An interventional study of IOP with Goldmann Applanation Tonometer and IOP with comparator ORA G3 and ic100 tonometers in Intraocular Pressure and Glaucoma, sponsored by Reichert, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-03.
Sponsored by Reichert, Inc. · Not applicable, Interventional, and Diagnostic
Determine if the Tono-Vera Tonometer accurately measures intraocular pressure (IOP). The hypothesis of this test is to confirm the Tono-Vera Tonometer is equivalent to the Goldmann Applanation Tonometer (within +/- 5.0 mmHg).
The Tono-Vera Tonometer (Reichert, Inc.) is a portable rebound tonometer intended to measure IOP. Subjects will undergo a standard ophthalmologic examination. Subjects will then be measured with four tonometers: Goldmann Applanation Tonometer (C.S.O. SRL), Ocular Response Analyzer G3 (Reichert, Inc.), iCare ic100 tonometer (iCare Finland Oy), and Tono-Vera Tonometer.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 61 is close to the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Reichert, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Measurement of IOP with Goldmann Applanation Tonometer. All subjects will participate in this arm.
Device: IOP with Goldmann Applanation Tonometer
Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers. All subjects will participate in this arm.
Device: IOP with comparator ORA G3 and ic100 tonometers
Measurement of IOP with Tono-Vera Tonometer. All subjects will participate in this arm.
Device: IOP with Tono-Vera Tonometer
Measurement of intraocular pressure (IOP) with Goldmann Applanation Tonometer. Measurement will be used to categorize each subject as having Low IOP (7 to 16 mmHg), Medium IOP (\>16 to \<23 mmHg), or High IOP (\>23 mmHg).
Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers.
Measurement of IOP with Tono-Vera Tonometer
Demonstrate compliance with ANSI Z80.10-2014-Ophthalmics-Ophthalmic Instruments-Tonometers.
Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The Tono-Vera Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.
Time frame: Through study completion, approximately 4 months.
Data collection for two measurement modes.
Tono-Vera has two measurement modes: A 6-measurement mode \& "Quick" measurement mode. The 6-measurement mode will be used during this study. It will be possible to post-process the results to determine the IOP value that would have been obtained using Quick mode. As such the sponsor will be able to ensure the accuracy of both measurement modes compared to Goldmann Tonometry.
Time frame: Through study completion, approximately 4 months.
Data collection for device calibration.
The study will collect data on a large number of patients over a wide range of IOP values. The sponsor may use the collected data in a post-hoc analysis to verify that the Tono-Vera Tonometer factory calibration is optimal.
Time frame: Through study completion, approximately 4 months.
Plan to share: No
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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Reichert, Inc.