Clinical trial NCT06325397: Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)
Official title: Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nuclear Cataract
Lead sponsor: Wolfe Eye Clinic
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 75 cataract surgery patients from ophthalmology clinic

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery
* Unremarkable ocular health but inclusive of early Age related macular degeneration (AMD).

Exclusion Criteria:

* History of ocular surgery including corneal refractive surgery
* Compromised zonular integrity or stability
* Uncontrolled diabetes and diabetic retinopathy
* Small pupils
* History of systemic inflammatory disease/uveitis
* History of psychiatric illness, chronic pain/narcotics, benzodiazepine usage
* Abnormal liver or renal function

Primary outcomes:
measure: Medication Rescue
timeFrame: Intraoperative
Secondary outcomes:
measure: Physiologic Responses associated with pain/inflammation:
timeFrame: Intraoperative
measure: Physiologic Responses associated with pain/inflammation:
timeFrame: Intraoperative
measure: Surgeon Experience: Assessment on patient cooperation
timeFrame: Intraoperative
measure: Surgeon Experience: Surgeon intraoperative experience
timeFrame: Intraoperative
measure: Cost- analysis
timeFrame: Intraoperative
Other outcomes:
Locations:
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.