- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02990169
Clinical Evaluation of CATS Tonometer Prism
October 19, 2018 updated by: Intuor Technologies, Inc.
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).
Seventy-five (75) Subjects 18 and older and will be enrolled.
Subjects will be screened based on standard of care vision examination at the clinical investigation sites.
All subjects will undergo a standard ophthalmic exam and informed consent.
IOP will be measured using a Goldmann tonometer armature with both the standard flat GAT prism and the modified curved CATS prism alternately inserted.
The only additional measurement is central corneal thickness (CCT) which is used to correct for one of the corneal biomechanical errors seen in the GAT prism and is currently standard of care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85710
- Arizona Eye Consultants
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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 between 0.600 mm and 0.500 mm (more than 2 standard deviations about the human mean)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Goldmann Tonometer
determine if the CATS tonometer prism effectively reduces sensitivity to IOP errors produced by corneal thickness and therefore provides a more accurate IOP reading compared to the reference tonometer (Goldmann prism), based upon the correction value table for Goldmann tonometer prism
|
IOP tonometer prism for assessment of intraocular pressure
|
ACTIVE_COMPARATOR: CATS tonometer
determine if the CATS tonometer prism effectively reduces sensitivity to IOP errors produced by corneal thickness and therefore provides a more accurate IOP reading compared to the reference tonometer (Goldmann prism), based upon the correction value table for Goldmann tonometer prism
|
IOP tonometer prism for assessment of intraocular pressure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings.
Time Frame: From date of randomization until 24 hours
|
From date of randomization until 24 hours
|
All subjects will have corneal thickness measurements performed and the CATS tonometer prism intraocular pressure readings will be compared to Goldmann tonometer readings using a correction value table.
Time Frame: From date of randomization until 24 hours
|
From date of randomization until 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ACTUAL)
October 1, 2018
Study Completion (ACTUAL)
October 1, 2018
Study Registration Dates
First Submitted
November 28, 2016
First Submitted That Met QC Criteria
December 8, 2016
First Posted (ESTIMATE)
December 13, 2016
Study Record Updates
Last Update Posted (ACTUAL)
October 22, 2018
Last Update Submitted That Met QC Criteria
October 19, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CATS and Corneal Thickness
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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