GlaucomaEyeCheckNCT04639947
Reliability and Reproducibility of the Eye Check Tonometer
A study testing EyeCheck and Traditional Tonometer (Goldmann and Tonopen) in people with Glaucoma and Glaucoma, Suspect, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Glaucoma, Suspect
- What is being tested?
- EyeCheck and Traditional Tonometer (Goldmann and Tonopen)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2021to 2 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older,
- Any glaucoma patient or glaucoma suspect patient
- Presents for an appointment wearing their own soft contact lens.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- EyeCheck, Traditional Tonometer (Goldmann and Tonopen)
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeCheckDevice
EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes.
Traditional Tonometer (Goldmann and Tonopen)Device
Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.
| Study group | Role | What they receive |
|---|---|---|
| EyeCheck | Experimental | EyeCheck pressures will be measured with contact lens in place Receives: 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). Receives: Device: Traditional Tonometer (Goldmann and Tonopen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP) Measurements
Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start6 Jan 2021
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Why it stopped: Terminated due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Asrani, MD, Principal investigator, Duke Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639947
- Sponsor's protocol ID
- Pro00106897
- Acronym
- EyeCheck
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2020
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Currently, there is no plan to share data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04639947
- Acronym / sponsor ID
- EyeCheck / Pro00106897
- Conditions
- Glaucoma, Glaucoma, Suspect
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low accrual
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| EyeCheck | Experimental | Device: EyeCheckEyeCheck pressures will be measured with contact lens in place |
| Traditional Tonometer (Goldmann and Tonopen) | Active comparator | Device: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 years or older,
- Any glaucoma patient or glaucoma suspect patient
- Presents for an appointment wearing their own soft contact lens.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EyeCheckEyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes. | Device | EyeCheck |
| Traditional Tonometer (Goldmann and Tonopen)Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck. | Device | Traditional Tonometer (Goldmann and Tonopen) |
Primary outcome
Intraocular Pressure (IOP) Measurements
Time frame: Baseline
Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Currently, there is no plan to share data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Asrani, MD principal investigator
Duke Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EyeCheck and Traditional Tonometer (Goldmann and Tonopen) in people with Glaucoma and Glaucoma, Suspect, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (IOP) Measurements (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.