Cataract
Conditions
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.
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.
Interventions
Sponsors
Ziemer Ophthalmic Systems AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Agreement With Predicate Devices in Terms of Agreement 2 | 3 months | Assessed Parameters: Simulated Corneal Curvature (SimK; G6, IOLM, LS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Switzerland
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.
Participants by arm
| Arm | Count |
|---|---|
| Device Galilei Lens Professional versus predicate devices
Galilei G6 Lens Professional (Ziemer Ophthalmic Systems AG) IOLMaster (Carl Zeiss Meditech) Lenstar 900 (Haag-Streit AG) | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 58.8 years STANDARD_DEVIATION 18.9 |
| Region of Enrollment Switzerland | 40 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device | Agreement With Predicate Devices in Terms of Agreement 1 | AL G6-IOLM | -0.010 Units are mm | Standard Deviation 0.049 |
| Device | Agreement With Predicate Devices in Terms of Agreement 1 | AL G6-LS | -0.023 Units are mm | Standard Deviation 0.048 |
| Device | Agreement With Predicate Devices in Terms of Agreement 1 | AL IOLM-LS | -0.014 Units are mm | Standard Deviation 0.02 |
| Device | Agreement With Predicate Devices in Terms of Agreement 1 | CCT G6-LS | 0.005 Units are mm | Standard Deviation 0.008 |
| Device | Agreement With Predicate Devices in Terms of Agreement 1 | ACD G6-IOLM | 0.137 Units are mm | Standard Deviation 0.104 |
| Device | Agreement With Predicate Devices in Terms of Agreement 1 | ACD G6-LS | 0.052 Units are mm | Standard Deviation 0.168 |
| Device | Agreement With Predicate Devices in Terms of Agreement 1 | ACD IOLM-LS | -0.087 Units are mm | Standard Deviation 0.22 |
| Device | Agreement With Predicate Devices in Terms of Agreement 1 | LT G6-LS | 0.070 Units are mm | Standard Deviation 0.256 |
| Device | Agreement With Predicate Devices in Terms of Agreement 1 | WtW G6-IOLM | 0.150 Units are mm | Standard Deviation 0.199 |
| Device | Agreement With Predicate Devices in Terms of Agreement 1 | WtW G6-LS | -0.121 Units are mm | Standard Deviation 0.173 |
| Device | Agreement With Predicate Devices in Terms of Agreement 1 | WtW IOLM-LS | -0.276 Units are mm | Standard Deviation 0.191 |
Comparison: P-value comparing AL between G6 and IOLMp-value: 0.09Paired t-test
Comparison: P-value comparing AL between G6 and LSp-value: <0.001Paired t-test
Comparison: P-value comparing AL between IOLM and LSp-value: <0.0001Paired t-test
Comparison: P-value comparing CCT between G6 and LSp-value: <0.0001Paired t-test
Comparison: P-value comparing ACD between G6 and IOLMp-value: <0.0001Paired t-test
Comparison: P-value comparing ACD between G6 and LSp-value: <0.01Paired t-test
Comparison: P-value comparing ACD between IOLM and LSp-value: 0.02Paired t-test
Comparison: P-value comparing LT between G6 and LSp-value: <0.01Paired t-test
Comparison: P-value comparing WtW between G6 and IOLMp-value: <0.0001Paired t-test
Comparison: P-value comparing WtW between G6 and LSp-value: <0.0001Paired t-test
Comparison: P-value comparing WtW between IOLM and LSp-value: <0.001Paired t-test
Primary
Agreement With Predicate Devices in Terms of Agreement 2
Assessed Parameters: Simulated Corneal Curvature (SimK; G6, IOLM, LS)
Time frame: 3 months
Population: SimK
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device | Agreement With Predicate Devices in Terms of Agreement 2 | SimK G6-IOLM | -0.031 Diopters | Standard Deviation 0.247 |
| Device | Agreement With Predicate Devices in Terms of Agreement 2 | SimK G6-LS | -0.033 Diopters | Standard Deviation 0.326 |
| Device | Agreement With Predicate Devices in Terms of Agreement 2 | SimK IOLM-LS | 0.008 Diopters | Standard Deviation 0.198 |
Comparison: P-value comparing SimK between G6 and IOLMp-value: 0.13Paired t-test
Comparison: P-value comparing SimK between G6 and LSp-value: 0.25Paired t-test
Comparison: P-value comparing SimK between IOLM and LSp-value: 0.21Paired t-test
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)
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | WtW LS | 0.0042 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | AL G6 | 0.0018 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | AL IOLM | 0.0010 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | AL LS | 0.0008 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | CCT G6 | 0.0040 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | CCT LS | 0.0082 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | ACD G6 | 0.0259 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | ACD IOLM | 0.0084 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | ACD LS | 0.0391 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | LT G6 | 0.0394 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | LT LS | 0.0262 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | SimK G6 | 0.0028 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | SimK IOLM | 0.0024 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | SimK LS | 0.0050 Coefficient of variation |
| Device | Agreement With Devices of the Same Type in Terms of Repeatability | WtW G6 | 0.0149 Coefficient of variation |
Comparison: 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.p-value: 0.05ANOVA