NCT06325397

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Matthew Rauen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Conditions

• Nuclear Cataract

Interventions

Type	Name	Description
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.
OTHER	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

Timeline

• Start date: 2024-03-18
• Primary completion: 2024-12-20
• Completion: 2025-04-01
• First posted: 2024-03-22
• Last updated: 2025-05-21

Locations

1 site across 1 country: United States