KeratoconusNCT04180111
Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism
An observational study of Keratoconus, run by Intuor Technologies, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. Read more about this study
- Who is it for?
- Ages 18 to 101 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- CATS Tonometer
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2019to 30 Dec 2019
- Phase
- Observational
- 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 to 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Twenty three (23) Subjects 18 years and older and will be enrolled from one clinical. Subjects will be chosen from patients who are being examined for a corneal cross-linking procedure.
Who may be able to join
- Male and female patients, at least 18 years of age
- Subject has a clear understanding and agrees to all the conditions of the informed consent form
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
- Those who have had corneal surgery including corneal laser surgery
- Microphthalmos
- Buphthalmos
Show all 10Show fewer
- Severe Dry eyes
- Lid squeezers - blepharospasm
- Nystagmus
- corneal or conjunctival infection.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Arizona Eye Consultants
Tucson, Arizona, 85710
Sean McCafferty, MD, 520-400-4255, sjmccafferty66@hotmail.com
About this study
The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.
Read the detailed description
This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative sites in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.
- Conditions
- Keratoconus
- Being tested
- CATS Tonometer
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATS TonometerDevice
CATS Tonometer Prism
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP measurement
comparative IOP measurement between CATS and GAT tonometer prisms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start5 May 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuor Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180111
- Sponsor's protocol ID
- CATS crosslink
- Status last verified
- Nov 2019
- First submitted
- 23 Nov 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism
- ClinicalTrials.gov ID
- NCT04180111
- Acronym / sponsor ID
- CATS crosslink
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Intuor Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 May 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 27 Nov 2019 (actual)
- 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.
The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.
Detailed description
This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative sites in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty three (23) Subjects 18 years and older and will be enrolled from one clinical. Subjects will be chosen from patients who are being examined for a corneal cross-linking procedure.
Key inclusion criteria (2 listed)
- Male and female patients, at least 18 years of age
- Subject has a clear understanding and agrees to all the conditions of the informed consent form
Key exclusion criteria (10 listed)
- • Subject has undergone ocular surgery within the last 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 |
|---|---|---|
| CATS TonometerCATS Tonometer Prism | Device | – |
Primary outcome
IOP measurement
Time frame: 6 months
comparative IOP measurement between CATS and GAT tonometer prisms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, 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 10 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: status not confirmed, as of the sponsor's last update on 27 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP measurement (time frame: 6 months). 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 27 Nov 2019.