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EyeCheck: Reliability and Reproducibility of the Eye Check Tonometer

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04639947
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
17.8
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: EyeCheck
  • Device: Traditional Tonometer (Goldmann and Tonopen)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Jan 6, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: EyeCheck

EyeCheck pressures will be measured with contact lens in place

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

Device: Traditional Tonometer (Goldmann and Tonopen)
Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.

Outcome Measures

Primary Outcome Measures

  1. Intraocular pressure (IOP) measurements [Baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke Eye Center Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Sanjay Asrani, MD, Duke Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04639947
Other Study ID Numbers:
  • Pro00106897
First Posted:
Nov 23, 2020
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension

Study Results

No Results Posted as of Nov 17, 2021