Repeatability in Measurements of Two ssOCT and One OLCR Biometer

Study Overview
=================
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.

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

Conditions
-----------------
Cataract Senile

Intervention / Treatment
-----------------
* Device: biometric measurement IOLMaster 700
* Device: biometric measurement Lenstar LS 700
* Device: biometric measurement Anterion Heildelberg


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biometric measurement repeatability<br>Biometric measurements will be performed in all patients | Device: biometric measurement IOLMaster 700<br>* Three biometric measurements will be performed with 3 devices for all the patients included<br>Device: biometric measurement Lenstar LS 700<br>* Three biometric measurements will be performed with 3 devices for all the patients included<br>Device: biometric measurement Anterion Heildelberg<br>* Three biometric measurements will be performed with 3 devices for all the patients included<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ss-OCT, OLCR, biometry