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Trial Outcomes & Findings for The Cutting Efficiency of Hybrid Tips in Different Grades of Cataract (NCT NCT05495555)

NCT ID: NCT05495555

Last Updated: 2025-03-11

Results Overview

Recruitment status

COMPLETED

Target enrollment

51 participants

Primary outcome timeframe

Day 0 (surgical visit)

Results posted on

2025-03-11

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure
High IOP Setting
Cataract removal with high IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Low IOP Setting
Cataract removal with low IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Overall Study
STARTED
51 51
51 51
Overall Study
COMPLETED
51 51
51 51
Overall Study
NOT COMPLETED
0 0
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=51 Participants
All participants.
Age, Continuous
75.8 years
STANDARD_DEVIATION 6.7 • n=51 Participants
Sex: Female, Male
Female
31 Participants
n=51 Participants
Sex: Female, Male
Male
20 Participants
n=51 Participants
Region of Enrollment
United States
51 participants
n=51 Participants

PRIMARY outcome

Timeframe: Day 0 (surgical visit)

Outcome measures

Outcome measures
Measure
High IOP Setting
n=51 Eyes
Cataract removal with high IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Low IOP Setting
n=51 Eyes
Cataract removal with low IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Phaco Time
41.6 seconds
Standard Deviation 10
41.8 seconds
Standard Deviation 10.2

PRIMARY outcome

Timeframe: Day 0 (surgical visit)

Outcome measures

Outcome measures
Measure
High IOP Setting
n=51 Eyes
Cataract removal with high IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Low IOP Setting
n=51 Eyes
Cataract removal with low IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Aspiration Time
101.7 seconds
Standard Deviation 27.2
106.7 seconds
Standard Deviation 25.3

PRIMARY outcome

Timeframe: Day 0 (surgical visit)

Outcome measures

Outcome measures
Measure
High IOP Setting
n=51 Eyes
Cataract removal with high IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Low IOP Setting
n=51 Eyes
Cataract removal with low IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Fluid Use
41.6 mL
Standard Deviation 9.0
40.2 mL
Standard Deviation 7.8

SECONDARY outcome

Timeframe: baseline and 1 week postoperative

Outcome measures

Outcome measures
Measure
High IOP Setting
n=51 Eyes
Cataract removal with high IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Low IOP Setting
n=51 Eyes
Cataract removal with low IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Central Corneal Thickness Change From Baseline
5.4 µm
Standard Deviation 5.1
8.1 µm
Standard Deviation 8.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (surgical visit)

This will measure the the amount of ultrasound energy used during cataract removal

Outcome measures

Outcome measures
Measure
High IOP Setting
n=51 Eyes
Cataract removal with high IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Low IOP Setting
n=51 Eyes
Cataract removal with low IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Cumulative Dissipated Energy
8.7 µJ
Standard Deviation 3.1
8.6 µJ
Standard Deviation 3.4

Adverse Events

High IOP Setting

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Low IOP Setting

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
High IOP Setting
n=51 participants at risk
Cataract removal with high IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Low IOP Setting
n=51 participants at risk
Cataract removal with low IOP setting INTREPID® Hybrid tip: INTREPID® Hybrid tip for cataract removal
Eye disorders
Elevated IOP
5.9%
3/51 • Number of events 3 • 1 week
5.9%
3/51 • Number of events 3 • 1 week

Additional Information

Dr Justin Spaulding

Cataract & Laser Institute

Phone: 541-779-2020

Results disclosure agreements

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