IOLMASTER 700 Central Topography Workflow Study.

Cataract Clinical Trial

Official title:

IOLMASTER 700 Central Topography Workflow Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875247
• Other study ID #: IOLWORK
• Status: Completed
• Start date: May 12, 2021
• Est. completion date: September 9, 2021

Study information

• Verified date: February 2023
• Source: OFTALVIST (Oftalmología Vistahermosa S.L)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 9, 2021
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
Spain	OFTALVIST (Oftalmología Vistahermosa S.L.)	Jeréz de la Frontera	Cádiz

Sponsors (1)

Lead Sponsor	Collaborator
OFTALVIST (Oftalmología Vistahermosa S.L)

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Ruiz-Mesa R, Ruiz-Santos M, Blanch-Ruiz J, Jimenez-Nieto A. Acquisition Time for Swept-Source Optical Biometry Plus Corneal Power Measurement During Cataract Evaluation. Clin Ophthalmol. 2022 Mar 5;16:661-668. doi: 10.2147/OPTH.S351845. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time needed to do the measurements with each equipment	Time needed to do the measurements with each equipment	1 day (Cataract pre-surgery visit)
Secondary	Central topography	Measurement of keratometry (K): Flat Keratometry (K1) and Steep Keratometry (K2)	1 day (Cataract pre-surgery visit)