NCT02155348

Brief Summary

More and more patients like to achieve complete spectacle independence after cataract surgery. Two possibilities that are particularly often used today are on the one hand multifocal lenses, and on the other hand the concept of monovision (in doing so one eye is adjusted for closeness and the other focuses for distance). The drawback with multifocal lenses is that some patients are bothered by glare phenomena, the disadvantage of monovision is that some patients lose a little of their stereo vision. The aim of this study is a direct comparison of these two methods. Therefore 70 patients are included in 2 groups. In one group, patients receive on both sides a multifocal IOL with a near addition of +1.5 D and the patients in the second group receive monovision. One hour, 1 week and 3 months after surgery, patients are invited and tests for visual accuity are performed for near vision (40cm), intermediate vision (80cm) and distant vision (400cm). Furthermore, contrast sensitivity and stereopsis of patients is assesed. Additional measurements for detecting the tilt of the lens will be performed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 4, 2014

Status Verified

June 1, 2014

Enrollment Period

1.6 years

First QC Date

June 2, 2014

Last Update Submit

June 3, 2014

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Spectacle independence of patients with bilateral multifocal intraocular lenses in comparison to patients with pseudophakic monovision evaluated using a questionnaire

    3 months

Secondary Outcomes (3)

  • Uncorrected and Best Corrected Distance Visual Acuity, Uncorrected and Distance Corrected Intermediate Visual Acuity, Uncorrected and Distance Corrected Near Visual Acuity between the test and the control group

    3 months

  • Reading Speed

    3 months

  • Stereo Vision and Contrast Sensibility

    3 months

Study Arms (2)

Multifocal group

ACTIVE COMPARATOR

Bilateral cataract surgery with implantation of multifocal IOLs

Procedure: Bilateral cataract surgery with implantation of multifocal IOLsDevice: Lentis LS-313

Monovision

ACTIVE COMPARATOR

Bilateral cataract surgery with monovision

Procedure: Bilateral cataract surgery with monovisionDevice: Lentis LS-313

Interventions

Bilateral cataract surgery with implantation of multifocal IOLsPROCEDURE

Lentis LS-313, multifocal, target refraction of the distance-dominant eye: 0.00D, target refraction of the other eye: -0.50D

Multifocal group
Bilateral cataract surgery with monovisionPROCEDURE

Lentis L-313, monofocal, target refraction of the distance-dominant eye: 0.00D to -0.25D, target refraction of the other eye: -1.50D

Monovision
Lentis LS-313DEVICE
MonovisionMultifocal group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age-related cataract
  • Scheduled for bilateral cataract extraction
  • Motivated to be less spectacle dependant
  • Age 21 and older
  • Corneal astigmatism ≤ 1.5 D (Keratometry, IOL Master 500)
  • written informed consent prior to recruitment

You may not qualify if:

  • Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
  • Retinitis pigmentosa
  • Chronic uveitis
  • Amblyopia
  • Pupil decentration \> 1mm center shift
  • preceded retinal surgery
  • preceded Laser-in-situ-Keratomileusis (LASIK)
  • Any ophthalmic abnormality that could compromise visual function or the measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital

Vienna, Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prim. Prof. Dr. Oliver Findl, MBA

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 4, 2014

Study Start

June 1, 2013

Primary Completion

January 1, 2015

Study Completion

May 1, 2015

Last Updated

June 4, 2014

Record last verified: 2014-06

Locations

AU(1)