Trials / Completed
CompletedNCT04220255
Clinical Outcome at 5 Years After Implantation of the Liberty677MY Multifocal Intraocular Lens
Clinical Outcome at 5 Years After Implantation of Medicontur Multifocal Intraocular Lens Liberty 677MY: Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Medicontur Medical Engineering Ltd · Industry
- Sex
- All
- Age
- 40 Years – 86 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Liberty677MY Multifocal IOL | multifocal intraocular lens (IOL) |
Timeline
- Start date
- 2019-11-01
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2020-01-07
- Last updated
- 2023-06-01
Locations
1 site across 1 country: Hungary
Source: ClinicalTrials.gov record NCT04220255. Inclusion in this directory is not an endorsement.