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

NCT ID: NCT03876782

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-15

Study Completion Date

2018-12-15

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IOLMaster group

IOL power for all cataract participants will be measured with IOLMaster and Verion

IOLMaster

Intervention Type DIAGNOSTIC_TEST

IOL power calculation will be done with IOLMaster

Verion

Intervention Type DIAGNOSTIC_TEST

IOL power calculation will be done with Verion

Interventions

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IOLMaster

IOL power calculation will be done with IOLMaster

Intervention Type DIAGNOSTIC_TEST

Verion

IOL power calculation will be done with Verion

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Senile Cataract

Exclusion Criteria

* Former incisional surgery,
* Corneal diseases,
* Dry-eye-Disease,
* Glaucoma drops,
* Inability to obtain accurate measurements.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Democritus University of Thrace

OTHER

Sponsor Role lead

Responsible Party

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Georgios Labiris

Associate Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios Labiris, MD, PhD

Role: STUDY_CHAIR

Associate Professor

Locations

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University Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

Site Status

Countries

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Greece

Other Identifiers

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Th9/ES2/22-2-19

Identifier Type: -

Identifier Source: org_study_id

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