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

Cataract Clinical Trial

— KerSty  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196621
• Other study ID #: 2112/2018
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 15, 2020

Study information

• Verified date: April 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 15, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

Inclusion Criteria:

• diagnosed uni- or bilateral age-related cataract

• Age 40 to 95

• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

• Corneal abnormality (Corneal scaring)

• usage of artificial tears/eyedrops 24h before the examination

• necessity of any topical therapy of the eye (i.e. glaucoma)

• active ocular or nasal allergies or corneal or conjunctival infection

• abnormality of the nasolacrimal drainage apparatus

• dry eye severity level 4 (severe and/or disabling constant discomfort and visual symptoms, marked conjunctival injection, filamentary keratitis, mucus clumping, tear debris, ulceration, trichiasis, keratinization, symblepharon)

• lid deformities

• Preceding ocular surgery or trauma

• Pregnancy

• Lactation

• Uncontrolled systemic or ocular disease

Related Conditions & MeSH terms

• Cataract
• Dry Eye

Intervention

Device:
• High viscous artificial tears
Instillation of one drop high viscous artificial tears
• Low viscous artificial tears
Instillation of one drop low viscous artificial tears

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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