Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-25 @ 2:11 PM
Study NCT ID:
NCT07223866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-07
First Post:
2025-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage
Sponsor:
Matthew Rauen
Organization:
Study Overview
Official Title:
The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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:
The study will pertain to investigating the impact of high vs low IOP on the intraoperative experience and comfort for the patient and surgeon. Our hypothesis is that operating at a more physiological IOP using Unity VCS/CS and Centurion with Active Sentry at a higher, or more traditional IOP will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.
Detailed Description:
Objective/ Unmet Medical Need:
To investigate the impact of Unity VCS/CS with Intelligent Fluidics at a low IOP setting and Centurion with Active Sentry at a traditionally high IOP setting on the intraoperative experience for the patient and surgeon. Limited research on phacoemulsification at near physiological IOP and its impact on patient discomfort/pain using the Unity VCS/CS system.
Design:
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to high (IOP 65mmHg) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment.
STUDY HYPOTHESIS Unity VCS/CS with Intelligent Fluidics during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.
To investigate the impact of Unity VCS/CS with Intelligent Fluidics at a low IOP setting and Centurion with Active Sentry at a traditionally high IOP setting on the intraoperative experience for the patient and surgeon. Limited research on phacoemulsification at near physiological IOP and its impact on patient discomfort/pain using the Unity VCS/CS system.
Design:
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to high (IOP 65mmHg) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment.
STUDY HYPOTHESIS Unity VCS/CS with Intelligent Fluidics during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: