NCT05414773

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

June 3, 2022

Last Update Submit

August 22, 2022

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Corneal Topography with IOLMaster and Sirius topography.

EXPERIMENTAL

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

Interventions

measurement of axial length and keratometry by sonographers with a topographic moduleOTHER

measurement of axial length and keratometry by sonographers with a topographic module

Corneal Topography with IOLMaster and Sirius topography.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator Coordinator

Study Record Dates

First Submitted

June 3, 2022

First Posted

June 10, 2022

Study Start

September 1, 2022

Primary Completion

July 1, 2023

Study Completion

January 30, 2024

Last Updated

August 24, 2022

Record last verified: 2022-08