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| Name | Class |
|---|---|
| Insel Gruppe AG, University Hospital Bern | OTHER |
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The purpose of this study is to quantify in-vivo repeatability of a new corneal topography measurement mode of an optical biometer, and the clinical performance of measurement in comparison to reference devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal eye | Astigmatism smaller than 1.5 diopters | ||
| Large regular astigmatism | Astigmatism of > 1.5 diopters, regular astigmatism. | ||
| Large irregular astigmatism | Astigmatism of > 1.5 diopters, irregular astigmatism. |
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| Measure | Description | Time Frame |
|---|---|---|
| In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements | Corneal topography is a measurement of the shape of the anterior cornea. The shape of a cornea can be fully quantified by providing a map of local power. "Diopter" is the unit of refractive power of a lens. In case of the cornea, the power K [diopter] is related to the radius (curvature) R [mm] of the best fitting sphere by the relation K=337.5/R. Here, corneal topography measurements are implemented by the Placido method, i.e. by analyzing the reflection image of a ring-shaped illumination. According to International Standards Organization (ISO) 19980-2012, repeatability of corneal topography is assessed on the central cornea: area with diameter d<=3mm, and middle cornea: 3mm\ | 1 day of examination |
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences for One Measurement Per Device. | For definition of corneal topography, corneal power in "diopter", areas of evaluation and methods, see outcome 1. This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices. "power difference (2 devices)" is the sample mean and 95% C.I. of differences of spatial mean of corneal power between two devices. This value quantifies systematic differences between devices (e.g. calibration), ignoring local variations of the power measurement. "power difference (2 std.dev.)" is the sample mean of twice the standard deviation of local power differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Std. Dev. of Local Corneal Elevation Differences for One Measurement Per Device. | For definition of corneal topography, areas of evaluation and methods, see outcome 1 and 2. Corneal elevation refers to the distance between the measured corneal surface and the best fitting sphere, and is given in µm. This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices. "elevation difference (2 std. dev.)" is the sample mean of twice the standard deviation of local corneal elevation differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices. |
Inclusion Criteria:
Exclusion Criteria:
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Volunteers recruited at University Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Beatrice Frueh, Prof. Fr. | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Inselspital | Bern | 3010 | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Eye | Astigmatism smaller than 1.5 diopters |
| FG001 | Large Regular Astigmatism | Astigmatism of > 1.5 diopters, regular astigmatism. |
| FG002 | Large Irregular Astigmatism | Astigmatism of > 1.5 diopters, irregular astigmatism. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Eye | Astigmatism smaller than 1.5 diopters |
| BG001 | Large Regular Astigmatism | Astigmatism of > 1.5 diopters, regular astigmatism. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements | Corneal topography is a measurement of the shape of the anterior cornea. The shape of a cornea can be fully quantified by providing a map of local power. "Diopter" is the unit of refractive power of a lens. In case of the cornea, the power K [diopter] is related to the radius (curvature) R [mm] of the best fitting sphere by the relation K=337.5/R. Here, corneal topography measurements are implemented by the Placido method, i.e. by analyzing the reflection image of a ring-shaped illumination. According to International Standards Organization (ISO) 19980-2012, repeatability of corneal topography is assessed on the central cornea: area with diameter d<=3mm, and middle cornea: 3mm\ | Posted | Mean | 95% Confidence Interval | diopters | 1 day of examination |
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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 | Normal Eye | Astigmatism smaller than 1.5 diopters |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lucio Robledo, Clinical Trials Biometry | Haag Streit AG | +41 31 978 01 11 | 209 | lucio.robledo@haag-streit.com |
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| 1 day of examination |
| 1 day of examination |
| Equivalence of Keratometry Radius Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Radius Measurement Between Both Devices. | Keratometry radius refers to the corneal curvature R (see primary measure outcome). In this context, the cornea is approximated by a toric surface which can be characterized by a flat meridian (radius R1) and a steep meridian (radius R2) with an angle of 90 degrees between these meridians. This outcome measure aims at testing the equivalence of keratometry radius measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices. Reported are: population mean of difference and 95% confidence interval of mean difference for radius of flat meridian (R1) and radius of steep meridian (R2). | 1 day of examination |
| Equivalence of Keratometry Axis Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Axis Measurement Between Both Devices. | Keratometry axis refers to the axis of the flat meridian of the toric representation of the cornea. For additional information see outcome 4. This outcome measure aims at testing the equivalence of keratometry axis measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices. Reported are: population mean of difference and 95% confidence interval of mean difference for axis of flat meridian. | 1 day of examination |
| BG002 | Large Irregular Astigmatism | Astigmatism of > 1.5 diopters, irregular astigmatism. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| ID | Title | Description |
|---|
| OG000 | Normal Eye | Astigmatism smaller than 1.5 diopters |
| OG001 | Large Regular Astigmatism | Astigmatism of > 1.5 diopters, regular astigmatism. |
| OG002 | Large Irregular Astigmatism | Astigmatism of > 1.5 diopters, irregular astigmatism. |
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| Secondary | Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences for One Measurement Per Device. | For definition of corneal topography, corneal power in "diopter", areas of evaluation and methods, see outcome 1. This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices. "power difference (2 devices)" is the sample mean and 95% C.I. of differences of spatial mean of corneal power between two devices. This value quantifies systematic differences between devices (e.g. calibration), ignoring local variations of the power measurement. "power difference (2 std.dev.)" is the sample mean of twice the standard deviation of local power differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices. | Posted | Mean | 95% Confidence Interval | diopters | 1 day of examination |
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| Other Pre-specified | Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Std. Dev. of Local Corneal Elevation Differences for One Measurement Per Device. | For definition of corneal topography, areas of evaluation and methods, see outcome 1 and 2. Corneal elevation refers to the distance between the measured corneal surface and the best fitting sphere, and is given in µm. This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices. "elevation difference (2 std. dev.)" is the sample mean of twice the standard deviation of local corneal elevation differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices. | Posted | Mean | 95% Confidence Interval | micrometer | 1 day of examination |
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| Other Pre-specified | Equivalence of Keratometry Radius Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Radius Measurement Between Both Devices. | Keratometry radius refers to the corneal curvature R (see primary measure outcome). In this context, the cornea is approximated by a toric surface which can be characterized by a flat meridian (radius R1) and a steep meridian (radius R2) with an angle of 90 degrees between these meridians. This outcome measure aims at testing the equivalence of keratometry radius measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices. Reported are: population mean of difference and 95% confidence interval of mean difference for radius of flat meridian (R1) and radius of steep meridian (R2). | Posted | Mean | 95% Confidence Interval | micrometer | 1 day of examination |
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| Other Pre-specified | Equivalence of Keratometry Axis Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Axis Measurement Between Both Devices. | Keratometry axis refers to the axis of the flat meridian of the toric representation of the cornea. For additional information see outcome 4. This outcome measure aims at testing the equivalence of keratometry axis measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices. Reported are: population mean of difference and 95% confidence interval of mean difference for axis of flat meridian. | Posted | Mean | 95% Confidence Interval | degree | 1 day of examination |
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| Post-Hoc | Equivalence of Keratometry Axis Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Normalized Differences of Keratometry Axis Measurement Between Both Devices. | For definition of keratometry axis see outcome measures 4 and 5. This outcome measure aims at testing the equivalence of keratometry axis measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices. Reported are: population mean of normalized difference and 95% confidence interval of mean normalized difference for axis of flat meridian. Difference is normalized for each eye as function of astigmatism to a refractive error of 0.167 diopters (i.e. an axis difference of 1 normalized degree results in a refractive error of 0.167 diopter), to provide a measure which can be directly related to its impact on visual quality. Please note that for this analysis a separation in arms "normal eye" and "large regular astigmatism" is not meaningful, thus here both groups are analyzed jointly as group "regular eye" | Posted | Mean | 95% Confidence Interval | normalized degree | 1 day of examination |
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| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Large Regular Astigmatism | Astigmatism of > 1.5 diopters, regular astigmatism. | 0 | 8 | 0 | 8 |
| EG002 | Large Irregular Astigmatism | Astigmatism of > 1.5 diopters, irregular astigmatism. | 0 | 8 | 0 | 8 |
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require an extension of the embargo for 90 days. If the communication contains confidential information of the sponsor, the sponsor can require to replace this information by scientifically meaningful equivalent information.
| power difference (2 std.dev.), central cornea |
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| power difference (2 devices), middle cornea |
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| power difference (2 std.dev.), middle cornea |
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| elevation difference (2 std. dev.), middle cornea |
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| difference of steep meridian (R2) |
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