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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: GALILEI G6 Lens Professional; Device: Oculus Pentacam AXL

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Port, Switzerland
    • Ziemer Ophthalmic Systems AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Satisfies one of the subject group categories and the enrollment quota for that category has not been reached:

  1. Normal eyes (phakic eyes without cataracts or corneal disease, refraction ≥ -5.5 D or ≤ +5.0 D)
  2. Eyes having undergone previous refractive surgery (LASIK or PRK)
  3. 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)
  4. Eyes with severe myopia (≤ -6 D according to the American Academy of Ophthalmology)
  5. Eyes with severe hyperopia (≥ +5.25 D according to the American Academy of Ophthalmology)
  6. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ziemer Ophthalmic Systems AG
• Investigators: Principal Investigator: Majid Moshirfar, MD

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ZIEMER_G6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes