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To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication
Objectives:
To investigate the impact of Intraocular Pressure (IOP) high vs low on the intraoperative experience for the patient and surgeon
Design:
Prospective, single-surgeon, subject's first eyes undergoing phacoemulsification will be randomized to high (Intraocular Pressure (IOP) 65 millimeters of mercury (mmHg)) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment
Hypothesis:
Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intraocular Pressure (IOP) | Eyes in this arm will maintain an Intraocular Pressure (IOP) of 65 millimeters of mercury (mmHg) throughout the cataract surgery. |
| |
| Low Intraocular Pressure (IOP) | Eyes in this arm will maintain an Intraocular Pressure (IOP) of 24 millimeters of mercury (mmHg) throughout the cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intraocular Pressure (IOP) | Other | Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with Intraocular Pressure (IOP) ≤ 24 millimeters of mercury (mmHg) (low IOP) in one eye and with IOP ≥ 65 millimeters of mercury (mmHg) (high IOP) in the other eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Rescue | Percentage (%) of pts in each group requiring treatment for breakthrough discomfort/pain | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Physiologic Responses associated with pain/inflammation: | Blood pressure- measured systolic pressure over the diastolic pressure | Intraoperative |
| Physiologic Responses associated with pain/inflammation: |
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Inclusion Criteria:
Exclusion Criteria:
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75 cataract surgery patients from ophthalmology clinic
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9209989 | Result | 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. | |
| 9917782 | Result | 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. |
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|
| Low Intraocular Pressure (IOP) | Other | Low Intraocular Pressure (IOP) Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 24 millimeters of mercury (mmHg) (low IOP) in one eye and with IOP ≥ 65 millimeters of mercury (mmHg) (high IOP) in the other eye |
|
Pulse rate- measured in beats per minute (bpm)
| Intraoperative |
| Surgeon Experience: Assessment on patient cooperation | Surgeon assessment on patient cooperation: poor, good, excellent
| Intraoperative |
| Surgeon Experience: Surgeon intraoperative experience | Surgeon assessment on overall experience: poor, good, excellent
| Intraoperative |
| Cost- analysis | Cost-analysis on intraoperative pharmacological agents utilized between high vs low Intraocular Pressure (IOP) | Intraoperative |
| 34737914 | Result | 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. |