Repeatability in Measurements of Two ssOCT and One OLCR Biometer

Prim. Prof. Dr. Oliver Findl, MBA

Status: Completed

Conditions: Cataract Senile

Treatments: Device: biometric measurement Anterion Heildelberg; Device: biometric measurement IOLMaster 700; Device: biometric measurement Lenstar LS 700

Study type: Interventional

Funder types: Other

Identifiers

NCT04255706

ANT

Details and patient eligibility

About

Achieving high accuracy and precision in ocular biometry has become primordial for cataract surgery, due to the shift of cataract surgery from a rehabilitation procedure to a refractive one.

Aim of this study is to determine the repeatability of ocular biometric parameters obtained using three biometry devices, two ss-OCT biometers and an OLCR device.

Full 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.

This a prospective observational study that would include 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, Lenstar LS 700 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.

Enrollment: 50 patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 40 years old or above
• age-related cataract

Exclusion criteria

• patients with dense cataract or 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Biometric measurement repeatability

Other group

Description:

Biometric measurements will be performed in all patients

Treatment:

Device: biometric measurement Anterion Heildelberg

Device: biometric measurement Lenstar LS 700

Device: biometric measurement IOLMaster 700