GlaucomaNCT06266351
EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS
An observational study of Glaucoma and Ocular Hypertension, run by Intuor Technologies, Inc. at 2 sites in United States.
Trial summary
The CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Ocular Hypertension, Normal Tension Glaucoma
- What is being tested?
- This is observational IOP measurement
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2024to 1 Aug 2024
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial: * At least 22 years of age and undergone LASIK treatment * Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form
Who may be able to join
- Subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial:
- At least 22 years of age and undergone LASIK treatment
- Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form
Who cannot join
- Subjects will be excluded from participation if they meet the following criteria:
- Subject has undergone ocular surgery within the last 3 months or LASIK within 6 months
- Pregnant or nursing women
- Those who have had previous corneal surgery excluding LASIK
- Keratoconus
- Corneal scarring
Show all 12Show fewer
- Microphthalmos
- Buphthalmos
- Dry eyes with clinical epithelial breakdown upon exam
- Lid squeezers - blepharospasm
- Nystagmus
- Corneal or conjunctival infection.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eye Specialty Group
Memphis, Tennessee, 38120
Arizona Eye Consultants
Tucson, Arizona, 85710
About this study
The CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral pressure in cadaver eyes.
- Conditions
- Glaucoma, Ocular Hypertension, Normal Tension Glaucoma
- Being tested
- This is observational IOP measurement
- Medical subject headings
- Glaucoma, Ocular Hypertension, Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is observational IOP measurementDevice
IOP measurement of patients having LASIK with both CATS and GAT
| Study group | Role | What they receive |
|---|---|---|
| IOP measurement with CATS | Not described Receives: Device: This is observational IOP measurement | |
| IOP measurement with GAT | Not described Receives: Device: This is observational IOP measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP measurement difference between CATS and GAT in LASIK patients
IOP measurement
Measured: single measurement 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start12 Feb 2024
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 198 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
- NCT06266351
- Sponsor's protocol ID
- LASIKIOP
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: likely will provide deindentified data
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS
- ClinicalTrials.gov ID
- NCT06266351
- Acronym / sponsor ID
- LASIKIOP
- Conditions
- Glaucoma, Ocular Hypertension, Normal Tension Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Intuor Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 20 Feb 2024 (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 CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral pressure in cadaver eyes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOP measurement with CATS | – | Device: This is observational IOP measurement |
| IOP measurement with GAT | – | Device: This is observational IOP measurement |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial: * At least 22 years of age and undergone LASIK treatment * Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form
Key inclusion criteria (3 listed)
- Subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial:
- At least 22 years of age and undergone LASIK treatment
- Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form
Key exclusion criteria (12 listed)
- Subjects will be excluded from participation if they meet the following criteria:
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 |
|---|---|---|
| This is observational IOP measurementIOP measurement of patients having LASIK with both CATS and GAT | Device | IOP measurement with CATS, IOP measurement with GAT |
Primary outcome
IOP measurement difference between CATS and GAT in LASIK patients
Time frame: single measurement 1 day
IOP measurement
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 5 Nov 2024.
- Individual participant dataSharing planned: Undecided. likely will provide deindentified data
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Ocular Hypertension, run by Intuor Technologies, Inc. at 2 sites 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 12 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 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
IOP measurement difference between CATS and GAT in LASIK patients (time frame: single measurement 1 day). 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 Nov 2024.