NCT03396003

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

November 20, 2017

Last Update Submit

September 24, 2018

Conditions

Cataract

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (2)

GALILEI G6 Lens Professional

EXPERIMENTAL

The GALILEI G6 Lens Professional will measure anterior segment geometry and axial intra-ocular distances of the eye.

Device: GALILEI G6 Lens Professional

Oculus Pentacam AXL

ACTIVE COMPARATOR

The Oculus Pentacam AXL will measure anterior segment geometry and axial intra-ocular distances of the eye.

Device: Oculus Pentacam AXL

Interventions

GALILEI G6 Lens ProfessionalDEVICE

Eight measurements of the eye using the GALILEI G6 Lens Professional will be taken using two different devices and 2 different operators

GALILEI G6 Lens Professional
Oculus Pentacam AXLDEVICE

A single measurement of the eye will be taken using the Oculus Pentacam AXL

Oculus Pentacam AXL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziemer Ophthalmic Systems AG

Port, Switzerland

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Majid Moshirfar, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

January 10, 2018

Study Start

January 5, 2018

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

September 26, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)