Clinical Study to Evaluate the Visual Performance of Thre... | NCT02990689

Studies
Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs

NCT02990689

Sponsor

Carl Zeiss Meditec AG

Status

Completed

Last Update Posted

Sep 6, 2018Actual

Enrollment

55Actual

Phase

Not Applicable

Conditions

Visual Acuity

Interventions

Trifocal Intraocular Lens
Bifocal Intraocular Lens
Low Addition Bifocal Intraocular Lens

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Apr 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Dec 6, 2016

First Submission Date that Met QC Criteria

Dec 8, 2016

First Posted Date

Dec 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2018

Last Update Posted Date

Sep 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
809M	Active Comparator	bifocal intraocular lens (IOL)	Device: Bifocal Intraocular Lens
839MP	Active Comparator	trifocal intraocular lens (IOL)	Device: Trifocal Intraocular Lens
SN6AD1	Active Comparator	bifocal intraocular lens (IOL)	Device: Low Addition Bifocal Intraocular Lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trifocal Intraocular Lens	Device	bifocal intraocular lens (IOL)	839MP

Measure	Description	Time Frame
Intermediate visual acuity		12 months

Measure	Description	Time Frame
Distance visual acuity		12 months
Near visual acuity		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of any gender, aged 50 to 80 years
Signed informed consent form
Healthy eyes besides cataract
Assured follow-up examinations
Stable corneal conditions within the last 12 months
Corneal astigmatism less than 1D
Implantation into the capsular bag by injector

Exclusion Criteria:

Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
Pseudophakia
Cornea guttata; keratoplasty
Irregular astigmatism (e.g. Keratoconus)
Corneal scarring
Diabetic retinopathy
Aniridia
Amblyopia
Amotio operation; anamnesis with vitreous surgery
Pseudoexfoliation Syndrome; Uveitis
Previous intraocular and corneal surgery
Intraocular tumours; endotamponade
Glaucoma or IOP higher than 24mmHg
Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 logMAR
Need for a dioptre out of the range of +16.0D to +26.0D
Inability to achieve secure lens placement in the capsular bag
Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
Intraoperative complications, damaged posterior bag, intraocular haemorrhage, can opener rhexis
Pregnancy or lactation period for female patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided