NCT04875247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

May 12, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2021

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

May 3, 2021

Last Update Submit

February 15, 2023

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Central topography

    1 day (Cataract pre-surgery visit)

Study Arms (1)

Single arm

All patients will be assigned to this cohort.

Device: IOLMaster 700 with central topographyDevice: IOLMaster 700 without central topography plus CassiniDevice: IOLMaster 700 without central topography plus Pentacam

Interventions

IOLMaster 700 with central topographyDEVICE

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

Single arm
IOLMaster 700 without central topography plus CassiniDEVICE

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

Single arm
IOLMaster 700 without central topography plus PentacamDEVICE

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

Single arm

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients that have to undergo a cataract surgery
  • Patients older than 50 years.

You may not qualify if:

  • Patients that have already undergone a previous corneal surgery.
  • Patients suffering from keratoconus.
  • Patients exhibiting corneal scars
  • Patients exhibiting pterygium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OFTALVIST (Oftalmología Vistahermosa S.L.)

Jeréz de La Frontera, Cádiz, 11407, Spain

Location

Related 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.

    PMID: 35282169RESULT

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Ramón Ruiz Mesa., Doctor

    OFTALVIST (Oftalmología Vistahermosa S.L)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 6, 2021

Study Start

May 12, 2021

Primary Completion

September 9, 2021

Study Completion

September 9, 2021

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

ES(1)