Reliability and Reproducibility of the Eye Check Tonometer

Study Overview
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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.

Official Title
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Reliability and Reproducibility of the Eye Check Tonometer Pressure Measurements as Measured by Patients Reliability and Reproducibility of the Eye Check Tonometer Pressure Measurements as Measured by Patients

Conditions
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Glaucoma, Glaucoma, Suspect

Intervention / Treatment
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* Device: EyeCheck
* Device: Traditional Tonometer (Goldmann and Tonopen)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EyeCheck<br>EyeCheck pressures will be measured with contact lens in place | Device: EyeCheck<br>* EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes.<br>|
| Active Comparator: Traditional Tonometer (Goldmann and Tonopen)<br>Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye). | Device: Traditional Tonometer (Goldmann and Tonopen)<br>* Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure (IOP) measurements | Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen) | Baseline |