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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icare rebound tonometry | Device |
| ||
| Tonopen applanation |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Intraocular Pressure | The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery. | postoperative day #1 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure. | postoperative day #1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Hahn, MD, PhD | Duke University Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Eye Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Icare Then Goldmann Then Tonopen | Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Goldmann applanation then Tonopen applanation. Icare rebound tonometry Goldmann applanation Tonopen applanation |
| FG001 | Sequence 2: Icare Then Tonopen Then Goldmann | Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Tonopen applanation then Goldmann applanation. Icare rebound tonometry Tonopen applanation Goldmann applanation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Icare, Goldmann, Tonopen | Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation. Icare rebound tonometry Tonopen applanation Goldmann applanation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurement of Intraocular Pressure | The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery. | Of the 68 patients enrolled, only 50 patients who received IOP measurement one day following vitrectomy surgery were analyzed. Those with IOP measurement following non-vitrectomy surgery were subsequently excluded from the analysis. | Posted | Mean | Standard Deviation | mm Hg | postoperative day #1 |
|
1 day
All patients were examined with a complete ophthalmic exam following IOP measurements.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sequence 1: Icare, Goldmann, Tonopen | Sequence 1: Icare, then Goldmann, then Tonopen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Paul Hahn | Duke Eye Center | 919-684-5631 | paul.s.hahn@duke.edu |
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| Device |
|
|
| Goldmann applanation | Device |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
| OG002 | Goldmann | Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation. |
|
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| Secondary | Adverse Events | The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure. | Adverse events were analyzed for all enrolled patients, in contrast to IOP measurements, which were only analyzed for the 50 post-vitrectomy patients. | Posted | Number | adverse events | postoperative day #1 |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Sequence 2: Icare, Tonopen, Goldmann | Sequence 2: Icare, then Tonopen, then Goldmann | 0 | 34 | 0 | 34 |
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