Galilei Lens Professional vs. Predicate Devices: a Comparison Study

• Sponsor: Ziemer Ophthalmic Systems AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01961089
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 20

Study Details

Study Description

Brief Summary

Study question: How does the new GALILEI Lens Professional compare to predicate devices? Study hypothesis: The GALILEI Lens Professional achieves a better precision in the postoperative, calculated target refraction with cataract surgeries than predicate devices, and it is more versatile in the measurable parameters as well as more user-friendly.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Galilei Lens Professional; Device: IOLMaster; Device: Lenstar	N/A

Detailed Description

Background: An accessory to the commercially available GALILEI Dual-Scheimpflug Corneal Topographer/Keratometer with the name "EBR Accessory" was developed by the company Ziemer Ophthalmic Systems AG for the measurement of intraocular distances. The combination is called "GALILEI Lens Professional". The measurement principle is based on on short coherence interferometry/-reflectometry, which has gained wide-spread application and has been applied clinically, including one of the members of this study group, for the precise measurement of axial, intraocular distances (12.1.). Such EBR Accessory measurements, in combination with measurements by the GALILEI, may be applied to given intra-ocular lens (IOL) types and IOL equations, an permit the calculation of suggested IOLs that are implanted during cataract surgery, in order to achieve the desired vision correction. To register this accessory for sale, the precision and agreement to existing devices with similar applications ("predicate devices") must be demonstrated. One complete measurement consists of a cornea-topography/keratometry scan, followed immediately by three consecutive, axial biometry scans of the anterior segment (cornea and crystalline lens) and - after a short re-alignment

• three consecutive, axial biometry scans of the retina. The measurement process is continuous, but divided in two steps. Blinking by the patient is possible in between the two steps, which increases patient comfort and, in certain cases, measurement success. Precision is evaluated by three repeated, complete measurements with the GALILEI Lens Professional and each predicate device. Two standard devices with comparable optical technology that are used in routine cataract surgery were declared as predicate devices. These two devise are typically used in combination with standard keratometers, as which the GALILEI Lens Professional may be employed as well.

Goal: The comparison of the GALILEI Lens Professional to predicate devices with respect to precision in measuring postoperative, calculated target refractions in cataract patients, and versatility of measurable quantities.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: GALILEI Lens Professional vs. Predicate Devices: a Comparison Study
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal Arm: Normal eyes Interventions: Galilei Lens Professional, IOLMaster, Lenstar	Device: Galilei Lens Professional; Measurement device; Device: IOLMaster; Measurement device; Device: Lenstar; Measurement device
Active Comparator: Mild Cataract Arm: Eyes with mild cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar	Device: Galilei Lens Professional; Measurement device; Device: IOLMaster; Measurement device; Device: Lenstar; Measurement device
Experimental: Severe cataract Arm: Eyes with severe cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar	Device: Galilei Lens Professional; Measurement device; Device: IOLMaster; Measurement device; Device: Lenstar; Measurement device

Outcome Measures

Primary Outcome Measures

1. Agreement With Predicate Devices in Terms of Agreement 1 [3 months]

   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)

2. Agreement With Predicate Devices in Terms of Agreement 2 [3 months]

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

Secondary Outcome Measures

1. Agreement With Devices of the Same Type in Terms of Repeatability [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• spherical equivalent between -10 D and +10 D

• best-corrected VA of 20/100 or better.

Exclusion Criteria:

• strabism

• blepharitis

• nystagmus

• amblyopia

• anisometropia (spherical equivalent > 1D)

• angle closure glaucoma

• seizure disorder

• brain damages

• Down syndrome

• trisomy 13 or 18

• cerebral palsy

• other serious disorders of the eye or central nervous systems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Clinic Orasis	Reinach	Aargau	Switzerland	5734

Sponsors and Collaborators

• Ziemer Ophthalmic Systems AG

Investigators

• Principal Investigator: Bojan Pajic, MD, Eye Clinic Orasis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ziemer Ophthalmic Systems AG
• ClinicalTrials.gov Identifier: NCT01961089
• Other Study ID Numbers: ZIOS-13/01
• First Posted: Oct 11, 2013
• Last Update Posted: Oct 8, 2019
• Last Verified: Sep 1, 2019

• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Device
Arm/Group Description	Galilei Lens Professional versus predicate devices: Galilei G6 Lens Professional (Ziemer Ophthalmic Systems AG) IOLMaster (Carl Zeiss Meditech) Lenstar 900 (Haag-Streit AG)
Period Title: Overall Study
STARTED	40
COMPLETED	40
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Device
Arm/Group Description	Galilei Lens Professional versus predicate devices Galilei G6 Lens Professional (Ziemer Ophthalmic Systems AG) IOLMaster (Carl Zeiss Meditech) Lenstar 900 (Haag-Streit AG)
Overall Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	21 52.5%
>=65 years	19 47.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.8 (18.9)
Sex: Female, Male (Count of Participants)
Female	29 72.5%
Male	11 27.5%
Region of Enrollment (participants) [Number]
Switzerland	40 100%

Outcome Measures

1. Primary Outcome

Title	Agreement With Predicate Devices in Terms of Agreement 1
Description	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)
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Device
Arm/Group Description	Galilei Lens G6 Professional (G6) versus IOLMaster (IOLM) and Lenstar 900 (LS)
Measure Participants	40
Measure eyes	72
AL G6-IOLM	-0.010 (0.049)
AL G6-LS	-0.023 (0.048)
AL IOLM-LS	-0.014 (0.020)
CCT G6-LS	0.005 (0.008)
ACD G6-IOLM	0.137 (0.104)
ACD G6-LS	0.052 (0.168)
ACD IOLM-LS	-0.087 (0.220)
LT G6-LS	0.070 (0.256)
WtW G6-IOLM	0.150 (0.199)
WtW G6-LS	-0.121 (0.173)
WtW IOLM-LS	-0.276 (0.191)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing AL between G6 and IOLM
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test.
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing AL between G6 and LS
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing AL between IOLM and LS
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing CCT between G6 and LS
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing ACD between G6 and IOLM
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing ACD between G6 and LS
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing ACD between IOLM and LS
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing LT between G6 and LS
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing WtW between G6 and IOLM
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing WtW between G6 and LS
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing WtW between IOLM and LS
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Paired t-test
	Comments

2. Secondary Outcome

Title	Agreement With Devices of the Same Type in Terms of Repeatability
Description	Assessed parameters: Axial Length (AL) Central Corneal Thickness (CCT) Anterior Chamber Depth (ACD) Lens Thickness (LT) Corneal Curvature (SimK) White-to-White (WtW)
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Device
Arm/Group Description	Galilei Lens G6 Professional (G6) versus IOLMaster (IOLM) and Lenstar 900 (LS)
Measure Participants	40
Measure Eyes	80
AL G6	0.0018
AL IOLM	0.0010
AL LS	0.0008
CCT G6	0.0040
CCT LS	0.0082
ACD G6	0.0259
ACD IOLM	0.0084
ACD LS	0.0391
LT G6	0.0394
LT LS	0.0262
SimK G6	0.0028
SimK IOLM	0.0024
SimK LS	0.0050
WtW G6	0.0149
WtW LS	0.0042

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	Repeatability was determined with random effect ANOVAs (estimates of random effects). They were calculated as the square root of the sum of the (Device x EyeID) interaction component plus (EyeID) and (Device) variance components plus the residual variance component. A (Device x Operator) interaction component was not assessed because each device was consistently operated by the same operator such that there was no Device x Operator interaction component. CV = Coefficient of Variation = SD/mean.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANOVA
	Comments

3. Primary Outcome

Title	Agreement With Predicate Devices in Terms of Agreement 2
Description	Assessed Parameters: Simulated Corneal Curvature (SimK; G6, IOLM, LS)
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

SimK

Arm/Group Title	Device
Arm/Group Description	Galilei Lens G6 Professional (G6) versus IOLMaster (IOLM) and Lenstar 900 (LS)
Measure Participants	40
SimK G6-IOLM	-0.031 (0.247)
SimK G6-LS	-0.033 (0.326)
SimK IOLM-LS	0.008 (0.198)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing SimK between G6 and IOLM
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing SimK between G6 and LS
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Device
	Comments	P-value comparing SimK between IOLM and LS
	Type of Statistical Test	Equivalence
	Comments	The significance of a difference in a measured parameter between two devices was assessed using a paired t-test
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	Paired t-test
	Comments

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	No adverse events were observed
Arm/Group Title	Device
Arm/Group Description	Galilei G6 Lens Professional versus IOLMaster and Lenstar
All Cause Mortality
	Device
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Device
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Other (Not Including Serious) Adverse Events
	Device
	Affected / at Risk (%)	# Events
Total	0/40 (0%)

Limitations/Caveats

Due to the the removal and non-repetition of poor-quality G6 measurements, the informative value of the repeatability results is limited. Direct comparison to the predicates is problematic, as poor-quality measurements with those were repeated.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.