Article

Author: Forte, Christina ; Chopra, Reena ; Miranda, Marco A. ; Hou, Huiyuan ; Arias, Juan D. ; Knight, Kristen N. ; Durbin, Mary K. ; Fanelli, James L. ; Ho, Derek Y.

Background/Objectives: Glaucoma, a leading cause of blindness worldwide, is often associated with high intraocular pressure (IOP), which eventually leads to loss of retinal ganglion cells and the retinal nerve fiber layer. Visual field (VF) testing is a principal method of diagnosing and monitoring this disease. Suprathreshold VF test programs are quicker than threshold strategies and are often used as a screening tool. This study evaluates the TEMPO/IMOvifa (Topcon Healthcare/CREWT Medical Systems, Tokyo, Japan), a bilateral standard automated perimeter with a suprathreshold screening program by assessing the sensitivity in a glaucoma cohort and the specificity in a healthy cohort. Methods: All subjects were tested at a single site and underwent a comprehensive ocular examination to categorize them into either a healthy or glaucoma group. As part of the testing procedure, two TEMPO suprathreshold VFs were conducted in sequence and accompanied by a threshold VF test. Results: A total of 193 eyes (randomized study eye) (193 subjects) were evaluated in the final analysis (101 healthy and 92 glaucoma), and average suprathreshold test time (SD) per eye was 39.4 (±4.86) seconds. Specificity was at 91% in the healthy group and sensitivity was at 49% in the glaucoma group. Sensitivity was at 100% when applied to glaucoma cases with an MD of less than −3 dB. Conclusions: The TEMPO screening program demonstrated strong specificity in detecting true healthy cases. It also demonstrated a strong sensitivity when screening mild to moderate glaucoma. Early glaucoma and glaucoma suspects would benefit from complementary modalities such as optical coherence tomography and threshold perimetry to effectively diagnose. Utilizing this screening program in optometric and ophthalmic settings could yield benefits for both the practitioner and the patient.

100 Deals associated with Cape Fear Eye Institute Llc.

100 Translational Medicine associated with Cape Fear Eye Institute Llc.

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