Back to resultsReliability and Reproducibility of the Eye Check Tonometer (EyeCheck)
Primary Purpose
Glaucoma, Glaucoma, Suspect
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EyeCheck
Traditional Tonometer (Goldmann and Tonopen)
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma
Eligibility Criteria
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
Sites / Locations
- Duke Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EyeCheck
Traditional Tonometer (Goldmann and Tonopen)
Arm Description
EyeCheck pressures will be measured with contact lens in place
Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye).
Outcomes
Primary Outcome Measures
Intraocular pressure (IOP) measurements
Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04639947
Brief Title
Reliability and Reproducibility of the Eye Check Tonometer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to low accrual
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
December 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Suspect
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EyeCheck
Arm Type
Experimental
Arm Description
EyeCheck pressures will be measured with contact lens in place
Arm Title
Traditional Tonometer (Goldmann and Tonopen)
Arm Type
Active Comparator
Arm Description
Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye).
Intervention Type
Device
Intervention Name(s)
EyeCheck
Intervention Description
EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes.
Intervention Type
Device
Intervention Name(s)
Traditional Tonometer (Goldmann and Tonopen)
Intervention Description
Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.
Primary Outcome Measure Information:
Title
Intraocular pressure (IOP) measurements
Description
Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen)
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Asrani, MD
Organizational Affiliation
Duke Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Currently, there is no plan to share data with other researchers.
Learn more about this trial
Reliability and Reproducibility of the Eye Check Tonometer
We'll reach out to this number within 24 hrs