Level of Agreement of Intraocular Lens Power Measurements Between IOLMaster and Verion

March 14, 2019 updated by: Georgios Labiris, Democritus University of Thrace
Primary objective of this study is to evaluate the level of agreement of two keratometry modules, the IOLMaster and the Verion Reference Unit, in terms of keratometric values and IOL power calculation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants were enrolled from the Cataract & Presbyopia Service of the University General Hospital of Alexandroupolis in a consecutive-if-eligible basis. Apart from keratometric values, IOL power calculations will be compared for 8 IOL models (Acrysof SN60WF, SN60AT, SN6ATx, TFNT00, TFNTx0, SV25T0, SV25Tx and Tecnis ZCB00) using 4 formulas (SRK/T, Holladay 1, Hoffer Q and Haigis).

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • University Hospital of Alexandroupolis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cataract patient that visit the Cataract Outpatients Service of the University Hospital of Alecxnadroupolis

Description

Inclusion Criteria:

  • Senile Cataract

Exclusion Criteria:

  • Former incisional surgery,
  • Corneal diseases,
  • Dry-eye-Disease,
  • Glaucoma drops,
  • Inability to obtain accurate measurements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IOLMaster group
IOL power for all cataract participants will be measured with IOLMaster and Verion
Diagnostic test: IOLMaster
IOL power calculation will be done with IOLMaster
Diagnostic test: Verion
IOL power calculation will be done with Verion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOL Power Calculation
Time Frame: 1 day prior to surgery
Exact calculation of dioptric power of the intraocular lens
1 day prior to surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Actual)

December 15, 2018

Study Completion (Actual)

December 15, 2018

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Th9/ES2/22-2-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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