NCT03748381

Brief Summary

Compare two commercially available bilateral implanted diffractive trifocal lenses (Zeiss AT Lisa tri vs. Rayner trifocal) after cataract surgery concerning visual function and spectacle independence.

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
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

November 19, 2018

Last Update Submit

November 20, 2018

Conditions

Cataract

Keywords

Cataract surgeryTrifocal IOL

Outcome Measures

Primary Outcomes (1)

  • Uncorrected Near Visual Acuity

    Uncorrected Near Visual Acuity will be assessed with ETDRS charts

    12 months

Secondary Outcomes (5)

  • Uncorrected and Best corrected Far and Intermediate Visual Acuity,

    12 months

  • Halo measurements

    12 months

  • Reading speed

    12 months

  • Defocus curve

    12 months

  • Contrast sensitivity

    12 months

Study Arms (1)

Trifocal IOL

EXPERIMENTAL

The patients will receive two different diffractive trifocal IOLs in each eye (AT Lisa tri vs. Rayner trifocal) during cataract surgery

Procedure: Cataract surgery

Interventions

Cataract surgeryPROCEDURE

During cataract surgery patients will be implanted with the AT Zeiss Lisa tri in one eye and the Rayner trifocal in the contralateral eye

Trifocal IOL

Eligibility Criteria

Age21 Years - 105 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 700)
  • 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)

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Martin Kronschläger, MD

CONTACT

01 910 21-57572office@viros.at

Julius Hienert, MD

CONTACT

01 910 21-57562office@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 20, 2018

Study Start

April 1, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

AU(1)