A Comparison of Two Devices for Taking Measurements of the Eye to Assist in Lens Selection for Cataract Surgery

Study Overview
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Brief Summary
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The purpose of this study is to compare the Ziemer Ophthalmic Systems AG GALILEI G6 Lens Professional to the Oculus Pentacam® AXL for taking images and measurements of the anterior segment of the eye, including the cornea, pupil, anterior chamber and lens, to assist in determining the power of the intraocular lens for implantation.

Detailed Description
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A corneal topographer/biometer named GALILEI G6 Lens Professional was developed by Ziemer Ophthalmic Systems AG for the measurement of anterior segment geometry and axial intraocular distances. The measurement principle of the corneal topographer corresponds to that of the commercially available Galilei G4 Dual Scheimpflug Analyzer, whereas the measurement principle of the biometer is based on low coherence interferometry/reflectometry, which has been widely used and applied clinically by a number of predicate devices. One complete measurement consists of a corneal topography/ tomography scan followed by three consecutive, axial biometry scans of the anterior segment (cornea and crystalline lens) and three consecutive, axial biometry scans of the retina. The measurement process is continuous but divided into three alignment-click-steps. Such measurements can be applied to given Intra Ocular Lens (IOL) types and IOL equations, to permit the calculation of recommended IOLs to be implanted during cataract surgery in order to achieve the desired vision correction. The primary objectives of this clinical study are to: 1) evaluate the inter-device repeatability, inter-operator repeatability and reproducibility of the GALILEI G6 Lens Professional in repeated measurements of anterior segment geometry and axial intraocular distances and, 2) demonstrate substantial equivalence through examining agreement of the GALILEI measurements to those of the predicate device, the Pentacam® AXL.

Official Title
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GALILEI G6 Lens Professional vs. a Predicate Device: a Comparison Study

Conditions
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Cataract

Intervention / Treatment
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* Device: GALILEI G6 Lens Professional
* Device: Oculus Pentacam AXL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Satisfies one of the subject group categories and the enrollment quota for that category has not been reached: Normal eyes (phakic eyes without cataracts or corneal disease, refraction ≥ -5.5 D or ≤ +5.0 D) Eyes having undergone previous refractive surgery (LASIK or PRK) Eyes with cataracts (LOCS III grading with grades 2-6 in any or all of the posterior subcapsular (P2-P5), nuclear (N2-N5) and cortical (C2-C5), assessed by slit lamp examination; no other known ocular pathology) Eyes with severe myopia (≤ -6 D according to the American Academy of Ophthalmology) Eyes with severe hyperopia (≥ +5.25 D according to the American Academy of Ophthalmology) Eyes with previous cross-linking and eyes with advanced keratoconus Manifest refraction sSpherical eEquivalent Refraction (MRSER) between -10dpt and +10dpt as measured by cycloplegic autorefraction assessed less than 12 months prior to enrollment Best corrected visual acuity (BCVA) of LogMAR 0.2 or better Exclusion Criteria: Strabismus, nystagmus, amblyopia, anisometropia (difference in MRSER>3D) Angle closure glaucoma Seizure disorder, brain damage, Down Syndrome, Trisomy 13 or 18, Cerebral Palsy or other serious ophthalmic or central nervous system disorders Severe dry eye Severe corneal scarring Inability to hold gaze Inability to see fixation target

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GALILEI G6 Lens Professional<br>The GALILEI G6 Lens Professional will measure anterior segment geometry and axial intra-ocular distances of the eye. | Device: GALILEI G6 Lens Professional<br>* Eight measurements of the eye using the GALILEI G6 Lens Professional will be taken using two different devices and 2 different operators<br>|
| Active Comparator: Oculus Pentacam AXL<br>The Oculus Pentacam AXL will measure anterior segment geometry and axial intra-ocular distances of the eye. | Device: Oculus Pentacam AXL<br>* A single measurement of the eye will be taken using the Oculus Pentacam AXL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Length (AL) Measurement in millimeters (mm) | Repeatability and reproducability across and between evaluations | One day | 
| Central Corneal Thickness (CCT) Measurement in micrometers (µm) | Repeatability and reproducability across and between evaluations | One day | 
| Radius Flat Meridian (R flat) Measurement in millimeters (mm) | Repeatability and reproducability across and between evaluations | One day | 
| Radius Steep Meridian (R steep) Measurement in millimeters (mm) | Repeatability and reproducability across and between evaluations | One day | 
| Mean Radius (Rm) Measurement in millimeters (mm) | Repeatability and reproducability across and between evaluations | One day | 
| Corneal Cylinder Measurement in diopters (D) | Repeatability and reproducability across and between evaluations | One day | 
| Corneal Cylinder Axis (A flat) Measurement in degrees | Repeatability and reproducability across and between evaluations | One day | 
| Anterior Chamber Depth (ACD) Measurement in millimeters (mm) | Repeatability and reproducability across and between evaluations | One day | 
| Horizontal White-to-White distance (WtW) Measurement in millimeters (mm). | Repeatability and reproducability across and between evaluations | One day |