NCT01961089

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

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

Study Start

First participant enrolled

October 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

February 5, 2018

Completed
Last Updated

October 8, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

October 7, 2013

Results QC Date

January 16, 2015

Last Update Submit

September 26, 2019

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

  • Agreement With Predicate Devices in Terms of Agreement 1

    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)

    3 months

  • Agreement With Predicate Devices in Terms of Agreement 2

    Assessed Parameters: Simulated Corneal Curvature (SimK; G6, IOLM, LS)

    3 months

Secondary Outcomes (1)

  • Agreement With Devices of the Same Type in Terms of Repeatability

    3 months

Study Arms (3)

Normal

EXPERIMENTAL

Arm: Normal eyes Interventions: Galilei Lens Professional, IOLMaster, Lenstar

Device: Galilei Lens ProfessionalDevice: IOLMasterDevice: Lenstar

Mild Cataract

ACTIVE COMPARATOR

Arm: Eyes with mild cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar

Device: Galilei Lens ProfessionalDevice: IOLMasterDevice: Lenstar

Severe cataract

EXPERIMENTAL

Arm: Eyes with severe cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar

Device: Galilei Lens ProfessionalDevice: IOLMasterDevice: Lenstar

Interventions

Galilei Lens ProfessionalDEVICE

Measurement device

Mild CataractNormalSevere cataract
IOLMasterDEVICE

Measurement device

Mild CataractNormalSevere cataract
LenstarDEVICE

Measurement device

Mild CataractNormalSevere cataract

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Clinic Orasis

Reinach, Canton of Aargau, 5734, Switzerland

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Limitations and Caveats

Due to the the removal and non-repetition of poor-quality G6 measurements, the informative value of the repeatability results is limited. Direct comparison to the predicates is problematic, as poor-quality measurements with those were repeated.

Results Point of Contact

Title
Dr. Gregor Schmid
Organization
Ziemer Ophthalmic Systems AG
gregor.schmid@ziemergroup.com
+41323327154

Study Officials

  • Bojan Pajic, MD

    Eye Clinic Orasis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 11, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 8, 2019

Results First Posted

February 5, 2018

Record last verified: 2019-09

Locations

CH(1)