Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)

Nuclear Cataract Clinical Trial

Official title:

Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325397
• Other study ID #: IIT #88313865
• Status: Recruiting
• Start date: October 23, 2023
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Wolfe Eye Clinic
• Contact: Robyn Kohler, RN
• Phone: 515-223-8685
• Email: rkohler[@]wolfeclinic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Nuclear Cataract

Intervention

Other:
• High Intraocular Pressure (IOP)
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.
• Low Intraocular Pressure (IOP)
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

Locations

Country	Name	City	State
United States	Wolfe Eye Clinic	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Matthew Rauen

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Rescue	Percentage (%) of pts in each group requiring treatment for breakthrough discomfort/pain	Intraoperative
Secondary	Physiologic Responses associated with pain/inflammation:	Blood pressure- measured systolic pressure over the diastolic pressure	Intraoperative
Secondary	Physiologic Responses associated with pain/inflammation:	Pulse rate- measured in beats per minute (bpm)	Intraoperative
Secondary	Surgeon Experience: Assessment on patient cooperation	Surgeon assessment on patient cooperation: poor, good, excellent; Poor cooperation: could not follow instructions, lid squeezing, patient had frequent eye & head movements; Good cooperation: able to follow directions 50% of the time, some lid squeezing and patient movement; Excellent cooperation: able to follow directions >80% of the time with limited lid squeezing and patient movement	Intraoperative
Secondary	Surgeon Experience: Surgeon intraoperative experience	Surgeon assessment on overall experience: poor, good, excellent; Poor: fluctuating chamber (reverse pupillary block or surge) and reduced efficiency (nucleus & cortex removal); Good: >75% chamber stability and adequate efficiency; Excellent: Minimal to no fluctuating chamber and excellent efficiency	Intraoperative
Secondary	Cost- analysis	Cost-analysis on intraoperative pharmacological agents utilized between high vs low Intraocular Pressure (IOP)	Intraoperative