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The study will pertain to investigating the impact of high vs low IOP on the intraoperative experience and comfort for the patient and surgeon. Our hypothesis is that operating at a more physiological IOP using Unity VCS/CS and Centurion with Active Sentry at a higher, or more traditional IOP will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.
Objective/ Unmet Medical Need:
To investigate the impact of Unity VCS/CS with Intelligent Fluidics at a low IOP setting and Centurion with Active Sentry at a traditionally high IOP setting on the intraoperative experience for the patient and surgeon. Limited research on phacoemulsification at near physiological IOP and its impact on patient discomfort/pain using the Unity VCS/CS system.
Design:
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to high (IOP 65mmHg) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment.
STUDY HYPOTHESIS Unity VCS/CS with Intelligent Fluidics during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Centurion with Active Sentry at a traditionally high IOP setting | Active Comparator | Centurion with Active Sentry at a traditionally high IOP setting, Eyes in this arm will maintain an Intraocular Pressure (IOP) of 65 millimeters of mercury (mmHg) throughout the cataract surgery. |
|
| Unity VCS/CS with Intelligent Fluidics at a low IOP setting | Active Comparator | Unity VCS/CS with Intelligent Fluidics at a low IOP setting. Eyes in this arm will maintain an Intraocular Pressure (IOP) of 25 millimeters of mercury (mmHg) throughout the cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High IOP Setting | Device | Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue Medication | Percent of pts in each group requiring rescue medication for breakthrough discomfort/pain | During cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Pain Score | Discomfort/pain score at phaco, I/A, visco removal. VAS score : 0 - no pain, 10 - unbearable pain | During Phaco, I/A, and Visco Removal |
| Surgeon Intraoperative Experience | 1- Poor: fluctuating chamber (reverse pupillary block or surge) and reduced efficiency (nucleus & cortex removal)
|
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Inclusion Criteria: Subjects who will require bilateral cataract surgery will be considered. Evaluations will occur in the clinic of the Principal Investigator (PI) Matthew Rauen, MD at the Wolfe Eye Clinic.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robyn Kohler, RN | Contact | 515-223-8685 | rkohler@wolfeclinic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfe Eye Clinic and Wolfe Surgery Center | West Des Moines | Iowa | 50266 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30528516 | Background | Liu YC, Setiawan M, Ang M, Yam GHF, Mehta JS. Changes in aqueous oxidative stress, prostaglandins, and cytokines: Comparisons of low-energy femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. J Cataract Refract Surg. 2019 Feb;45(2):196-203. doi: 10.1016/j.jcrs.2018.09.022. Epub 2018 Dec 6. | |
| Background | Scarfone HA, Rodriquez EC. Evaluation of Early Changes of the Anterior Vitreous Interface after Cataract Surgery, using Low-Pressure Settings Determined by OCT. ASCRS 2023 May 6, San Diego Convention Center. https://ascrs.confex.com/ascrs/23am/meetingapp.cgi/Paper/88373 | ||
| 34860481 |
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We will share informed consent and study protocol.
Will provide with this submission.
No patient specific data analysis will be shared. Will supply copies of IRB approved informed consent and protocol. Inquires to be sent to rkohler@wolfeclinic.com
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 3, 2025 | Oct 30, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 10, 2025 | Oct 20, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Study treatment & Methods:
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| Low IOP Setting | Device | Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment |
|
| During cataract surgery |
| Cost Analysis | Cost-analysis on intraoperative medications utilized in high vs low IOP groups | During cataract surgery |
| Breakthrough pain and discomfort High Axial Length | VAS Pain score on subjects with axial length of >24.5mm VAS score : 0 - no pain, 10 - unbearable pain If patients experienced breakthrough pain during surgery, additional topical anesthetic, intracameral lidocaine, and/or opioid will be used per surgeon discretion and stage of surgery recorded. | During cataract surgery |
| 1 day Post Op Patient Survey |
| 1 day post op cataract surgery, each eye |
| Anesthesiologist Review Blood Pressure | Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional Blood Pressure values at the start of the case (room entry), 4 minutes after versed is administered, during phacoemulsification, and during viscoelastic removal. | During cataract surgery |
| Anesthesiologist Review Pulse Rate | Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional Pulse Rate values at the start of the case (room entry), 4 minutes after versed is administered, during phacoemulsification, and during viscoelastic removal. | During cataract surgery |
| Background |
| Donnenfeld ED, Mychajlyszyn D, Mychajlyszyn A, Stein R. Pain control and reduction of opioid use associated with intracameral phenylephrine1.0%-ketorolac 0.3% administered during cataract surgery. J Cataract Refract Surg. 2022 Jul 1;48(7):759-764. doi: 10.1097/j.jcrs.0000000000000855. Epub 2021 Oct 29. |
| 34737914 | Background | Reddy AJ, Dang A, Dao AA, Arakji G, Cherian J, Brahmbhatt H. A Substantive Narrative Review on the Usage of Lidocaine in Cataract Surgery. Cureus. 2021 Oct 30;13(10):e19138. doi: 10.7759/cureus.19138. eCollection 2021 Oct. |
| 9917782 | Background | Crandall AS, Zabriskie NA, Patel BC, Burns TA, Mamalis N, Malmquist-Carter LA, Yee R. A comparison of patient comfort during cataract surgery with topical anesthesia versus topical anesthesia and intracameral lidocaine. Ophthalmology. 1999 Jan;106(1):60-6. doi: 10.1016/S0161-6420(99)90007-6. |
| 9209989 | Background | Gills JP, Cherchio M, Raanan MG. Unpreserved lidocaine to control discomfort during cataract surgery using topical anesthesia. J Cataract Refract Surg. 1997 May;23(4):545-50. doi: 10.1016/s0886-3350(97)80211-8. |