Comparison Between Two Ss-OCT Biometry

• Sponsor: Vienna Institute for Research in Ocular Surgery (Other)
• Overall Status: Completed
• CT.gov ID: NCT04333056
• Collaborator: (none)
• Enrollment: 210
• Location: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 71

Study Details

Study Description

Brief Summary

Since recently a second swept-source optical coherence tomography (ss-OCT) optical biometry device was launched (Anterion, Heidelberg Engineering). Aim of this study is a retrospective data collection of patients who were measured with both ss-OCT optical biometry devices and to assess the limits of agreement of the two devices.

Retrospective comparison of two ss-OCT biometry devices concerning comparability of measurements of axial eye length, anterior chamber depth, lens thickness and keratometry.

Condition or Disease	Intervention/Treatment	Phase
Cataract Senile	Other: Biometric measurement agreement

Detailed Description

This a retrospective study including data acquired from patients that attended pre-surgical examination as it is the standard in the investigator's hospital.

The IOL Master 700 (Carl Zeiss Meditec AG, Jena) and the Heidelberg Anterion (Heidelberg Engineering, Germany) are biometry devices that use swept-source optical coherence tomography technology in combination with a multidot-keratometer, that obtain two-dimensional images of ocular structures.

The difference between the two devices resides in the wavelength of the infrared laser:

1200-1400nm for the Anterion and 1050nm for the IOL Master 700.

The SS-OCT devices provide a scan depth of 44mm and a resolution in tissue of 22 μm for the IOL Master 700 and of 14x16.5 mm and 30 μm for the Heidelberg Anterion.

Study Design

• Study Type: Observational
• Actual Enrollment: 210 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Comparison of Two Swept-Source Optical Coherence Tomography-based Biometry Devices
• Actual Study Start Date: May 14, 2019
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Aug 12, 2019

Outcome Measures

Primary Outcome Measures

1. Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters AL, ACD, LT (evaluated in mm) [6 months]

   For descriptive analysis, Kolmogorov Smirnov test will be used to evaluate normal distribution. The student T test for paired samples and Wilcoxon for nonparametric data was used to compare parameters as: AL, ACD, LT. The limits of agreement (1.96xSD) between two optical biometers were calculated and represented graphically using Bland-Altman graphs

2. Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters CCT (evaluated in micrometer) [6 months]

   For descriptive analysis, Kolmogorov Smirnov test will be used to evaluate normal distribution. The student T test for paired samples and Wilcoxon for nonparametric data was used to compare the CCT data The limits of agreement (1.96xSD) between two optical biometers were calculated and represented graphically using Bland-Altman graphs

3. Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameter: keratometry (evaluated in diopter) [6 months]

   For descriptive analysis, Kolmogorov Smirnov test will be used to evaluate normal distribution. The student T test for paired samples and Wilcoxon for nonparametric data was used to compare keratometry data The limits of agreement (1.96xSD) between two optical biometers were calculated and represented graphically using Bland-Altman graphs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age-related cataract

Exclusion Criteria:

• nystagmus

• physical inabilities that could interfere with fixation

• dens cataract

• macular or corneal pathologies that could compromise fixation during the measurements.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vienna Institute for Research in Ocular Surgery (VIROS)	Vienna		Austria	1140

Sponsors and Collaborators

• Vienna Institute for Research in Ocular Surgery

Investigators

• Principal Investigator: Oliver Findl, Prof., MD, VIROS, Hanusch Hospital Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Head of Ophthalmology Department, principal investigator, Vienna Institute for Research in Ocular Surgery
• ClinicalTrials.gov Identifier: NCT04333056
• Other Study ID Numbers: ss-OCT biometry comparison
• First Posted: Apr 3, 2020
• Last Update Posted: Apr 3, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Head of Ophthalmology Department, principal investigator, Vienna Institute for Research in Ocular Surgery: biometry; ss-OCT; cataract
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Apr 3, 2020