Repeatability in Measurements of Two ssOCT and One OLCR Biometer

Cataract Senile Clinical Trial

Official title:

Evaluation of Repeatability in Measurements of Two Swept-source Optical Coherence Tomography (Ss-OCT) Biometers and One Optical Low Coherence Reflectometry (OLCR) Biometer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255706
• Other study ID #: ANT
• Status: Completed
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: September 2020
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Intervention

Device:
• biometric measurement IOLMaster 700
Three biometric measurements will be performed with 3 devices for all the patients included
• biometric measurement Lenstar LS 700
Three biometric measurements will be performed with 3 devices for all the patients included
• biometric measurement Anterion Heildelberg
Three biometric measurements will be performed with 3 devices for all the patients included

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery (VIROS)	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Prim. Prof. Dr. Oliver Findl, MBA

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of repeatability between two ss-OCT and one OLCR biometry device	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)	8 months