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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05414773
Other study ID # P21/19
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date January 30, 2024

Study information

Verified date August 2022
Source Versailles Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date January 30, 2024
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Edouard KOCH

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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