Reliability and Reproducibility of the Eye Check Tonometer

NCT04639947 | Terminated Results DMC FDA Device

• 1 other identifier: Pro00106897
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma; Glaucoma, Suspect

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP) Measurements

  Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen)

  Baseline

Study Arms (2)

EyeCheck

EXPERIMENTAL

EyeCheck pressures will be measured with contact lens in place

Device: EyeCheck

Traditional Tonometer (Goldmann and Tonopen)

ACTIVE COMPARATOR

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)

Interventions

EyeCheck DEVICE

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

EyeCheck

Traditional Tonometer (Goldmann and Tonopen) DEVICE

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

Traditional Tonometer (Goldmann and Tonopen)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Dr. Sanjay Asrani
• Organization: Duke Eye Center

sanjay.asrani@duke.edu

+1 919 684 8656

Study Officials

• Sanjay Asrani, MD

  Duke Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: January 6, 2021
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: May 5, 2026
• Results First Posted: October 8, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)