Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325397
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-01-04
Brief Title:
Less Discomfort and Less Pharmacology Cataract Surgery at Physiologic Intraocular Pressure IOP
Sponsor:
Matthew Rauen
Organization:
Wolfe Eye Clinic
Study Overview
Official Title:
Less Discomfort and Less Pharmacology Cataract Surgery at Physiologic Intraocular Pressure IOP
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 discomfortpain 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 subjects 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 discomfortpain as assessed by the decreased need for rescue medication
To investigate the impact of Intraocular Pressure IOP high vs low on the intraoperative experience for the patient and surgeon
Design
Prospective single-surgeon subjects 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 discomfortpain as assessed by the decreased need for rescue medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None