Clinical trial NCT04220255: Clinical Outcome at 5 Years After Implantation of the Liberty677MY Multifocal Intraocular Lens
Official title: Clinical Outcome at 5 Years After Implantation of Medicontur Multifocal Intraocular Lens Liberty 677MY: Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Medicontur Medical Engineering Ltd
Sponsor class: INDUSTRY
First posted: 2020-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pseudophakic patients implanted with Liberty 677MY in 2014-2015 during the study under the ethical approval: 059823/2014/OTIG

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.

Detailed 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.

Eligibility criteria: 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°

Primary outcomes:
measure: Uncorrected Decimal VA (6 m)
timeFrame: 5 years after implantation
measure: Uncorrected Decimal VA (60 cm)
timeFrame: 5 years after implantation
measure: Uncorrected Decimal VA (40 cm)
timeFrame: 5 years after implantation
measure: Corrected Decimal VA (6 m)
timeFrame: 5 years after implantation
measure: Corrected Decimal VA (60 cm)
timeFrame: 5 years after implantation
measure: Corrected Decimal VA (40 cm)
timeFrame: 5 years after implantation
measure: Defocus Curve Profiles
timeFrame: 5 years after implantation
measure: Contrast Sensitivity CSV-1000
timeFrame: 5 years after implantation
Secondary outcomes:
measure: Posterior capsule opacification (PCO) rate
timeFrame: 5 years after implantation
Other outcomes:
Locations:
city: Veszprém
country: Hungary
facility: Retinaszervíz Kft
Study officials:
References:
citation: 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.