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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04220255
• Other study ID #: MC_Liberty677MY_HU_2019
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2023
• Source: Medicontur Medical Engineering Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 86 Years

Eligibility

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°

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Liberty677MY Multifocal IOL
multifocal intraocular lens (IOL)

Locations

Country	Name	City	State
Hungary	Retinaszervíz Kft	Veszprém

Sponsors (1)

Lead Sponsor	Collaborator
Medicontur Medical Engineering Ltd

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Posterior capsule opacification (PCO) rate		5 years after implantation