IOLMASTER 700 Central Topography Workflow Study.

Sponsor
OFTALVIST (Oftalmología Vistahermosa S.L) (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04875247
Collaborator
(none)
100
Enrollment
1
Location
7
Anticipated Duration (Months)
14.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The use of ocular biometers like IOLMaster 700, is a common practice to identify several ocular parameters such as the keratometry of the cornea and the axial length of the eye, which are necessary for calculating the power of the intraocular lens in cataract surgery. However, the additional use of other devices, such as Cassini and Pentacam is used to obtain more information of the central topography of the eye. Recently, a new version of the IOLMaster 700 equipment that provides much more detailed information than in its previous version has been presented. The objective of this study is to measure the time that the new IOLMaster 700 takes to perform these measurements of the central topography and compare it with the time it takes using the central topography using the standard IOLMaster 700 version with Cassini on one hand and Pentacam on the other.

It is hypothesized that the use of the new version of the IOLMaster 700 equipment alone can reduce the time of measurements and improve the clinic workflow.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: IOLMaster 700 with central topography
  • Device: IOLMaster 700 without central topography plus Cassini
  • Device: IOLMaster 700 without central topography plus Pentacam

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
IOLMASTER 700 Central Topography Workflow Study.
Actual Study Start Date :
May 12, 2021
Anticipated Primary Completion Date :
Dec 12, 2021
Anticipated Study Completion Date :
Dec 12, 2021

Arms and Interventions

ArmIntervention/Treatment
Single arm

All patients will be assigned to this cohort.

Device: IOLMaster 700 with central topography
The time needed to perform the measurement using the IOLMaster700 equipment with central topography will be recorded.

Device: IOLMaster 700 without central topography plus Cassini
The time needed to perform the measurement using the IOLMaster700 equipment without central topography plus the Cassini equipment will be recorded.

Device: IOLMaster 700 without central topography plus Pentacam
The time needed to perform the measurement using the IOLMaster700 equipment without central topography plus the Pentacam equipment will be recorded.

Outcome Measures

Primary Outcome Measures

  1. Time needed to do the measurements with each equipment [1 day (Cataract pre-surgery visit)]

    Time needed to do the measurements with each equipment

Secondary Outcome Measures

  1. Central topography [1 day (Cataract pre-surgery visit)]

    Measurement of keratometry (K): Flat Keratometry (K1) and Steep Keratometry (K2)

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients that have to undergo a cataract surgery

  • Patients older than 50 years.

Exclusion Criteria:
  • Patients that have already undergone a previous corneal surgery.

  • Patients suffering from keratoconus.

  • Patients exhibiting corneal scars

  • Patients exhibiting pterygium

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1OFTALVIST (Oftalmología Vistahermosa S.L.)Jeréz de la FronteraCádizSpain11407

Sponsors and Collaborators

  • OFTALVIST (Oftalmología Vistahermosa S.L)

Investigators

  • Principal Investigator: Ramón Ruiz Mesa., Doctor, OFTALVIST (Oftalmología Vistahermosa S.L)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
OFTALVIST (Oftalmología Vistahermosa S.L)
ClinicalTrials.gov Identifier:
NCT04875247
Other Study ID Numbers:
  • IOLWORK
First Posted:
May 6, 2021
Last Update Posted:
Oct 4, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2021