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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

Tracking Information
First Submitted Date March 12, 2019
First Posted Date March 15, 2019
Last Update Posted Date March 15, 2019
Actual Study Start Date December 15, 2017
Actual Primary Completion Date December 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2019)
IOL Power Calculation [ Time Frame: 1 day prior to surgery ]
Exact calculation of dioptric power of the intraocular lens
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Level of Agreement of Intraocular Lens Power Measurements Between IOLMaster and Verion
Official Title Level of Agreement of Intraocular Lens Power Measurements Between IOLMaster and Verion
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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Cataract patient that visit the Cataract Outpatients Service of the University Hospital of Alecxnadroupolis
Condition Cataract
Intervention
  • Diagnostic Test: IOLMaster
    IOL power calculation will be done with IOLMaster
  • Diagnostic Test: Verion
    IOL power calculation will be done with Verion
Study Groups/Cohorts IOLMaster group
IOL power for all cataract participants will be measured with IOLMaster and Verion
Interventions:
  • Diagnostic Test: IOLMaster
  • Diagnostic Test: Verion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 14, 2019)
54
Original Actual Enrollment Same as current
Actual Study Completion Date December 15, 2018
Actual Primary Completion Date December 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Senile Cataract

Exclusion Criteria:

  • Former incisional surgery,
  • Corneal diseases,
  • Dry-eye-Disease,
  • Glaucoma drops,
  • Inability to obtain accurate measurements.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT03876782
Other Study ID Numbers Th9/ES2/22-2-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Georgios Labiris, Democritus University of Thrace
Study Sponsor Democritus University of Thrace
Collaborators Not Provided
Investigators
Study Chair: Georgios Labiris, MD, PhD Associate Professor
PRS Account Democritus University of Thrace
Verification Date March 2019