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This study is to compare the rotational stability, visual outcome and patient satisfaction after implantation with either Liberty 677MTY, a multifocal diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. (Zsámbék, Hungary) or the multifocal toric IOL PanOptix®, manufactured by Alcon.
According to numerous estimations, 15% to 29% of patients with cataract have more than 1.5 diopters of refractive astigmatism. Corneal astigmatism can be reduced with a variety of surgical techniques including selective positioning of the phacoemulsification incision, corneal relaxing incision, implantation of toric IOLs, photorefractive keratectomy and there are first results of implantation of short arc-length intrastromal corneal ring segments for correcting astigmatism and myopia . The use of toric IOLs to reduce visually significant keratometric astigmatism offers a rational, more predictable and stable method of refractive correction. Implanting a toric intraocular lens offers the possibility of correcting not only spherical equivalent of refraction, but also astigmatism. The success of a toric IOL can be judged not only by its ability to reduce refractive astigmatism immediately postoperatively, but also by its ability to maintain a stable position in the capsular bag in the longer term. Even a small rotational deviation of the toric IOL from its intended axis can result in large reduction of the astigmatic correction.
The purpose of this study is to evaluate and compare the visual outcomes, spectacle independency, visual disturbances (glares, halos), neuronal adaptation and patient satisfaction after implantation of either the Liberty 677MTY (a multifocal diffractive apodized toric intraocular lens- diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. Zsámbék, Hungary) or the multifocal toric PanOptix® IOL, manufactured by Alcon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberty | The group implanted with Liberty 677MTY | ||
| PanOptix | The group implanted with PanOptix |
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| Measure | Description | Time Frame |
|---|---|---|
| Rotational stability | Rotational stability will be measured using slit lamp images of the implanted lens | Day 1 |
| Rotational stability | Rotational stability will be measured using slit lamp images of the implanted lens | 3 months |
| Rotational stability | Rotational stability will be measured using slit lamp images of the implanted lens | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA) | Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart. | 1 month |
| Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome - Intraoperative complications | Intraoperative complications of cataract surgery
| Day1 postoperatively |
Inclusion Criteria:
The enrolled subjects will be the patients with cataract and pre-existing regular corneal astigmatism between 1.0 to 6.0 dpt.
Exclusion Criteria:
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Patients with cataract
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| Name | Affiliation | Role |
|---|---|---|
| József F Győry, MD | Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinaszervíz | Veszprém | 8200 | Hungary |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart
| 3 months |
| Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA) | Monocular and binocular visual aquity will be measured at far, intermediate and near distances by standard ETDRS chart | 1 year |
| Contrast sensitivity defocus curve | Contrast sensitivity defocus curve will be assessed using the Multifocal Lense Analyser iPAD application. | 3 months |
| Contrast sensitivity defocus curve | Contrast sensitivity defocus curve will be assessed using the Multifocal Lense Analyser iPAD application. | 1 year |
| Contrast sensitivity | Contrast sensitivity in photopic and mesopic light conditions with or without glare will be assessed one year postoperatively using CSV-1000 | 1 year |
| Multifocality (Visual Acuity Defocus Curve) | The multifocality of the lens will be evaluated also by monocular and binocular visual acuity defocus curves (VADC) using the multifocal lens analyser iPAD application | 3 months |
| Multifocality (Visual Acuity Defocus Curve) | The multifocality of the lens will be evaluated also by monocular and binocular visual acuity defocus curves using the multifocal lens analyser iPAD application. | 1 year |
| Patient satisfaction | Patient satisfaction will be measures with the VFQ-14 questionnaire | 3 months |
| Patient satisfaction | Patient satisfaction will be measures with the VFQ-14 questionnaire | 1 year |
| Safety outcome - Postoperative complications |
Postoperative complications of cataract surgery
|
| Month1 postoperatively |
| Safety outcome - Complications of IOL implantation | Complications of IOL implantation
| Month 12 postoperatively |