Level of Agreement of Intraocular Lens Power Measurements... | NCT03876782

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

NCT03876782

Sponsor

Democritus University of Thrace

Status

Completed

Last Update Posted

Mar 15, 2019Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Cataract

Interventions

IOLMaster
Verion

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2017Actual

Primary Completion Date

Dec 15, 2018Actual

Completion Date

Dec 15, 2018Actual

First Submitted Date

Mar 12, 2019

First Submission Date that Met QC Criteria

Mar 14, 2019

First Posted Date

Mar 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2019

Last Update Posted Date

Mar 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Georgios Labiris, Associate Professor of Ophthalmology, Democritus University of ThracePrincipal Investigator

Lead Sponsor

Democritus University of ThraceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IOLMaster group		IOL power for all cataract participants will be measured with IOLMaster and Verion	Diagnostic Test: IOLMaster Diagnostic Test: Verion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IOLMaster	Diagnostic Test	IOL power calculation will be done with IOLMaster	IOLMaster group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Senile Cataract

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georgios Labiris, MD, PhD	Associate Professor	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Alexandroupolis		Alexandroupoli	Evros	68100	Greece

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases