Ocular HypertensionNCT02989909
Clinical Evaluation of CATS Tonometer Prism
A study testing CATS tonometer prism and Goldmann tonometer prism in people with Ocular Hypertension, run by Intuor Technologies, Inc. at 1 site in United States.
Trial summary
Prospective, open-labeled, randomized, controlled, multicenter study at two clinical investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Hypertension
- What is being tested?
- CATS tonometer prism and Goldmann tonometer prism
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent (and assent when applicable)obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Male and female patients, at least 18 years of age
Who cannot join
- Subject has undergone ocular surgery within the last 3 months
- Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
- Pregnant or nursing women
- Subjects with only one functional eye
- Those with one eye having poor or eccentric fixation
- Eyes displaying an oval contact image
Show all 16Show fewer
- Those with corneal scarring or who have had corneal surgery including corneal laser surgery
- Microphthalmos
- Buphthalmos
- Contact lens wearers
- Severe Dry eyes
- Lid squeezers - blepharospasm
- Nystagmus
- Keratoconus
- Any other corneal or conjunctival pathology or infection.
- Central corneal thickness greater than 0.600 mm or less than 0.500 mm (2 standard deviations about the human mean)
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, open-labeled, randomized, controlled, multicenter study at two clinical investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).
Of the 200 eyes, at least 10 highly astigmatic eyes (>3 D of corneal astigmatism) each in the low, medium and high IOP ranges shall have the same clinical testing and analysis of results, with the analysis kept separate from that of the main group.
- Conditions
- Ocular Hypertension
- Being tested
- CATS tonometer prism, Goldmann tonometer prism
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATS tonometer prismDevice
demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range
Goldmann tonometer prismDevice
demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range
| Study group | Role | What they receive |
|---|---|---|
| Goldmann Tonometer | Active comparator | Goldmann Tonometer prism will be used as a based line comparator for tolerance assessment versus the active test comparator CATS tonometer prism Receives: Device: Goldmann tonometer prism |
| CATS tonometer | Experimental | CATS tonometer prism being used as the test product to assess IOP measurement versus active comparator the Goldmann Tonometer prism Receives: Device: CATS tonometer prism |
What is being measured
The primary outcome is the main question the study is designed to answer.
All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings in establishing effectiveness.
Measured: From date of randomization until 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuor Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989909
- Sponsor's protocol ID
- CATS Tonometer, LLC - CP-01
- Status last verified
- Aug 2018
- First submitted
- 28 Nov 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McCafferty SJ, Tetrault K, McColgin A, Chue W, Levine J, Muller M. Modified Goldmann prism intraocular pressure measurement accuracy and correlation to corneal biomechanical metrics: multicentre randomised clinical trial. Br J Ophthalmol. 2019 Dec;103(12):1840-1844. doi: 10.1136/bjophthalmol-2018-313470. Epub 2019 Feb 22.
PubMed 30796054
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of CATS Tonometer Prism
- ClinicalTrials.gov ID
- NCT02989909
- Acronym / sponsor ID
- CATS Tonometer, LLC - CP-01
- Conditions
- Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Intuor Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, open-labeled, randomized, controlled, multicenter study at two clinical investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).
Of the 200 eyes, at least 10 highly astigmatic eyes (>3 D of corneal astigmatism) each in the low, medium and high IOP ranges shall have the same clinical testing and analysis of results, with the analysis kept separate from that of the main group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goldmann Tonometer | Active comparator | Device: Goldmann tonometer prismGoldmann Tonometer prism will be used as a based line comparator for tolerance assessment versus the active test comparator CATS tonometer prism |
| CATS tonometer | Experimental | Device: CATS tonometer prismCATS tonometer prism being used as the test product to assess IOP measurement versus active comparator the Goldmann Tonometer prism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent (and assent when applicable)obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Male and female patients, at least 18 years of age
Key exclusion criteria (16 listed)
- Subject has undergone ocular surgery within the last 3 months
- Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
- Pregnant or nursing women
- Subjects with only one functional eye
- Those with one eye having poor or eccentric fixation
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 |
|---|---|---|
| CATS tonometer prismdemonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range | Device | CATS tonometer |
| Goldmann tonometer prismdemonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range | Device | Goldmann Tonometer |
Primary outcome
All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings in establishing effectiveness.
Time frame: From date of randomization until 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Derived from this study: PubMed 30796054McCafferty SJ, Tetrault K, McColgin A, Chue W, Levine J, Muller M. Modified Goldmann prism intraocular pressure measurement accuracy and correlation to corneal biomechanical metrics: multicentre randomised clinical trial. Br J Ophthalmol. 2019 Dec;103(12):1840-1844. doi: 10.1136/bjophthalmol-2018-313470. Epub 2019 Feb 22.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CATS tonometer prism and Goldmann tonometer prism in people with Ocular Hypertension, run by Intuor Technologies, Inc. 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 2 inclusion and 16 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: finished, as of the sponsor's last update on 8 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings in establishing effectiveness. (time frame: From date of randomization until 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02989909, which also lists 1 linked publication.
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 8 Aug 2018.