Galilei Lens Professional vs. Predicate Devices: a Comparison Study

Not Applicable

Completed

Conditions: Cataract

Interventions: Device: Galilei Lens Professional
Device: IOLMaster
Device: Lenstar

Registration Number: NCT01961089

Lead Sponsor: Ziemer Ophthalmic Systems AG

Brief Summary: Study question: How does the new GALILEI Lens Professional compare to predicate devices? Study hypothesis: The GALILEI Lens Professional achieves a better precision in the postoperative, calculated target refraction with cataract surgeries than predicate devices, and it is more versatile in the measurable parameters as well as more user-friendly.

Detailed Description: Background: An accessory to the commercially available GALILEI Dual-Scheimpflug Corneal Topographer/Keratometer with the name "EBR Accessory" was developed by the company Ziemer Ophthalmic Systems AG for the measurement of intraocular distances. The combination is called "GALILEI Lens Professional". The measurement principle is based on on short coherence interferometry/-reflectometry, which has gained wide-spread application and has been applied clinically, including one of the members of this study group, for the precise measurement of axial, intraocular distances (12.1.). Such EBR Accessory measurements, in combination with measurements by the GALILEI, may be applied to given intra-ocular lens (IOL) types and IOL equations, an permit the calculation of suggested IOLs that are implanted during cataract surgery, in order to achieve the desired vision correction. To register this accessory for sale, the precision and agreement to existing devices with similar applications ("predicate devices") must be demonstrated. One complete measurement consists of a cornea-topography/keratometry scan, followed immediately by three consecutive, axial biometry scans of the anterior segment (cornea and crystalline lens) and - after a short re-alignment - three consecutive, axial biometry scans of the retina. The measurement process is continuous, but divided in two steps. Blinking by the patient is possible in between the two steps, which increases patient comfort and, in certain cases, measurement success. Precision is evaluated by three repeated, complete measurements with the GALILEI Lens Professional and each predicate device. Two standard devices with comparable optical technology that are used in routine cataract surgery were declared as predicate devices. These two devise are typically used in combination with standard keratometers, as which the GALILEI Lens Professional may be employed as well.

Goal: The comparison of the GALILEI Lens Professional to predicate devices with respect to precision in measuring postoperative, calculated target refractions in cataract patients, and versatility of measurable quantities.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

spherical equivalent between -10 D and +10 D
best-corrected VA of 20/100 or better.

Exclusion Criteria

strabism
blepharitis
nystagmus
amblyopia
anisometropia (spherical equivalent > 1D)
angle closure glaucoma
seizure disorder
brain damages
Down syndrome
trisomy 13 or 18
cerebral palsy
other serious disorders of the eye or central nervous systems

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal	Lenstar	Arm: Normal eyes Interventions: Galilei Lens Professional, IOLMaster, Lenstar
Severe cataract	Lenstar	Arm: Eyes with severe cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar
Mild Cataract	Lenstar	Arm: Eyes with mild cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar
Normal	Galilei Lens Professional	Arm: Normal eyes Interventions: Galilei Lens Professional, IOLMaster, Lenstar
Normal	IOLMaster	Arm: Normal eyes Interventions: Galilei Lens Professional, IOLMaster, Lenstar
Mild Cataract	IOLMaster	Arm: Eyes with mild cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar
Severe cataract	Galilei Lens Professional	Arm: Eyes with severe cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar
Mild Cataract	Galilei Lens Professional	Arm: Eyes with mild cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar
Severe cataract	IOLMaster	Arm: Eyes with severe cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar

Primary Outcome Measures

Name	Time	Method
Agreement With Predicate Devices in Terms of Agreement 1	3 months	Assessed parameters: Axial Length (AL; G6, IOLM, LS) Central Corneal Thickness (CCT; G6, LS)) Anterior Chamber Depth (ACD; G6, IOLM, LS) Lens Thickness (LT; G6, LS) Corneal Curvature (SimK; G6, IOLM, LS) White-to-White (WtW; G6, IOL, LS)
Agreement With Predicate Devices in Terms of Agreement 2	3 months	Assessed Parameters: Simulated Corneal Curvature (SimK; G6, IOLM, LS)

Secondary Outcome Measures

Name	Time	Method
Agreement With Devices of the Same Type in Terms of Repeatability	3 months	Assessed parameters: Axial Length (AL) Central Corneal Thickness (CCT) Anterior Chamber Depth (ACD) Lens Thickness (LT) Corneal Curvature (SimK) White-to-White (WtW)