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Comparison of Intraocular Pressure Measurement With the Novel TonoVera Device With Other Commonly Used Devices

Primary Purpose

Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tono-Vera tonometer
Goldman Applanation Tonometry
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glaucoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ability to provide signed and dated informed consent form. Patients willing to comply with all study procedures and be available for the duration of the study.

Male or female patients aged 18 to 99 Patients in good general health as evidenced by ability to come to their appointment on day of study.

Exclusion Criteria:

  • Patients age less than 18 years Patients unable or unwilling to provide informed consent to participate in the study Patients for which an accurate tonometry reading cannot be performed. This may include those with blepharospasm (lid squeezers), nystagmus, extensive corneal pathology, or contact lens wearers who cannot remove their contact lens.Patients with significant scleral thinning Patients with a known allergy to proparacaine or fluorescein as these are used to anesthetize and allow measurement respectively of the eye when used with the Goldmann tonometer.

Sites / Locations

  • Ross Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

IOP Measurement

Arm Description

These are the measurements of the intraocular pressure.

Outcomes

Primary Outcome Measures

Intraocular Pressure
pressure inside the eye

Secondary Outcome Measures

Full Information

First Posted
August 22, 2022
Last Updated
October 13, 2023
Sponsor
State University of New York at Buffalo
Collaborators
Reichert, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05523622
Brief Title
Comparison of Intraocular Pressure Measurement With the Novel TonoVera Device With Other Commonly Used Devices
Official Title
Comparison of Intraocular Pressure Measurement With the Novel TonoVera Device With Other Commonly Used Devices
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
Reichert, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

Brief Summary
We are testing the accuracy of Reichert's Tono-Vera tonometer by comparing measurements of IOP with this device and measurements with other commonly-used tonometers, including Goldmann Applanation and iCare.
Detailed Description
This is a comparative study between the TonoVera, the gold standard Goldmann Applanation Tonometry (GAT) and an established rebound tonometry device, iCare. IOP measurements will be obtained using the following devices: Reichert's prototype Tono-Vera Rebound tonometer (a rebound tonometer in development), iCare's iC100 rebound tonometer (a device commonly used in clinical practice), GAT (a device commonly used in clinical practice). Reichert's iPac Handheld Pachymeter (a device commonly used in clinical practice) will be used to measure the test subject's Central Corneal Thickness (CCT), measured in µm if CCT is not already on file. An Autorefractor Keratometer (ARK) (a device commonly used in clinical practice) will be used to measure necessary vision correction and corneal curvature. The Ocular Response Analyzer (a device commonly used in clinical practice) will be used to measure corneal hysteresis. Multiple IOP measurements will be taken with each device on each eye for all subjects: 3 along the central cornea, 3 along the peripheral cornea, and 3 along the sclera.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
We are comparing the accuracy of eye pressure measurements with a Tono-Vera device compared to the current gold standard, Goldmann Applanation Tonometry.
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IOP Measurement
Arm Type
Other
Arm Description
These are the measurements of the intraocular pressure.
Intervention Type
Device
Intervention Name(s)
Tono-Vera tonometer
Intervention Description
The tonometer measures intraocular pressure with a small rebound probe, similar to those used with other tonometers currently on the market, such as the iCare.
Intervention Type
Device
Intervention Name(s)
Goldman Applanation Tonometry
Intervention Description
This is the current gold standard for measuring eye pressure.
Primary Outcome Measure Information:
Title
Intraocular Pressure
Description
pressure inside the eye
Time Frame
Baseline only

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ability to provide signed and dated informed consent form. Patients willing to comply with all study procedures and be available for the duration of the study. Male or female patients aged 18 to 99 Patients in good general health as evidenced by ability to come to their appointment on day of study. Exclusion Criteria: Patients age less than 18 years Patients unable or unwilling to provide informed consent to participate in the study Patients for which an accurate tonometry reading cannot be performed. This may include those with blepharospasm (lid squeezers), nystagmus, extensive corneal pathology, or contact lens wearers who cannot remove their contact lens.Patients with significant scleral thinning Patients with a known allergy to proparacaine or fluorescein as these are used to anesthetize and allow measurement respectively of the eye when used with the Goldmann tonometer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Sieminski, MD
Phone
716-408-6909
Email
smfernando17@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Seeger, MD
Phone
5859443719
Email
cseeger2@buffalo.edu
Facility Information:
Facility Name
Ross Eye Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Sieminski, MD
Phone
716-881-7900

12. IPD Sharing Statement

Citations:
PubMed Identifier
31726999
Citation
Chen M, Zhang L, Xu J, Chen X, Gu Y, Ren Y, Wang K. Comparability of three intraocular pressure measurement: iCare pro rebound, non-contact and Goldmann applanation tonometry in different IOP group. BMC Ophthalmol. 2019 Nov 14;19(1):225. doi: 10.1186/s12886-019-1236-5.
Results Reference
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PubMed Identifier
18703945
Citation
Hager A, Loge K, Schroeder B, Fullhas MO, Wiegand W. Effect of central corneal thickness and corneal hysteresis on tonometry as measured by dynamic contour tonometry, ocular response analyzer, and Goldmann tonometry in glaucomatous eyes. J Glaucoma. 2008 Aug;17(5):361-5. doi: 10.1097/IJG.0b013e31815c3ad3. Erratum In: J Glaucoma. 2008 Oct-Nov;17(7):604. Annette, Hager [corrected to Hager, Annette]; Kristina, Loge [corrected to Loge, Kristina]; Bernd, Schroeder [corrected to Schroeder, Bernd]; Mark-Oliver, Fullhas [corrected to Fullhas, Mark-Oliver]; Wolfgang, Wiegand [corrected to Wiegand, Wolfgang].
Results Reference
background
PubMed Identifier
22310080
Citation
Kaushik S, Pandav SS, Banger A, Aggarwal K, Gupta A. Relationship between corneal biomechanical properties, central corneal thickness, and intraocular pressure across the spectrum of glaucoma. Am J Ophthalmol. 2012 May;153(5):840-849.e2. doi: 10.1016/j.ajo.2011.10.032. Epub 2012 Feb 4.
Results Reference
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Comparison of Intraocular Pressure Measurement With the Novel TonoVera Device With Other Commonly Used Devices

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