Comparison Between Two Ss-OCT Biometry

NCT04333056 | Completed

• 1 other identifier: ss-OCT biometry comparison
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Senile

Keywords

biometry; ss-OCT; cataract

Outcome Measures

Primary Outcomes (3)

• Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters AL, ACD, LT (evaluated in mm)

  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

  6 months

• Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters CCT (evaluated in micrometer)

  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

  6 months

• Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameter: keratometry (evaluated in diopter)

  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

  6 months

Interventions

Biometric measurement agreement OTHER

Patients scheduled for cataract surgery were measured with both ss-OCT devices. The following biometry parameters were compared: anterior keratometry, central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT) and axial length (AL).

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The participants were selected by the clinical investigators at the Hanusch Hospital.

You may qualify if:

• age-related cataract

You may not qualify if:

• nystagmus
• physical inabilities that could interfere with fixation
• dens cataract
• macular or corneal pathologies that could compromise fixation during the measurements.

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

Location

Related Publications (1)

• Fisus AD, Hirnschall ND, Findl O. Comparison of 2 swept-source optical coherence tomography-based biometry devices. J Cataract Refract Surg. 2021 Jan 1;47(1):87-92. doi: 10.1097/j.jcrs.0000000000000373.

  PMID: 32769752 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Oliver Findl, Prof., MD

  VIROS, Hanusch Hospital Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology Department, principal investigator

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: April 3, 2020
• Study Start: May 14, 2019
• Primary Completion: July 31, 2019
• Study Completion: August 12, 2019
• Last Updated: April 3, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)