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

NCT ID: NCT05232214

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-10-01

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.

Detailed Description

Accurate and repeatable biometric measurements are essential in providing an optimal refractive outcome.

ss-OCT biometry uses a tunable wavelength laser source to scan the eye, this technology showing its superiority through better signal-to-noise ratio, the wavelength light source being projected into the eye, one at a time; thus improving tissue penetration.

A previous study reported that the AL differs between adults was due mainly to the difference in vitreous cavity. The longer the AL becomes, the longer the posterior vitreous body becomes and the Argos defines the vitreous refractive index as 1.336. Therefore it is possible that the equivalent refractive index used in the IOLMaster 700 exceeds 1.336. Omoto et al. showed that the comparison of the arithmetic prediction errors between the Argos and IOLMaster 700 indicated that both biometers showed a myopic trend and the median arithmetic prediction errors were closer to zero with the Argos, the longer the AL became, this trend became more marked, suggesting that the Argos showed a significant hyperopic trend, especially with longer ALs.

This might show the advantage of using segmental refractive index instead of equivalent refractive index in longer ALs. Nevertheless, the authors did not include short eyes (<22mm) and longer AL (>32mm), thus further studies should be needed.

The aim of the study is to compare the agreement and repeatability of AL measurement using three different ssOCT devices in short (<22.5mm) and long eyes (>25.5mm).

This a prospective, randomised, observational study that would include patients (42 eyes of 42 patients) which attended pre-surgical examination. A written informed consent will be obtained from each patient.

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 and between the measurements they will be asked to blink or keep their eyes closed for tear film recovery and to avoid fatigue. Scans that pass the quality requirement of each device will be taken for analysis.

The order in which the measurements will be performed (Anterion, IOLMaster 700 or Argos) will be randomised using randomised.org.

Patients will be measured 8 weeks (+/-2 weeks) postoperatively with the three devices and the postoperative examination will also contain visual acuity, autorefraction and subjective refraction.

Each patient will receive the same type of lens (standard IOL, Clareon, Alcon). Inclusion criteria

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

• Main outcome: Limits of agreement (1.96xSD) between the optical biometers for the AL (mm) data

• Secondary outcomes:
• Subgroup analysis for the refractive outcome (SEQ) after 8 weeks (+/-2 weeks) in short (<22,5mm) and long eyes (>25,5mm).
• Limits of agreement (1.96xSD) between the optical biometers for the following variables: keratometry (Ks, Kf, Km), CCT (µm), ACD (mm), LT (mm),
• Duration (seconds) of measurement time and total time (including data entry)
• Evaluation of the Barrett (and Haigis formulae with the 3 devices (mean of actual vs. mean of predicted SEQ)
• Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation between the three devices

Conditions

Cataract

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

short eyes

Axial length under 22.5 mm

Biometry

Intervention Type: 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

Axial length under 25.5 mm

Biometry

Intervention Type: 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

Interventions

Biometry

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Prof. Dr, Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hanusch Hospital, Department of Ophthalmology

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Oliver Findl, Prof. MD

Role: primary

office@viros.at

+43 1 91021 57564

Other Identifiers

Argos

Identifier Type: -

Identifier Source: org_study_id