Trial Outcomes & Findings for Galilei Lens Professional vs. Predicate Devices: a Comparison Study (NCT NCT01961089)

NCT ID: NCT01961089

Last Updated: 2019-10-08

Results Overview

Assessed parameters: Axial Length (AL; G6, IOLM, LS) Central Corneal Thickness (CCT; G6, LS)) Anterior Chamber Depth (ACD; G6, IOLM, LS) Lens Thickness (LT; G6, LS) Corneal Curvature (SimK; G6, IOLM, LS) White-to-White (WtW; G6, IOL, LS)

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

3 months

Results posted on

2019-10-08

Participant Flow

40 adult subjects were recruited from among patients seen at the ORASIS eye clinics, including 20 people with cataract in at least one eye and 20 subjects without cataract. The subjects included 5 people with prior refractive surgery, 5 people with high myopia, 5 people with high hyperopia, and 3 persons with dilated pupils.

Participant milestones

Participant milestones
Measure	Device Galilei Lens Professional versus predicate devices: Galilei G6 Lens Professional (Ziemer Ophthalmic Systems AG) IOLMaster (Carl Zeiss Meditech) Lenstar 900 (Haag-Streit AG)
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Galilei Lens Professional vs. Predicate Devices: a Comparison Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Device n=40 Participants Galilei Lens Professional versus predicate devices Galilei G6 Lens Professional (Ziemer Ophthalmic Systems AG) IOLMaster (Carl Zeiss Meditech) Lenstar 900 (Haag-Streit AG)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Age, Continuous	58.8 years STANDARD_DEVIATION 18.9 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment Switzerland	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The measurement of Central Corneal Thickness (CCT) and Lens Thickness (LT) is not possible with the IOLM: the IOLM cannot measure these two parameters and does therefore not display results for CCT and LT. As a consequence, the comparison in CCT and LT is only possible between the G6 and the LS, but not with respect to the IOLM.

Outcome measures

Outcome measures
Measure	Device n=72 eyes Galilei Lens G6 Professional (G6) versus IOLMaster (IOLM) and Lenstar 900 (LS)
Agreement With Predicate Devices in Terms of Agreement 1 AL G6-IOLM	-0.010 Units are mm Standard Deviation 0.049
Agreement With Predicate Devices in Terms of Agreement 1 AL G6-LS	-0.023 Units are mm Standard Deviation 0.048
Agreement With Predicate Devices in Terms of Agreement 1 AL IOLM-LS	-0.014 Units are mm Standard Deviation 0.020
Agreement With Predicate Devices in Terms of Agreement 1 CCT G6-LS	0.005 Units are mm Standard Deviation 0.008
Agreement With Predicate Devices in Terms of Agreement 1 ACD G6-IOLM	0.137 Units are mm Standard Deviation 0.104
Agreement With Predicate Devices in Terms of Agreement 1 ACD G6-LS	0.052 Units are mm Standard Deviation 0.168
Agreement With Predicate Devices in Terms of Agreement 1 ACD IOLM-LS	-0.087 Units are mm Standard Deviation 0.220
Agreement With Predicate Devices in Terms of Agreement 1 LT G6-LS	0.070 Units are mm Standard Deviation 0.256
Agreement With Predicate Devices in Terms of Agreement 1 WtW G6-IOLM	0.150 Units are mm Standard Deviation 0.199
Agreement With Predicate Devices in Terms of Agreement 1 WtW G6-LS	-0.121 Units are mm Standard Deviation 0.173
Agreement With Predicate Devices in Terms of Agreement 1 WtW IOLM-LS	-0.276 Units are mm Standard Deviation 0.191

PRIMARY outcome

Timeframe: 3 months

Population: SimK

Assessed Parameters: Simulated Corneal Curvature (SimK; G6, IOLM, LS)

Outcome measures

Outcome measures
Measure	Device n=40 Participants Galilei Lens G6 Professional (G6) versus IOLMaster (IOLM) and Lenstar 900 (LS)
Agreement With Predicate Devices in Terms of Agreement 2 SimK G6-IOLM	-0.031 Diopters Standard Deviation 0.247
Agreement With Predicate Devices in Terms of Agreement 2 SimK G6-LS	-0.033 Diopters Standard Deviation 0.326
Agreement With Predicate Devices in Terms of Agreement 2 SimK IOLM-LS	0.008 Diopters Standard Deviation 0.198

SECONDARY outcome

Timeframe: 3 months

Population: The IOLM does not measure CCT and LT. Thus, repeatability results are available with the G6 and the LS, but not with the IOLM. The IOL Master displays one average value only for WtW, which does not permit the calculation of repeatability under the present study design.

Assessed parameters: Axial Length (AL) Central Corneal Thickness (CCT) Anterior Chamber Depth (ACD) Lens Thickness (LT) Corneal Curvature (SimK) White-to-White (WtW)

Outcome measures

Outcome measures
Measure	Device n=80 Eyes Galilei Lens G6 Professional (G6) versus IOLMaster (IOLM) and Lenstar 900 (LS)
Agreement With Devices of the Same Type in Terms of Repeatability AL G6	0.0018 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability AL IOLM	0.0010 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability AL LS	0.0008 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability CCT G6	0.0040 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability CCT LS	0.0082 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability ACD G6	0.0259 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability ACD IOLM	0.0084 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability ACD LS	0.0391 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability LT G6	0.0394 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability LT LS	0.0262 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability SimK G6	0.0028 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability SimK IOLM	0.0024 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability SimK LS	0.0050 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability WtW G6	0.0149 Coefficient of variation
Agreement With Devices of the Same Type in Terms of Repeatability WtW LS	0.0042 Coefficient of variation

Adverse Events

Device

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

Dr. Gregor Schmid

Ziemer Ophthalmic Systems AG

Phone: +41323327154

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place