Intraocular PressureNCT02138279
Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements
An observational study of Intraocular Pressure and Corneal Pachymetry, run by Topcon Medical Systems, Inc. at 1 site in United States.
Trial summary
The primary objective of this clinical study is to collect clinical data to support FDA 510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The secondary objective is to evaluate any adverse events found during the clinical study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure, Corneal Pachymetry
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ophthalmology practice
Who may be able to join
- At least 18 years of age of either sex and any race or ethnicity;
- Willing and able to provide written informed consent prior to any study procedures being performed;
- Willing and able to follow all instructions and attend all study visits;
- Best Spectacle Corrected Visual Acuity (BSCVA) of 0.3 logMAR (20/40 Snellen equivalent) or better in both eyes as measured using an ETDRS chart.
Who cannot join
- Only one functional eye;
- Poor or eccentric fixation;
- Corneal scarring or have had corneal surgery, including corneal laser surgery;
- Microphthalmos;
- Buphthalmos;
- Contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
Show all 12Show fewer
- Dry eyes, meaning having been diagnoses by a physician with dry eyes and currently using a prescribed medication;
- Lid squeezer - blepharospasm;
- Nystagmus;
- Keratoconus;
- Any other corneal or conjunctival pathology or infection;
- Condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: Comparative Study of the Topcon Tonometers - CT-800, CT-1, CT-1P and TRK-2P to Demonstrate Conformance to ANSI Z80.10-2009 Ophthalmic Instruments -Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for CT-1P and TRK-2P With the Konan CellChek Plus (Predicate)
The primary objective of this clinical study is to collect clinical data to support FDA 510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The secondary objective is to evaluate any adverse events found during the clinical study.
- Conditions
- Intraocular Pressure, Corneal Pachymetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Male and female adults 18+ years of age | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of intraocular pressure measurements from predicate vs. investigational device
Measured: Single timepoint - 1 day
Agreement of central corneal thickness measurements from predicate vs. investigational device
Measured: Single time point - 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138279
- Sponsor's protocol ID
- TOPCON-TON-US-0001
- Status last verified
- Jun 2022
- First submitted
- 23 Apr 2014
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Topcon Tonometers - CT-800, CT-1, CT-1P and TRK-2P to Demonstrate Conformance to ANSI Z80.10-2009 Ophthalmic Instruments -Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for CT-1P and TRK-2P With the Konan CellChek Plus (Predicate)
- ClinicalTrials.gov ID
- NCT02138279
- Acronym / sponsor ID
- TOPCON-TON-US-0001
- Conditions
- Intraocular Pressure, Corneal Pachymetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 May 2014 (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.
The primary objective of this clinical study is to collect clinical data to support FDA 510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The secondary objective is to evaluate any adverse events found during the clinical study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male and female adults 18+ years of age | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ophthalmology practice
Key inclusion criteria (4 listed)
- At least 18 years of age of either sex and any race or ethnicity;
- Willing and able to provide written informed consent prior to any study procedures being performed;
- Willing and able to follow all instructions and attend all study visits;
- Best Spectacle Corrected Visual Acuity (BSCVA) of 0.3 logMAR (20/40 Snellen equivalent) or better in both eyes as measured using an ETDRS chart.
Key exclusion criteria (12 listed)
- Only one functional eye;
- Poor or eccentric fixation;
- Corneal scarring or have had corneal surgery, including corneal laser surgery;
- Microphthalmos;
- Buphthalmos;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement of intraocular pressure measurements from predicate vs. investigational device
Time frame: Single timepoint - 1 day
Agreement of central corneal thickness measurements from predicate vs. investigational device
Time frame: Single time point - 1 day
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 Jun 2022.
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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?
An observational study of Intraocular Pressure and Corneal Pachymetry, run by Topcon Medical Systems, 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 4 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 8 Jun 2022. 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?
Agreement of intraocular pressure measurements from predicate vs. investigational device (time frame: Single timepoint - 1 day). The study lists 2 primary outcomes in all. 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 8 Jun 2022.