NCT03876782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 12, 2019

Last Update Submit

March 14, 2019

Conditions

Cataract

Keywords

cataract surgeryVerion Image-Guided SystemIOLMasterIOL calculationkeratometrycorneal powertoric IOL

Outcome Measures

Primary Outcomes (1)

  • IOL Power Calculation

    Exact calculation of dioptric power of the intraocular lens

    1 day prior to surgery

Study Arms (1)

IOLMaster group

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

Diagnostic Test: IOLMasterDiagnostic Test: Verion

Interventions

IOLMasterDIAGNOSTIC_TEST

IOL power calculation will be done with IOLMaster

IOLMaster group
VerionDIAGNOSTIC_TEST

IOL power calculation will be done with Verion

IOLMaster group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Senile Cataract

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Georgios Labiris, MD, PhD

    Associate Professor

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 15, 2019

Study Start

December 15, 2017

Primary Completion

December 15, 2018

Study Completion

December 15, 2018

Last Updated

March 15, 2019

Record last verified: 2019-03

Locations

GR(1)