NCT04220255

Brief Summary

The study will assess visual outcomes, light disturbances and patients' satisfaction after implantation with the Liberty677MY multifocal IOL, as well as protection of PCO development within 5 year follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

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

November 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

December 20, 2019

Last Update Submit

May 31, 2023

Conditions

Cataract

Outcome Measures

Primary Outcomes (8)

  • Uncorrected Decimal VA (6 m)

    Visual acuity (VA) was tested monocularly (each eye separately) and binocularly (both eyes together) 5 years after implantation, unaided at a distance of 6 meters (m) using Early Treatment Diabetic Retinopathy ( ETDRS) charts and assessed in logarithm of the minimum angle of resolution (LogMAR).

    5 years after implantation

  • Uncorrected Decimal VA (60 cm)

    Visual acuity (VA) was tested monocularly (each eye separately) and binocularly (both eyes together) 5 years after implantation, unaided at a distance of 60 centimeters (cm) using ETDRS charts, assessed in LogMAR.

    5 years after implantation

  • Uncorrected Decimal VA (40 cm)

    Visual acuity (VA) was tested monocularly (each eye separately) and binocularly (both eyes together) 5 years after implantation, unaided at a distance of 40 centimeters (cm) using ETDRS charts, assessed in LogMAR.

    5 years after implantation

  • Corrected Decimal VA (6 m)

    Visual acuity (VA) was tested monocularly (each eye separately) and binocularly (both eyes together) 5 years after implantation, unaided at a distance of 6 meters (m) using ETDRS charts, assessed in LogMAR.

    5 years after implantation

  • Corrected Decimal VA (60 cm)

    Visual acuity (VA) was tested monocularly (each eye separately) and binocularly (both eyes together) 5 years after implantation, unaided at a distance of 60 centimeters (cm) using ETDRS charts , assessed in LogMAR.

    5 years after implantation

  • Corrected Decimal VA (40 cm)

    Visual acuity (VA) was tested monocularly (each eye separately) and binocularly (both eyes together) 5 years after implantation, unaided at a distance of 40 centimeters (cm) using ETDRS charts, assessed in LogMAR.

    5 years after implantation

  • Defocus Curve Profiles

    Visual acuity measurement (assessed in logarithm of the minimum angle of resolution (LogMAR)) taken with different levels of optical defocus was tested monocularly (each eye separately) and binocularly (both eyes together).

    5 years after implantation

  • Contrast Sensitivity CSV-1000

    Binocular Assessment of contrast sensitivity at threshold using the Contrast sensitivity vision (CSV) CSV-1000 in photopic and mesopic conditions with or without glare.

    5 years after implantation

Secondary Outcomes (1)

  • Posterior capsule opacification (PCO) rate

    5 years after implantation

Interventions

Liberty677MY Multifocal IOLDEVICE

multifocal intraocular lens (IOL)

Eligibility Criteria

Age40 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pseudophakic patients implanted with Liberty 677MY in 2014-2015 during the study under the ethical approval: 059823/2014/OTIG

You may qualify if:

  • pseudophakic patients implanted with Liberty 677MY in 2014-2015 during the study under the ethical approval: 059823/2014/OTIG

You may not qualify if:

  • diabetic retinopathy
  • iris neovascularisation
  • serious intraoperative complications
  • congenital eye abnormality
  • glaucoma
  • pseudoexfoliation syndrome
  • amblyopia
  • uveitis
  • long-term anti-inflammatory treatment
  • AMD (advanced AMD)
  • retinal detachment
  • prior ocular surgery in personal medical history (except cataract surgery aiming the implantation of the multifocal IOL)
  • previous laser treatment
  • corneal diseases
  • severe retinal diseases (dystrophy, degeneration)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retinaszervíz Kft

Veszprém, 8200, Hungary

Location

Related Publications (1)

  • Gyory JF, Srinivasan S, Madar E, Balla L. Long-term performance of a diffractive-refractive trifocal IOL with centralized diffractive rings: 5-year prospective clinical trial. J Cataract Refract Surg. 2021 Oct 1;47(10):1258-1264. doi: 10.1097/j.jcrs.0000000000000670.

    PMID: 33974369DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2019

First Posted

January 7, 2020

Study Start

November 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations

HU(1)