| Literature DB >> 32078144 |
Tanner J Ferguson1, Catherine G Knier2, Uttio Roy Chowdhury2, Kjerseten J Monson2, Michael Greenwood3, Russell J Swan3, Richard Gorham4, John P Berdahl3, Michael P Fautsch2.
Abstract
PURPOSE: To investigate the precision and accuracy of IOP measurements using a pneumatonometer and a tonometer tip cover (Tono-Pen® tip cover) acting as a membrane between a cadaver eye model and pneumatonometer probe.Entities:
Keywords: Diagnostics; Intraocular pressure; Open-angle glaucoma; Ophthalmic techniques; Tonometry
Year: 2020 PMID: 32078144 PMCID: PMC7054586 DOI: 10.1007/s40123-020-00235-z
Source DB: PubMed Journal: Ophthalmol Ther
Fig. 1Picture showing how the pneumatonometer is inserted through the access port on the Excursion MPD, a modified version of the Multi-pressure Dial that facilitates IOP measurement during wear via pneumatonometry across a Tono-Pen tip cover acting as a membrane
Fig. 2Standard iteration of the Multi-Pressure Dial, a novel device capable of non-invasively lowering intraocular pressure
Description of the test protocol for IOP measurements and delineation of the roles of the operator and the reader during the protocol
| Procedure | Performed by operator | Performed by reader |
|---|---|---|
| Randomize IOP test setting to 7, 10, 20, 30 mmHg with DMEM column preparation | X | |
| Randomized to with or without Tono-Pen cover; if | X | |
| Record the pressure reading from the pressure transducer | X | |
| Advance the pneumatonometer probe onto the cornea to obtain measurementa | X | |
| Record IOP measurement from Model 30a | X | |
| Allow the eye pressure level to settle to ± 1 mmHg of original IOP before each subsequent measurementa | X |
aThese steps will be repeated nine times for a total of ten measurements at each procedure setting
Summary and comparison of the IOP measurements at each pressure setting with and without the Tono-Pen cover
| Pressure setting configuration | With Tono-Pen cover | Without Tono-Pen cover | Difference (with − without) Mean ± SD | 95% CI for mean difference |
|---|---|---|---|---|
| Configuration #1 ( | 8.18 ± 0.75 | 10.11 ± 1.39 | − 1.94 ± 0.98 | − 2.25, − 1.63 |
| Configuration #2 ( | 9.24 ± 1.05 | 10.76 ± 0.76 | − 1.53 ± 1.05 | − 1.86, − 1.19 |
| Configuration #3 ( | 9.24 ± 0.78 | 10.84 ± 1.17 | − 1.60 ± 1.66 | − 2.13, − 1.07 |
| Overall ( | 8.88 ± 1.00 | 10.57 ± 1.17 | − 1.69 ± 1.27 | − 1.92, − 1.46 |
| Configuration #1 ( | 10.83 ± 1.92 | 12.34 ± 1.50 | − 1.51 ± 1.34 | − 1.94, − 1.08 |
| Configuration #2 ( | 11.53 ± 1.59 | 12.94 ± 1.02 | − 1.41 ± 1.19 | − 1.79, − 1.03 |
| Configuration #3 ( | 10.89 ± 1.37 | 12.59 ± 1.27 | − 1.70 ± 1.31 | − 2.12, − 1.28 |
| Overall ( | 11.08 ± 1.66 | 12.62 ± 1.29 | − 1.54 ± 1.28 | − 1.77, − 1.31 |
| Configuration #1 ( | 19.69 ± 0.72 | 20.61 ± 0.79 | − 0.93 ± 0.82 | − 1.19, − 0.66 |
| Configuration #2 ( | 19.86 ± 0.59 | 20.56 ± 1.01 | − 0.70 ± 1.11 | − 1.06, − 0.34 |
| Configuration #3 ( | 20.99 ± 0.86 | 21.91 ± 1.25 | − 0.93 ± 0.76 | − 1.17, − 0.68 |
| Overall ( | 20.18 ± 0.93 | 21.03 ± 1.20 | − 0.85 ± 0.91 | − 1.01, − 0.69 |
| Configuration #1 ( | 27.85 ± 1.00 | 28.53 ± 1.59 | − 0.68 ± 1.12 | − 1.03, − 0.32 |
| Configuration #2 ( | 28.58 ± 0.96 | 29.41 ± 2.28 | − 0.84 ± 1.74 | − 1.40, − 0.28 |
| Configuration #3 ( | 28.29 ± 0.64 | 28.71 ± 0.94 | − 0.43 ± 0.95 | − 0.73, − 0.12 |
| Overall ( | 28.24 ± 0.92 | 28.88 ± 1.72 | − 0.65 ± 1.32 | − 0.88, − 0.41 |
N number of measurements
95% CI (confidence interval) for mean difference based on t distribution
Fig. 3Bland-Altman plot developed based on the difference between measurements with and without the Tono-Pen cover and the mean of the measurements occurring with and without the Tono-Pen cover. Jitter was used for multiple observations
Summary of the IOP measurements with the Tono-Pen cover in place
| Pressure | Statistics | Configuration | |||
|---|---|---|---|---|---|
| Setting | #1 | #2 | #3 | Overall | |
| 7 mmHg | No. of eyes | 4 | 4 | 4 | 4 |
| 40 | 40 | 40 | 120 | ||
| Mean ± SD | 8.2 ± 0.8 | 9.2 ± 1.1 | 9.2 ± 0.8 | 8.9 ± 1.0 | |
| 95% CI | 7.9, 8.4 | 8.9, 9.6 | 8.9, 9.5 | 8.7, 9.1 | |
| %CV | 9.1% | 11.4% | 8.4% | 11.2% | |
| 10 mmHg | No. of eyes | 4 | 4 | 4 | 4 |
| 40 | 40 | 40 | 120 | ||
| Mean ± SD | 10.8 ± 1.9 | 11.5 ± 1.6 | 10.9 ± 1.4 | 11.1 ± 1.7 | |
| 95% CI | 10.2, 11.4 | 11.0, 12.0 | 10.5, 11.3 | 10.8, 11.4 | |
| %CV | 17.7% | 13.8% | 12.5% | 14.9% | |
| 20 mmHg | No. of eyes | 4 | 4 | 4 | 4 |
| 40 | 40 | 40 | 120 | ||
| Mean ± SD | 19.7 ± 0.7 | 19.9 ± 0.6 | 21.0 ± 0.9 | 20.2 ± 0.9 | |
| 95% CI | 19.5, 19.9 | 19.7, 20.1 | 20.7, 21.3 | 20.0, 20.4 | |
| %CV | 3.7% | 2.9% | 4.1% | 4.6% | |
| 30 mmHg | No. of eyes | 4 | 4 | 4 | 4 |
| 40 | 40 | 40 | 120 | ||
| Mean ± SD | 27.9 ± 1.0 | 28.6 ± 1.0 | 28.3 ± 0.6 | 28.2 ± 0.9 | |
| 95% CI | 27.5, 28.2 | 28.3, 28.9 | 28.1, 28.5 | 28.1, 28.4 | |
| %CV | 3.6% | 3.4% | 2.3% | 3.3% | |
Min minimum, Max minimum, CV coefficient of variation, SD standard deviation, CI confidence interval
Repeatability and reproducibility statistical values as well as the intraclass correlation coefficient (ICC) values for each pressure setting with and without the Tono-Pen cover in place
| Mean | Repeatability | Reproducibility | ICC | |||||
|---|---|---|---|---|---|---|---|---|
| SD | Limit | %CV | SD | Limit | %CV | |||
| With Tono-Pen cover | ||||||||
| 7 mmHg | 8.88 | 0.44 | 1.235 | 4.96 | 0.54 | 1.50 | 6.03 | 0.82 |
| 10 mmHg | 11.08 | 0.49 | 1.358 | 4.38 | 0.54 | 1.50 | 4.84 | 0.98 |
| 20 mmHg | 20.18 | 0.42 | 1.184 | 2.09 | 0.59 | 1.66 | 2.94 | 0.69 |
| 30 mmHg | 28.24 | 0.57 | 1.582 | 2.00 | 0.41 | 1.14 | 1.44 | 0.87 |
| Without Tono-Pen cover | ||||||||
| 7 mmHg | 10.57 | 0.47 | 1.324 | 4.48 | 0.61 | 1.71 | 5.76 | 0.94 |
| 10 mmHg | 12.62 | 0.43 | 1.210 | 3.42 | 0.85 | 2.38 | 6.74 | 0.94 |
| 20 mmHg | 21.03 | 0.57 | 1.588 | 2.70 | 0.88 | 2.45 | 4.16 | 0.78 |
| 30 mmHg | 28.88 | 0.68 | 1.907 | 2.36 | 1.79 | 5.01 | 6.19 | 0.91 |
SD standard deviation, %CV percent coefficient of variance, ICC intraclass correlation coefficient
| The excursion test method is a developed method of IOP measurement with pneumatonometry and a Tono-Pen cover gently touching the surface of the cornea. |
| This method of IOP measurement was developed to work in concert with the Excursion multi-pressure dial, a modified version of the multi-pressure dial. |
| The Excursion multi-pressure dial contains an access port within the lens of the goggles to allow pneumatonometry measurements while negative pressure is active without breaching the sealed environment. |
| The excursion test method is a reliable and precise form of IOP measurement. |