Trial Outcomes & Findings for What is the Efficiency When Comparing Active Sentry at Low IOP vs Ozil at High IOP? (NCT NCT05868772)

NCT ID: NCT05868772

Last Updated: 2025-04-17

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 36 participants
• Primary outcome timeframe: Day of surgery (Day 0)
• Results posted on: 2025-04-17

Participant Flow

Unit of analysis: eyes

Participant milestones

Measure	Overall (All Participants) Contralateral eye study, flow includes all participants. One eye was randomly assigned to either the Active Sentry or Ozil group and the other eye was assigned to the opposite group.
Overall Study STARTED	36 72
Overall Study Active Sentry	36 36
Overall Study Ozil	36 36
Overall Study COMPLETED	36 72
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall (All Participants) n=36 Participants Contralateral eye study, flow includes all participants
Age, Continuous	71.3 years STANDARD_DEVIATION 6.7 • n=36 Participants
Sex: Female, Male Female	19 Participants n=36 Participants
Sex: Female, Male Male	17 Participants n=36 Participants

PRIMARY outcome

Timeframe: Day of surgery (Day 0)

Outcome measures

Measure	Active Sentry Handpiece n=36 eyes At low IOP settings Active Sentry Handpiece: With low IOP settings	Ozil Handpiece n=36 eyes At high IOP settings Ozil Handpiece: With high IOP settings.
Total Aspiration Time	90.1 seconds Standard Deviation 16.4	85.1 seconds Standard Deviation 17.0

SECONDARY outcome

Timeframe: Day of surgery (Day 0)

Outcome measures

Measure	Active Sentry Handpiece n=36 eyes At low IOP settings Active Sentry Handpiece: With low IOP settings	Ozil Handpiece n=36 eyes At high IOP settings Ozil Handpiece: With high IOP settings.
Total Fluid Volume	32.8 mL Standard Deviation 4.6	33.8 mL Standard Deviation 6.0

SECONDARY outcome

Timeframe: Day of surgery (Day 0)

Outcome measures

Measure	Active Sentry Handpiece n=36 eyes At low IOP settings Active Sentry Handpiece: With low IOP settings	Ozil Handpiece n=36 eyes At high IOP settings Ozil Handpiece: With high IOP settings.
Total Phaco Time	29.5 seconds Standard Deviation 7.3	31.0 seconds Standard Deviation 7.4

SECONDARY outcome

Timeframe: 1 week postoperative

Outcome measures

Measure	Active Sentry Handpiece n=36 eyes At low IOP settings Active Sentry Handpiece: With low IOP settings	Ozil Handpiece n=36 eyes At high IOP settings Ozil Handpiece: With high IOP settings.
Central Corneal Thickness	554.9 um Standard Deviation 27.6	555.5 um Standard Deviation 28.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Day of surgery (Day 0)

CDE is the amount of ultrasound energy used to remove a cataractous lens. CDE is the power and time of torsional and longitudinal ultrasound delivery modes. It is not expressed in standard units, but is generally unitless. CDE is calculated by the Centurion® Vision System automatically. A lower value is indicative of lower energy used in the eye.

Outcome measures

Measure	Active Sentry Handpiece n=36 eyes At low IOP settings Active Sentry Handpiece: With low IOP settings	Ozil Handpiece n=36 eyes At high IOP settings Ozil Handpiece: With high IOP settings.
Cumulative Dissipated Energy (CDE)	5.0 unitless Standard Deviation 1.9	5.2 unitless Standard Deviation 1.7

Adverse Events

Active Sentry Handpiece

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ozil Handpiece

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active Sentry Handpiece n=36 participants at risk With low IOP settings	Ozil Handpiece n=36 participants at risk With high IOP settings
Eye disorders corneal edema	0.00% 0/36 • 1 week	2.8% 1/36 • 1 week
Eye disorders iritis	0.00% 0/36 • 1 week	2.8% 1/36 • 1 week
Eye disorders Elevated IOP	2.8% 1/36 • 1 week	2.8% 1/36 • 1 week

Additional Information

Dr Justin Spaulding

Cataract & Laser Institute

Phone: 541-779-2020

Email: justinophtho@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place