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The investigational device is an approved biometry device to perform biometric measurements preoperatively to calculate the needed IOL power.
First, two native measurements at the IOL Master will be performed. Thereafter randomly assigned artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.
At least 24hours after those measurements, two native measurements at the IOL Master will be performed. Thereafter, the not yet used artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.
Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry without and with artificial tear drops.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High viscous artificial tears | Active Comparator | First, a native measurement at the IOL Master will be performed. Following which, high viscous artificial tears are installed and the biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes |
|
| Low viscous artificial tears | Active Comparator | First, a native measurement at the IOL Master will be performed. Following which, low viscous artificial tears are installed and the biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High viscous artificial tears | Device | Instillation of one drop high viscous artificial tears |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to determine whether application of highly viscid eye drops in normal eyes leads to a change in keratometry measurements after 30 seconds. | The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated | 30 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether application of highly viscid eye drops in normal eyes leads to a change keratometry measurements after 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective. | The change in measured k-values (k, k1, k2 in mm)before and after instillation of artificial eye drops will be calculated | 2, 5minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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Biometry will be performed in individuals with age related cataract. Patients will be classified as dry eye or normal eye. Two different artificial tears will be instilled at two time points in a randomized order with a time-lag of at least 24 hours.
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Which eye as well as the order of artificial eye drops will be randomized. Randomization information will be put in a sealed envelope on screening date and opened in operating theatre right before procedure start.
| Low viscous artificial tears | Device | Instillation of one drop low viscous artificial tears |
|
| To determine whether application of slightly viscid eye drops in normal and in dry eyes leads to a change in keratometry measurements after 30 seconds, 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective | The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated | 30 seconds, 2 minutes or 5 minutes |
| To determine whether application of highly viscid eye drops in dry eyes leads to a change in keratometry measurements after 30 seconds, 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective | The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated | 30 seconds, 2 minutes or 5 minutes |