Trial Outcomes & Findings for Clinical Comparison of Length of Cataract Procedures With Zeiss Lumera Versus Older Zeiss Microscope (NCT NCT03298841)

NCT ID: NCT03298841

Last Updated: 2021-04-22

Results Overview

operating times during cataract surgery will be measured with the use of the new Lumera operating microscope versus an older Zeiss model operating scope by two experienced cataract surgeons in a single surgery center

• Recruitment status: COMPLETED
• Target enrollment: 50 participants
• Primary outcome timeframe: during surgery assessed up to one hour
• Results posted on: 2021-04-22

Participant Flow

Participant milestones

Measure	Zeiss Group patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software	Leica Stativ S3B patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
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	Zeiss Group n=25 Participants patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software	Leica Stativ S3B n=25 Participants patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=25 Participants	23 Participants n=25 Participants	45 Participants n=50 Participants
Age, Categorical >=65 years	3 Participants n=25 Participants	2 Participants n=25 Participants	5 Participants n=50 Participants
Sex: Female, Male Female	15 Participants n=25 Participants	16 Participants n=25 Participants	31 Participants n=50 Participants
Sex: Female, Male Male	10 Participants n=25 Participants	9 Participants n=25 Participants	19 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	25 participants n=25 Participants	25 participants n=25 Participants	50 participants n=50 Participants

PRIMARY outcome

Timeframe: during surgery assessed up to one hour

Population: patients undergoing uncomplicated phacoemulsification by two surgeons at one surgery site

operating times during cataract surgery will be measured with the use of the new Lumera operating microscope versus an older Zeiss model operating scope by two experienced cataract surgeons in a single surgery center

Outcome measures

Measure	Zeiss Group n=25 Participants patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software	Leica Stativ S3B n=25 Participants patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope
Improvement in Operating Room Efficiencies During Cataract Surgery With the Use of the New Lumera Operating Microscope Versus an Older Zeiss Model Operating Scope	11.15 minutes per surgical procedure Standard Deviation 2.42	14.18 minutes per surgical procedure Standard Deviation 8.67

SECONDARY outcome

Timeframe: 6 weeks

Population: patients scheduled for routine cataract surgery with one of two experienced surgeons

events that are life or vision threatening, that require hospitalization or permanent disability of any type

Outcome measures

Measure	Zeiss Group n=50 Participants patients undergoing uncomplicated phacoemulsification using Zeiss Lumera microscope with Callisto software	Leica Stativ S3B patients undergoing uncomplicated phacoemulsification using Leica Stativ S3B microscope
Number of Serious Adverse Events During Intra-operative and Post-operative Period	0 Participants	—

Adverse Events

Zeiss Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Leica Stativ S3B

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

Melissa Toyos

Toyos Clinic

Phone: 6153274015

Email: mtoyos@toyosclinic.com

Results disclosure agreements

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