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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liberty677MY Multifocal IOL | Device | multifocal intraocular lens (IOL) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Posterior capsule opacification (PCO) rate | 5 years after implantation |
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Inclusion Criteria:
Exclusion Criteria:
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Pseudophakic patients implanted with Liberty 677MY in 2014-2015 during the study under the ethical approval: 059823/2014/OTIG
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinaszervíz Kft | Veszprém | 8200 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33974369 | Derived | 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. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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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 |