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Completed

NCT Number: NCT04220255

Clinical Outcome at 5 Years After Implantation of the Liberty677MY Multifocal Intraocular Lens

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year–86 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Retinaszervíz Kft

Veszprém, 8200, Hungary

About this study

The Liberty677MY multifocal IOL is designed for restoring near, intermediate and distance vision. The technology of Liberty 677MY is based on the elevated phase shift technology (patent pending). Previous evaluations showed the strength of studied IOL both in laboratory and clinical conditions.

Patients will be examined 5 years after implantation. The examination will include the measurement of the best corrected distance, intermediate and near visual acuity (assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) charts), intraocular pressure (contact Goldman tonometry), biomicroscopic and fundocsopic examination, contrast sensitivity (CSV-1000), defocus curve, reading capability, pupilometry in different light conditions and PCO evaluation, Nd:YAG capsulotomy rate, photo-documentation of anterior segment. YAG capsulotomy will be indicated in case of posterior capsule opacification (PCO). The criteria for YAG capsulotomy will be visual acuity decreased 2 or more lines when using (ETDRS) charts. Details of all related and unrelated complications will be documented, including severity, time of onset, specific treatment and clinical outcome. The investigators will also record whether the capsulorhexis is on or partially off the optic.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • severe myopia (if required IOL power is lower than 10 D)
  • inadequate visualization of the fundus on preoperative examination
  • patients deemed by the clinical investigator because of any systemic disease.
  • pregnancy
  • eye trauma in medical history
  • current use of systemic steroids or topical ocular medication
  • preoperative smaller pupil size of 6 mm under topical mydriasis
  • kappa angle >5°

Treatment and study plan

Liberty677MY Multifocal IOL

Device

multifocal intraocular lens (IOL)

Primary outcomes

  1. Uncorrected Decimal VA (6 m)

    Time frame: 5 years after implantation

    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).

  2. Uncorrected Decimal VA (60 cm)

    Time frame: 5 years after implantation

    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.

  3. Uncorrected Decimal VA (40 cm)

    Time frame: 5 years after implantation

    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.

  4. Corrected Decimal VA (6 m)

    Time frame: 5 years after implantation

    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. Corrected Decimal VA (60 cm)

    Time frame: 5 years after implantation

    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.

  6. Corrected Decimal VA (40 cm)

    Time frame: 5 years after implantation

    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.

  7. Defocus Curve Profiles

    Time frame: 5 years after implantation

    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).

  8. Contrast Sensitivity CSV-1000

    Time frame: 5 years after implantation

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

Secondary outcomes

  1. Posterior capsule opacification (PCO) rate

    Time frame: 5 years after implantation

Sponsors and collaborators

Lead sponsor

Medicontur Medical Engineering Ltd

Industry

Registry information

Official study title

Clinical Outcome at 5 Years After Implantation of Medicontur Multifocal Intraocular Lens Liberty 677MY: Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 7, 2020
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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