IOLMASTER 700 Central Topography Workflow Study.

February 15, 2023 updated by: OFTALVIST (Oftalmología Vistahermosa S.L)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cádiz
      • Jeréz de la Frontera, Cádiz, Spain, 11407
        • OFTALVIST (Oftalmología Vistahermosa S.L.)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients older than 50 years with cataracts that have to undergo a cataracts surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time needed to do the measurements with each equipment
Time Frame: 1 day (Cataract pre-surgery visit)
Time needed to do the measurements with each equipment
1 day (Cataract pre-surgery visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central topography
Time Frame: 1 day (Cataract pre-surgery visit)
Measurement of keratometry (K): Flat Keratometry (K1) and Steep Keratometry (K2)
1 day (Cataract pre-surgery visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OFTALVIST (Oftalmología Vistahermosa S.L)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Actual)

September 9, 2021

Study Completion (Actual)

September 9, 2021

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOLWORK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on IOLMaster 700 with central topography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe