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OpenTrials
Completed

NCT Number: NCT04196621

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

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.

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Key information

Conditions

Cataract Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Lens Diseases

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High viscous artificial tears

Device

Instillation of one drop high viscous artificial tears

Low viscous artificial tears

Device

Instillation of one drop low viscous artificial tears

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.

    Time frame: 30 seconds

    The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated

Secondary outcomes

  1. 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.

    Time frame: 2, 5minutes

    The change in measured k-values (k, k1, k2 in mm)before and after instillation of artificial eye drops will be calculated

  2. 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

    Time frame: 30 seconds, 2 minutes or 5 minutes

    The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated

  3. 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

    Time frame: 30 seconds, 2 minutes or 5 minutes

    The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Acronym: KerSty

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 12, 2019
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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