Comparison of Three Swept-source Optical Coherence Biometry Devices in Long and Short Eyes

NCT05232214 | Unknown

• 1 other identifier: Argos
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the agreement and repeatability of ocular biometric parameters obtained using three swept-source optical coherence tomography (ss-OCT) device (Argos, IOLMaster 700 and ANTERION). This is a prospective, single centre study, that would include a number of 50 eyes of 50 patients, which attend pre-surgical examination. Three measurements per biometry device will be performed on the day of the first eye surgery. The measurements will be performed in a randomised fashion with three ss-OCT devices (IOLMaster 700, Argos and ANTERION). Inclusion criteria are: 40 years or above, age-related cataract, 20 eyes with AL\< 22.0 mm and 30 eyes with AL\>25.5 mm. Exclusion criteria are: patients with ocular or systemic pathologies that would interfere with the measurements (e.g. dense cataract, corneal pathology, nystagmus). The main outcome of the study will be: the difference (Limits of agreement) between the devices for the following parameters: keratometry (Ks, Kf, Km), CCT (µm), ACD (mm), LT (mm), AL (mm). Secondary outcomes will be: repeatability coefficient and coefficient of variation between the three device, measurement time for each device, and the feasibility for the Argos device.

Conditions

Cataract

Keywords

biometry

Outcome Measures

Primary Outcomes (1)

• Axial length

  Limits of agreement (1.96xSD) between the optical biometers for the AL (mm) data

  8Weeks

Secondary Outcomes (2)

• other Biometry parameter

  8 weeks

• Repeatability

  8 weeks

Study Arms (2)

short eyes

Axial length under 22.5 mm

Device: Biometry

long eyes

Axial length under 25.5 mm

Device: Biometry

Interventions

Biometry DEVICE

Only one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Argos and Anterion Heildelberg). Each patient will be measured three times with each device

long eyes; short eyes

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

age related cataract

You may qualify if:

• Written informed consent
• years old or above
• age-related cataract
• AL\<22.5 mm or \>25.5 mm (long or short eyes)

You may not qualify if:

• patients with dense cataract (LOCS grading III) or mature cataract
• corneal pathology that would significantly influence biometric measurements
• nystagmus or pathologies that would affect patient fixation
• pregnancy- for women in reproductive age a pregnancy test will be performed.

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Hanusch Hospital, Department of Ophthalmology

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Biometry

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr, Head of Department

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: February 9, 2022
• Study Start: January 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)