Zeiss® IOLMaster 700 Corneal Topography Module Comparison With Schwind's Sirius Corneal Topography® (VIMECT)

In order to determine the intraocular lens to be implanted during cataract surgery, keratometry and axial length must be measured in preoperative. The axial length is obtained by ocular ultrasound mode B. Keratometry is obtained by means of an automatic refractometer or corneal topography. Currently, ultrasound scanners are being developed with a topography module to combine axial length and keratometry measurement. The investigators want to evaluate the corneal topography module of the Zeiss® IOL Master 700 biometer.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract
• Intervention / Treatment: Other: measurement of axial length and keratometry by sonographers with a topographic module

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and Women Requiring CHV Cataract Surgery
• Aged 18 or over
• Insured under a social security scheme
• Having been informed of the clinical study and having given oral express consent

Exclusion Criteria:

• Person unable to express consent
• Patient with a history of corneal dystrophy, corneal refractive surgery or keratoconus.
• History of chronic corneal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corneal Topography with IOLMaster and Sirius topography.; The experimental group will have the two exams: the topography with the IOLMAster and the topography with Sirius topography.	Other: measurement of axial length and keratometry by sonographers with a topographic module; measurement of axial length and keratometry by sonographers with a topographic module

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
keratometry measurements	to show that the keratometry measurements obtained using the topography module integrated in the IOL Master 700 are consistent with those obtained by a standard topography in patients operated for cataract surgery. The measures will be: K1 (steepest corneal meridian), K2 (flattest corneal meridian), Kmax (central corneal keratometry), the unit of measurement is the diopter.	day 1

Collaborators and Investigators

• Sponsor: Edouard KOCH

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): January 30, 2024

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: P21/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No