NCT05765201

Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Physiology

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: Matthew Rauen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the anterior and posterior structure and functional changes and vascular alterations when performing phacoemulsification at high IOP vs low, more physiological IOP using Centurion® Vision System with Active Sentry® handpiece. These devices are approved by the US Food and Drug Administration (FDA).

Detailed description

To investigate the anterior and posterior physiological changes when performing phacoemulsification at high IOP vs low, more physiologic IOP using Centurion® Vision System with Active Sentry® handpiece Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye Operating at lower, more physiological IOP using Active Sentry® handpiece during cataract surgery will use less BSS fluid usage. (Lower IOP settings are also expected to result in less subclinical changes).

Conditions

• Nuclear Cataract

Interventions

Type	Name	Description
OTHER	High IOP	Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye
OTHER	Low IOP	Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye

Timeline

• Start date: 2022-09-22
• Primary completion: 2023-05-04
• Completion: 2023-05-04
• First posted: 2023-03-13
• Last updated: 2024-01-08

Locations

1 site across 1 country: United States