Reliability and Reproducibility of the Eye Check Tonometer

Glaucoma Clinical Trial

— EyeCheck  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04639947
• Other study ID #: Pro00106897
• Status: Terminated
• Phase: N/A
• Start date: January 6, 2021
• Est. completion date: December 2, 2021

Study information

• Verified date: November 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2, 2021
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Suspect
• Ocular Hypertension

Intervention

Device:
• EyeCheck
EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes.
• Traditional Tonometer (Goldmann and Tonopen)
Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.

Locations

Country	Name	City	State
United States	Duke Eye Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure (IOP) measurements	Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen)	Baseline