Intraocular Pressure
Conditions
Keywords
vitreoretinal surgery, intraocular pressure, applanation, rebound, tonometry
Brief 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).
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.
Interventions
DEVICEIcare rebound tonometry
DEVICETonopen applanation
DEVICEGoldmann applanation
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Duke Eye Center patients 18 years or older * capacity to give legally effective consent * scheduled to undergo vitreoretinal surgery
Exclusion criteria
* individuals unable to give consent * minors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Intraocular Pressure | postoperative day #1 | The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | postoperative day #1 | The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 68 |
| Total | 68 |
Baseline characteristics
| Characteristic | Icare, Goldmann, Tonopen |
|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 68 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Icare | Measurement of Intraocular Pressure | 15.9 mm Hg | Standard Deviation 8.9 |
| Tonopen | Measurement of Intraocular Pressure | 16.0 mm Hg | Standard Deviation 7.3 |
| Goldmann | Measurement of Intraocular Pressure | 16.9 mm Hg | Standard Deviation 7.2 |
Secondary
Adverse Events
The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure.
Time frame: postoperative day #1
Population: Adverse events were analyzed for all enrolled patients, in contrast to IOP measurements, which were only analyzed for the 50 post-vitrectomy patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Icare | Adverse Events | 0 adverse events |
| Tonopen | Adverse Events | 0 adverse events |
| Goldmann | Adverse Events | 0 adverse events |