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The purpose of this study is to investigate the anterior and posterior structure and functional changes and vascular alterations when performing phacoemulsification at high IOP vs low, more physiological IOP using Centurion® Vision System with Active Sentry® handpiece. These devices are approved by the US Food and Drug Administration (FDA).
To investigate the anterior and posterior physiological changes when performing phacoemulsification at high IOP vs low, more physiologic IOP using Centurion® Vision System with Active Sentry® handpiece
Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye
Operating at lower, more physiological IOP using Active Sentry® handpiece during cataract surgery will use less BSS fluid usage. (Lower IOP settings are also expected to result in less subclinical changes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High IOP | Eyes in this arm will maintain an IOP of 65mmHg throughout the cataract surgery. |
| |
| Low IOP | Eyes in this arm will maintain an IOP of 28mmHg throughout the cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High IOP | Other | Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated fluid usage- High IOP Group | Measurement of fluid usage (ml). | Intraoperative |
| Estimated fluid usage- Low IOP Group | Measurement of fluid usage (ml). | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Macular Thickness | Macular thickness measured in microns at week 1, month 1, and month 3. Measured by optical coherence tomography (OCT). | post procedure at 1 week, 1 month, and 3 months |
| Corneal Thickness |
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Inclusion Criteria:
Exclusion Criteria:
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25 cataract surgery patients form ophthalmology clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Rauen, MD | Wolfe Eye Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29074989 | Result | Tang Y, Chen X, Zhang X, Tang Q, Liu S, Yao K. Clinical evaluation of corneal changes after phacoemulsification in diabetic and non-diabetic cataract patients, a systematic review and meta-analysis. Sci Rep. 2017 Oct 26;7(1):14128. doi: 10.1038/s41598-017-14656-7. | |
| 33199984 | Result | Li T, Guadie A, Feng L, Fan J, Jiang Z, Liu F. Influence of cataract surgery on macular vascular density in patients with myopia using optical coherence tomography angiography. Exp Ther Med. 2020 Dec;20(6):258. doi: 10.3892/etm.2020.9388. Epub 2020 Oct 27. |
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|
| Low IOP | Other | Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye |
|
Corneal thickness measured in microns at 1 day, week 1, month 1, and month 3. Measured by pentacam tomography.
| post procedure at 1 day, 1 week, 1 month, and 3 months |
| 30607294 | Result | Zeng S, Liang C, He Y, Chen Y, Zhao Q, Dai S, Cheng F, Zhang J, Jiang X. Changes of Subfoveal Choroidal Thickness after Cataract Surgery: A Meta-Analysis. J Ophthalmol. 2018 Nov 12;2018:2501325. doi: 10.1155/2018/2501325. eCollection 2018. |
| 25325894 | Result | Vasavada V, Raj SM, Praveen MR, Vasavada AR, Henderson BA, Asnani PK. Real-time dynamic intraocular pressure fluctuations during microcoaxial phacoemulsification using different aspiration flow rates and their impact on early postoperative outcomes: a randomized clinical trial. J Refract Surg. 2014 Aug;30(8):534-40. doi: 10.3928/1081597X-20140711-06. |
| 23275902 | Result | Chen D, Zhu J, Li J, Ding XX, Lu F, Zhao YE. Effect of simulated dynamic intraocular pressure on retinal thickness measured by optical coherence tomography after cataract surgery. Int J Ophthalmol. 2012;5(6):687-93. doi: 10.3980/j.issn.2222-3959.2012.06.07. Epub 2012 Dec 18. |
| 35416902 | Result | Liu X, Fang Y, Zhou Y, Wang M, Luo Y. Dynamic changes in retinal vessel density observed by optical coherence tomography angiography after phacoemulsification: active vs gravity fluidics system. Arq Bras Oftalmol. 2022 Apr 8;85(2):205-207. doi: 10.5935/0004-2749.20220093. eCollection 2022. No abstract available. |