Intraocular PressureNCT01786954
iCare vs Tonopen vs Goldmann Applanation Post-vitrectomy Surgery
A study testing Icare rebound tonometry, Tonopen applanation and Goldmann applanation in people with Intraocular Pressure, run by Duke University at 1 site in United States.
Trial summary
The purpose of the study is to compare the measurement of pressure inside the eye using three different FDA-approved devices (Icare, Tonopen, and Goldmann applanation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Icare rebound tonometry, Tonopen applanation and Goldmann applanation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duke Eye Center patients 18 years or older
- capacity to give legally effective consent
- scheduled to undergo vitreoretinal surgery
Who cannot join
- individuals unable to give consent
- minors
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Eye Center
Durham, North Carolina, 27710
About this study
Official title: A Comparative Study of Icare Rebound Tonometry With Other Tonometry Modalities in Patients Following Vitreoretinal Surgery.
The purpose of the study is to compare the measurement of pressure inside the eye using three different FDA-approved devices (Icare, Tonopen, and Goldmann applanation).
Read the detailed description
The three above devices will be used to measure intraocular pressure in patients one day following vitreoretinal surgery. The underlying reason for surgery is not being considered in this study. The measured pressures will be compared across devices in eyes filled with fluid, gas, and silicone oil.
- Conditions
- Intraocular Pressure
- Being tested
- Icare rebound tonometry, Tonopen applanation, Goldmann applanation
- Keywords
- vitreoretinal surgery, intraocular pressure, applanation, rebound, tonometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icare rebound tonometryDevice
Tonopen applanationDevice
Also called Tonopen Avia
Goldmann applanationDevice
| Study group | Role | What they receive |
|---|---|---|
| Icare then Goldmann then Tonopen | Experimental | Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation. Patients receive Icare first and then are randomized to receive Tonopen followed by Goldmann OR Goldmann followed by Tonopen. This arm is Icare then Goldmann then Tonopen. Receives: Device: Icare rebound tonometry; Device: Tonopen applanation; Device: Goldmann applanation |
| Icare then Tonopen then Goldmann | Experimental | Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation. Patients receive Icare first and then are randomized to receive Tonopen followed by Goldmann OR Goldmann followed by Tonopen. This arm is Icare then Tonopen then Goldmann. Receives: Device: Icare rebound tonometry; Device: Tonopen applanation; Device: Goldmann applanation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Intraocular Pressure
The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.
Measured: postoperative day #1
Secondary outcomes (1)
Adverse Events
The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure.
Measured: postoperative day #1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Hahn, MD, PhD, Principal investigator, Duke University Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786954
- Sponsor's protocol ID
- Pro00036498
- Status last verified
- Jan 2016
- First submitted
- 6 Feb 2013
- Last updated
- 23 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Icare Rebound Tonometry With Other Tonometry Modalities in Patients Following Vitreoretinal Surgery.
- ClinicalTrials.gov ID
- NCT01786954
- Acronym / sponsor ID
- Pro00036498
- Conditions
- Intraocular Pressure
- Keywords
- vitreoretinal surgery, intraocular pressure, applanation, rebound, tonometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Posted 22 Feb 2016
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 the study is to compare the measurement of pressure inside the eye using three different FDA-approved devices (Icare, Tonopen, and Goldmann applanation).
Detailed description
The three above devices will be used to measure intraocular pressure in patients one day following vitreoretinal surgery. The underlying reason for surgery is not being considered in this study. The measured pressures will be compared across devices in eyes filled with fluid, gas, and silicone oil.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icare then Goldmann then Tonopen | Experimental | Device: Icare rebound tonometry, Device: Tonopen applanation, Device: Goldmann applanationEnrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation. Patients receive Icare first and then are randomized to receive Tonopen followed by Goldmann OR Goldmann followed by Tonopen. This arm is Icare then Goldmann then Tonopen. |
| Icare then Tonopen then Goldmann | Experimental | Device: Icare rebound tonometry, Device: Tonopen applanation, Device: Goldmann applanationEnrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation. Patients receive Icare first and then are randomized to receive Tonopen followed by Goldmann OR Goldmann followed by Tonopen. This arm is Icare then Tonopen then Goldmann. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Duke Eye Center patients 18 years or older
- capacity to give legally effective consent
- scheduled to undergo vitreoretinal surgery
Key exclusion criteria (2 listed)
- individuals unable to give consent
- minors
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 |
|---|---|---|
| Icare rebound tonometry | Device | Icare then Goldmann then Tonopen, Icare then Tonopen then Goldmann |
| Tonopen applanationAlso: Tonopen Avia | Device | Icare then Goldmann then Tonopen, Icare then Tonopen then Goldmann |
| Goldmann applanation | Device | Icare then Goldmann then Tonopen, Icare then Tonopen then Goldmann |
Primary outcome
Measurement of Intraocular Pressure
Time frame: postoperative day #1
The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.
1 secondary outcome
Adverse Events
Time frame: postoperative day #1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul Hahn, MD, PhD principal investigator
Duke University Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Icare rebound tonometry, Tonopen applanation and Goldmann applanation in people with Intraocular Pressure, run by Duke University 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 3 inclusion and 2 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 23 May 2016. 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?
Yes. Results are posted in the registry (first posted 22 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement of Intraocular Pressure (time frame: postoperative day #1). 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 23 May 2016.