Reliability and Reproducibility of the Eye Check Tonometer

Not Applicable

Terminated

• Conditions: Glaucoma; Glaucoma, Suspect
• Interventions: Device: Traditional Tonometer (Goldmann and Tonopen); Device: EyeCheck

• Registration Number: NCT04639947
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-23
• Study Start: 2021-01-06
• Primary Completion: 2021-12-02
• Study Completion: 2021-12-02
• Disposition First Submitted: 2022-11-03
• Results First Submitted: 2023-07-06
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Results First Posted: 2024-10-08
• Disposition First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Tonometer (Goldmann and Tonopen)	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).
EyeCheck	EyeCheck	EyeCheck pressures will be measured with contact lens in place

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) Measurements	Baseline	Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen)

Trial Locations

Locations (1)

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States