NCT02990689

Brief Summary

The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

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

March 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

3.1 years

First QC Date

December 6, 2016

Last Update Submit

September 4, 2018

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

  • Intermediate visual acuity

    12 months

Secondary Outcomes (2)

  • Distance visual acuity

    12 months

  • Near visual acuity

    12 months

Study Arms (3)

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

Trifocal Intraocular LensDEVICE

bifocal intraocular lens (IOL)

839MP
Bifocal Intraocular LensDEVICE

trifocal intraocular lens (IOL)

809M
Low Addition Bifocal Intraocular LensDEVICE

low near addition intraocular lens (IOL)

SN6AD1

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 13, 2016

Study Start

March 1, 2012

Primary Completion

April 1, 2015

Study Completion

October 1, 2015

Last Updated

September 6, 2018

Record last verified: 2018-09