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The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:
This is relevant because high quality measurements improve the postoperative outcome after cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOL Master 700 | Active Comparator | Patients in this arm are measured twice with the IOL master 700 without intervention. After this artificial tears are applied and followed by 4 more measurements |
|
| Pentacam AXL | Active Comparator | Patients in this arm are measured twice with the Pentacam AXL without intervention. After this artificial tears are applied and followed by 4 more measurements |
|
| Galilei G6 | Active Comparator | Patients in this arm are measured twice with the Galilei G6 without intervention. After this artificial tears are applied and followed by 4 more measurements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial tear | Drug | Application of low viscosity artificial tears (Artelac EDO). The active ingredient is hypromellose (1.92 mg per 0.6 ml container). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) | Difference of measurement of the mean corneal refractive power in diopters before artificial tear application and after artificial tear application using one of three devices (IOL Master 700, Pentacam AXL or Galilei G6) | Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application |
| Measure | Description | Time Frame |
|---|---|---|
| Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application? | Difference of measurement of the mean corneal refractive power in diopters before artificial tear (Artelac EDO) application and after artificial tear application between the three devices (IOL Master 700 using Keratometry, Pentacam AXL and Galilei G6 using Schmeipflug technology) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goethe University Hospital | Frankfurt am Main | Hesse | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32828877 | Background | Roggla V, Leydolt C, Schartmuller D, Schwarzenbacher L, Meyer E, Abela-Formanek C, Menapace R. Influence of Artificial Tears on Keratometric Measurements in Cataract Patients. Am J Ophthalmol. 2021 Jan;221:1-8. doi: 10.1016/j.ajo.2020.08.024. Epub 2020 Aug 21. |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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one arm for each diagnostic device (three in total)
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The investigator and patient knew which device they were tested on
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|
| No artificial tears | Other | Before artificial tear application, 2 baseline measurements were taken of the cornea without any intervention |
|
| Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application |
| Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) | Difference of measurement of the mean corneal astigmatism in diopters before artificial tear (Artelac EDO) application and after artificial tear application using three different devices (IOL Master 700, Pentacam AXL and Galilei G6) | Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application |
| If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)? | How long does the difference of mean corneal refractive power in diopters before artificial tear (artelac ego) application and after artificial tear application last | Comparison between the baseline measurements and the measurements up to 10 minutes after artificial tear applications |
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |