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

NCT04196621 | Completed DMC

• 1 other identifier: 2112/2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  2, 5minutes

• 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

  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

  30 seconds, 2 minutes or 5 minutes

Study Arms (2)

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

Device: High viscous artificial tears

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

Device: Low viscous artificial tears

Interventions

High viscous artificial tears DEVICE

Instillation of one drop high viscous artificial tears

High viscous artificial tears

Low viscous artificial tears DEVICE

Instillation of one drop low viscous artificial tears

Low viscous artificial tears

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Cataract; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 12, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: February 15, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)