Trial Outcomes & Findings for Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines (NCT NCT02910362)

Results Overview

Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

intraoperative

Results posted on

2018-10-11

Participant Flow

From September 2016 until December 2016,15 patients were enrolled at Arizona Eye Consultants clinic

Patients were included in the study based upon meeting inclusion criteria and not meeting exclusion criteria. Patients were randomized to either group based upon a random number generator.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Alcon Phacoemulsification Equipment cataract surgery performed with the Alcon phacoemulsification equipment Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment.	AMO Phacoemulsification Equipment cataract surgery with the AMO phacoemulsification equipment AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment.
Overall Study STARTED	8 16	7 14
Overall Study COMPLETED	8 16	7 14
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alcon Phacoemulsification Equipment n=16 Eyes cataract surgery performed with the Alcon phacoemulsification equipment Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment.	AMO Phacoemulsification Equipment n=14 Eyes cataract surgery with the AMO phacoemulsification equipment AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment.	Total n=30 Eyes Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 8 • n=99 Participants	66 years STANDARD_DEVIATION 8 • n=107 Participants	66 years STANDARD_DEVIATION 8 • n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	4 Participants n=107 Participants	9 Participants n=206 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Region of Enrollment United States	8 Participants n=99 Participants	7 Participants n=107 Participants	15 Participants n=206 Participants

PRIMARY outcome

Timeframe: intraoperative

Population: Eyes with stable IOP

Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.

Outcome measures

Outcome measures
Measure	Alcon Phacoemulsification Equipment n=16 Eyes cataract surgery performed with the Alcon phacoemulsification equipment Alcon phacoemulsification equipment: cataract surgery with Alcon phacoemulsification equipment.	AMO Phacoemulsification Equipment n=14 Eyes cataract surgery with the AMO phacoemulsification equipment AMO phacoemulsification equipment: cataract surgery with AMO phacoemulsification equipment.
Number of Eyes With Stable IOP	16 Eyes	14 Eyes

Adverse Events

Alcon Phacoemulsification Equipment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AMO Phacoemulsification Equipment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sean McCafferty, MD

Arizona Eye Consultants

Phone: (520) 791-7401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60