Reliability and Reproducibility of the Eye Check Tonometer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-06

Study Completion Date

2021-12-02

Brief Summary

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To investigate whether the new applanation tonometer (EyeCheck monitor) can provide intraocular pressure (IOP) measurements comparable to those of traditional tonometers such as the Goldmann applanation tonometer and the Tonopen.

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Detailed Description

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Conditions

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Glaucoma Glaucoma, Suspect

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

All subjects will first take their pressure using the EyeCheck with contact lens in and then remove their lens have pressures taken with Goldmann and Tonopen (two standard of care techniques of taking pressures of the eyes).

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EyeCheck

EyeCheck pressures will be measured with contact lens in place

Group Type EXPERIMENTAL

EyeCheck

Intervention Type DEVICE

EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes.

Traditional Tonometer (Goldmann and Tonopen)

Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye).

Group Type ACTIVE_COMPARATOR

Traditional Tonometer (Goldmann and Tonopen)

Intervention Type DEVICE

Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.

Interventions

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EyeCheck

EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes.

Intervention Type DEVICE

Traditional Tonometer (Goldmann and Tonopen)

Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age of 18 years or older,
* Any glaucoma patient or glaucoma suspect patient
* Presents for an appointment wearing their own soft contact lens.

Exclusion Criteria

* Arthritis affecting the upper extremity in the patient or caregiver
* Patient unwilling or assessed to be unable to comply with the study protocol
* Any corneal abnormalities such as opacities, scars, Fuchs dystrophy, map dot fingerprint dystrophy, history of recurrent corneal abrasion, corneal surgery such as Lasik, PRK, DSAEK, transplant or implant
* History of any ongoing ocular symptoms such as eye pain or redness or discharge
* History of recent ocular surgery (done in the past 3 months)
* History of a any filtering or tube surgery for glaucoma (to reduce risk of infection associated complications)
* Recent eye infection (within the past 3 months)
* History of diabetes for \> 5 years duration
* Monocular patient
* Best corrected visual acuity\< 20/70
* Head or hand tremors

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No