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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal | Experimental | Arm: Normal eyes Interventions: Galilei Lens Professional, IOLMaster, Lenstar |
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| Mild Cataract | Active Comparator | Arm: Eyes with mild cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar |
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| Severe cataract | Experimental | Arm: Eyes with severe cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galilei Lens Professional | Device | Measurement device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Agreement With Predicate Devices in Terms of Agreement 1 | 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) | 3 months |
| Agreement With Predicate Devices in Terms of Agreement 2 | Assessed Parameters: Simulated Corneal Curvature (SimK; G6, IOLM, LS) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement With Devices of the Same Type in Terms of Repeatability | Assessed parameters: Axial Length (AL) Central Corneal Thickness (CCT) Anterior Chamber Depth (ACD) Lens Thickness (LT) Corneal Curvature (SimK) White-to-White (WtW) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bojan Pajic, MD | Eye Clinic Orasis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Clinic Orasis | Reinach | Canton of Aargau | 5734 | Switzerland |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Device | Galilei Lens Professional versus predicate devices: Galilei G6 Lens Professional (Ziemer Ophthalmic Systems AG) IOLMaster (Carl Zeiss Meditech) Lenstar 900 (Haag-Streit AG) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Device | Galilei Lens Professional versus predicate devices Galilei G6 Lens Professional (Ziemer Ophthalmic Systems AG) IOLMaster (Carl Zeiss Meditech) Lenstar 900 (Haag-Streit AG) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Agreement With Predicate Devices in Terms of Agreement 1 | 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) | 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. | Posted | Mean | Standard Deviation | Units are mm | 3 months | eyes | eyes |
|
3 months
No adverse events were observed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device | Galilei G6 Lens Professional versus IOLMaster and Lenstar |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregor Schmid | Ziemer Ophthalmic Systems AG | +41323327154 | gregor.schmid@ziemergroup.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| IOLMaster | Device | Measurement device |
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| Lenstar | Device | Measurement device |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| eyes |
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| Secondary | Agreement With Devices of the Same Type in Terms of Repeatability | Assessed parameters: Axial Length (AL) Central Corneal Thickness (CCT) Anterior Chamber Depth (ACD) Lens Thickness (LT) Corneal Curvature (SimK) White-to-White (WtW) | 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. | Posted | Number | Coefficient of variation | 3 months | Eyes | Eyes |
|
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| Primary | Agreement With Predicate Devices in Terms of Agreement 2 | Assessed Parameters: Simulated Corneal Curvature (SimK; G6, IOLM, LS) | SimK | Posted | Mean | Standard Deviation | Diopters | 3 months |
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| 0 |
| 40 |
| 0 |
| 40 |
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| Title | Measurements |
|---|
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| CCT G6 |
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| CCT LS |
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| ACD G6 |
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| ACD IOLM |
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| ACD LS |
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| LT G6 |
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| LT LS |
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| SimK G6 |
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| SimK IOLM |
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| SimK LS |
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| WtW G6 |
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| WtW LS |
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| Paired t-test |
| 0.25 |
| Equivalence |
The significance of a difference in a measured parameter between two devices was assessed using a paired t-test |
| P-value comparing SimK between IOLM and LS | Paired t-test | 0.21 | Equivalence | The significance of a difference in a measured parameter between two devices was assessed using a paired t-test |