Repeatability in Measurements of Two ssOCT and One OLCR Biometer

Not Applicable

Completed

• Conditions: Cataract Senile
• Interventions: Device: biometric measurement IOLMaster 700; Device: biometric measurement Lenstar LS 700; Device: biometric measurement Anterion Heildelberg

• Registration Number: NCT04255706
• Lead Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Brief Summary

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.

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.

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.

Study Timeline

• Study Start: 2019-11-25
• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-05
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biometric measurement repeatability	biometric measurement IOLMaster 700	Biometric measurements will be performed in all patients
Biometric measurement repeatability	biometric measurement Lenstar LS 700	Biometric measurements will be performed in all patients
Biometric measurement repeatability	biometric measurement Anterion Heildelberg	Biometric measurements will be performed in all patients

Primary Outcome Measures

Name	Time	Method
Evaluation of repeatability between two ss-OCT and one OLCR biometry device	8 months	Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation between two ss-OCT and the OLCR biometry device will be calculated for all the parameters (axial length, keratometry, anterior chamber depth, lens thickness)

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery (VIROS); 🇦🇹 Vienna, Austria