IOLMASTER 700 Central Topography Workflow Study.

Completed

• Conditions: Cataract
• Interventions: Device: IOLMaster 700 with central topography; Device: IOLMaster 700 without central topography plus Cassini; Device: IOLMaster 700 without central topography plus Pentacam

• Registration Number: NCT04875247
• Lead Sponsor: OFTALVIST (Oftalmología Vistahermosa S.L)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-06
• Study Start: 2021-05-12
• Primary Completion: 2021-09-09
• Study Completion: 2021-09-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm	IOLMaster 700 without central topography plus Cassini	All patients will be assigned to this cohort.
Single arm	IOLMaster 700 without central topography plus Pentacam	All patients will be assigned to this cohort.
Single arm	IOLMaster 700 with central topography	All patients will be assigned to this cohort.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Central topography	1 day (Cataract pre-surgery visit)	Measurement of keratometry (K): Flat Keratometry (K1) and Steep Keratometry (K2)

Trial Locations

Locations (1)

OFTALVIST (Oftalmología Vistahermosa S.L.); 🇪🇸 Jeréz de la Frontera, Cádiz, Spain