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

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ClinicalTrials.gov Identifier: NCT03876782
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Georgios Labiris, Democritus University of Thrace

Brief Summary:
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.

Condition or disease Intervention/treatment
Cataract Diagnostic Test: IOLMaster Diagnostic Test: Verion

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).

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Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Level of Agreement of Intraocular Lens Power Measurements Between IOLMaster and Verion
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : December 15, 2018
Actual Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




Primary Outcome Measures :
  1. IOL Power Calculation [ Time Frame: 1 day prior to surgery ]
    Exact calculation of dioptric power of the intraocular lens



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cataract patient that visit the Cataract Outpatients Service of the University Hospital of Alecxnadroupolis
Criteria

Inclusion Criteria:

  • Senile Cataract

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876782


Locations
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Greece
University Hospital of Alexandroupolis
Alexandroupolis, Evros, Greece, 68100
Sponsors and Collaborators
Democritus University of Thrace
Investigators
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Study Chair: Georgios Labiris, MD, PhD Associate Professor

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Responsible Party: Georgios Labiris, Associate Professor of Ophthalmology, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT03876782     History of Changes
Other Study ID Numbers: Th9/ES2/22-2-19
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Georgios Labiris, Democritus University of Thrace:
cataract surgery
Verion Image-Guided System
IOLMaster
IOL calculation
keratometry
corneal power
toric IOL

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases