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Clinical trial

Influence of Artificial Tears on Corneal Parameter Measurement Using Three Different Devices: Scheimpflug-, Keratometry - and Placido-technology

ID
Name
20-928
Description
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: * Do artificial tears alter the measurements of the corneal surface * Is there a difference between the devices used in this study This is relevant because high quality measurements improve the postoperative outcome after cataract surgery.
Trial arms
Trial start
2020-11-20
Estimated PCD
2022-04-22
Trial end
2022-04-22
Status
Completed
Treatment
Artificial tear
Application of low viscosity artificial tears (Artelac EDO). The active ingredient is hypromellose (1.92 mg per 0.6 ml container).
Arms:
Galilei G6, IOL Master 700, Pentacam AXL
Other names:
Artelac EDO
No artificial tears
Before artificial tear application, 2 baseline measurements were taken of the cornea without any intervention
Arms:
Galilei G6, IOL Master 700, Pentacam AXL
Size
145
Primary endpoint
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)
Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
Eligibility criteria
Inclusion Criteria: * Healthy eyes Exclusion Criteria: * Any prior intraocular surgery or trauma * Any corneal pathology (ABMD, Fuch's, etc.) * Active ocular pathology (e.g., amblyopia, ARMD) * Contact lens wear within 2 weeks of study * Any corneal relaxing incisions or astigmatic keratotomy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'one arm for each diagnostic device (three in total)', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The investigator and patient knew which device they were tested on'}}, 'enrollmentInfo': {'count': 145, 'type': 'ACTUAL'}}
Updated at
2024-04-10

1 organization

1 product

1 indication

Organization
University Clinic Frankfurt
Product
Artificial tear
Indication
Healthy