An interventional study of Icare rebound tonometry and Tonopen applanation in Intraocular Pressure, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-23.
Sponsored by Duke University · Not applicable, Interventional, and Diagnostic
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).
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
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.
Device: Icare rebound tonometry · Device: Tonopen applanation · Device: Goldmann applanation
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.
Device: Icare rebound tonometry · Device: Tonopen applanation · Device: Goldmann applanation
Also known as: Tonopen Avia
Measurement of Intraocular Pressure
The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.
Time frame: postoperative day #1
Adverse Events
The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure.
Time frame: postoperative day #1
| Milestone | Sequence 1: Icare Then Goldmann Then Tonopen | Sequence 2: Icare Then Tonopen Then Goldmann |
|---|---|---|
| Started | 34 | 34 |
| Completed | 34 | 34 |
| Not completed | 0 | 0 |
The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.
| mm Hg | Icare | Tonopen | Goldmann |
|---|---|---|---|
| Measurement of Intraocular Pressure | 15.9 ± 8.9 | 16.0 ± 7.3 | 16.9 ± 7.2 |
The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure.
| adverse events | Icare | Tonopen | Goldmann |
|---|---|---|---|
| Adverse Events | 0 | 0 | 0 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sequence 1: Icare, Goldmann, Tonopen | — | 0/34 (0%) | 0/34 (0%) |
| Sequence 2: Icare, Tonopen, Goldmann | — | 0/34 (0%) | 0/34 (0%) |
| Age, Continuous(years) | Icare, Goldmann, Tonopen |
|---|---|
| Mean | 63 ± 13 |
| Sex: Female, Male(Participants) | Icare, Goldmann, Tonopen |
|---|---|
| Female | 33 |
| Male | 35 |
| Region of Enrollment(participants) | Icare, Goldmann, Tonopen |
|---|---|
| United States | 68 |
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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