Intraocular PressureNCT02837536
Horizontal vs. Vertical Positioning of the iCare Rebound Tonometer and Effects on Intraocular Pressure Readings
A study testing Horizontal iCare and Vertical iCare in people with Intraocular Pressure, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The goal of this study is to evaluate the agreement between intraocular pressure (IOP) measurements taken by iCare, held in both vertical and horizontal positions. In addition, iCare measurements will be compared against pneumotonometry measurements to assess for accuracy. 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
- What is being tested?
- Horizontal iCare and Vertical iCare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2016to 23 Dec 2016
- 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
- 18 years of age or older
- Must be able to understand and sign and informed consent form that has been approved by an Institutional Review Board/Ethics Committee
Who cannot join
- Evidence of corneal epithelial defects or pathology affecting corneal rigidity
- Use of topical ophthalmic medications (except for artificial tears)
- History or corneal surgeries
- Any condition that would prevent or inhibit intraocular pressure measurements using iCare or pneumotonometry
- Evidence of ocular infection 30 days prior to enrollment
- Allergy to proparacaine or latex
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to evaluate the agreement between intraocular pressure (IOP) measurements taken by iCare, held in both vertical and horizontal positions. In addition, iCare measurements will be compared against pneumotonometry measurements to assess for accuracy.
- Conditions
- Intraocular Pressure
- Being tested
- Horizontal iCare, Vertical iCare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizontal iCareOther
IOP of the right eye will be measured using the iCare tonometer held in the horizontal position first and then in the vertical position.
Vertical iCareOther
IOP of the right eye will be measured using the iCare tonometer held in the vertical position first and then in the horizontal position.
| Study group | Role | What they receive |
|---|---|---|
| Horizontal iCare | Active comparator | In the horizontal iCare arm, these patients were randomized to have their IOP measured with the iCare tonometer held in the horizontal position first and then their IOP measured with the iCare tonometer held in the vertical position. Receives: Other: Horizontal iCare; Other: Vertical iCare |
| Vertical iCare | Active comparator | In the vertical iCare arm, these patients were randomized to have their IOP measured with the iCare tonometer held in the vertical position first and then their IOP measured with the iCare tonometer held in the horizontal position. Receives: Other: Horizontal iCare; Other: Vertical iCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP taken by iCare - horizontal
Measured: 1 Day
IOP taken by iCare - vertical
Measured: 1 Day
IOP taken by pneumatonometer
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start23 Jun 2016
- Primary completion20 Jul 2016
- Study completion23 Dec 2016
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.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Cizik Eye Clinic
- Responsible party
- Principal investigator, Robert Feldman, The University of Texas Health Science Center, Houston
- Investigators
- Robert M. Feldman, M.D., Principal investigator, Robert Cizik Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837536
- Sponsor's protocol ID
- HSC-MS-16-0396
- Status last verified
- Mar 2017
- First submitted
- 8 Jul 2016
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Horizontal vs. Vertical Positioning of the iCare Rebound Tonometer and Effects on Intraocular Pressure Readings
- ClinicalTrials.gov ID
- NCT02837536
- Acronym / sponsor ID
- HSC-MS-16-0396
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Robert Cizik Eye Clinic
- Study start
- 23 Jun 2016 (actual)
- Primary completion
- 20 Jul 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 19 Jul 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.
The goal of this study is to evaluate the agreement between intraocular pressure (IOP) measurements taken by iCare, held in both vertical and horizontal positions. In addition, iCare measurements will be compared against pneumotonometry measurements to assess for accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Horizontal iCare | Active comparator | Other: Horizontal iCare, Other: Vertical iCareIn the horizontal iCare arm, these patients were randomized to have their IOP measured with the iCare tonometer held in the horizontal position first and then their IOP measured with the iCare tonometer held in the vertical position. |
| Vertical iCare | Active comparator | Other: Horizontal iCare, Other: Vertical iCareIn the vertical iCare arm, these patients were randomized to have their IOP measured with the iCare tonometer held in the vertical position first and then their IOP measured with the iCare tonometer held in the horizontal position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Must be able to understand and sign and informed consent form that has been approved by an Institutional Review Board/Ethics Committee
Key exclusion criteria (6 listed)
- Evidence of corneal epithelial defects or pathology affecting corneal rigidity
- Use of topical ophthalmic medications (except for artificial tears)
- History or corneal surgeries
- Any condition that would prevent or inhibit intraocular pressure measurements using iCare or pneumotonometry
- Evidence of ocular infection 30 days prior to enrollment
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 |
|---|---|---|
| Horizontal iCareIOP of the right eye will be measured using the iCare tonometer held in the horizontal position first and then in the vertical position. | Other | Horizontal iCare, Vertical iCare |
| Vertical iCareIOP of the right eye will be measured using the iCare tonometer held in the vertical position first and then in the horizontal position. | Other | Horizontal iCare, Vertical iCare |
Primary outcome
IOP taken by iCare - horizontal
Time frame: 1 Day
IOP taken by iCare - vertical
Time frame: 1 Day
IOP taken by pneumatonometer
Time frame: 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 Mar 2017.
- 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.
Robert M. Feldman, M.D. principal investigator
Robert Cizik Eye Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horizontal iCare and Vertical iCare in people with Intraocular Pressure, run by The University of Texas Health Science Center, Houston 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 6 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 Mar 2017. 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?
IOP taken by iCare - horizontal (time frame: 1 Day). The study lists 3 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 Mar 2017.