NCT04196621

Clinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 40 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cataract
• Dry Eye

Interventions

Type	Name	Description
DEVICE	High viscous artificial tears	Instillation of one drop high viscous artificial tears
DEVICE	Low viscous artificial tears	Instillation of one drop low viscous artificial tears

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-12-31
• Completion: 2020-02-15
• First posted: 2019-12-12
• Last updated: 2020-04-29

Locations

1 site across 1 country: Austria