Clinical Outcome After Implantation With Two Different Multifocal Toric IOL: Liberty Trifocal 677MTY and PanOptix® Multifocal Toric
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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, glass independency, visual disturbances (glares, halos), neuronal adaptation and patient satisfaction after implantation with either 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®, manufactured by Alcon.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Liberty The group implanted with Liberty 677MTY |
|
| PanOptix The group implanted with PanOptix |
Outcome Measures
Primary Outcome Measures
- Rotational stability [Day 1]
Rotational stability will be measured using slit lamp images of the implanted lens
- Rotational stability [3 months]
Rotational stability will be measured using slit lamp images of the implanted lens
- Rotational stability [1 year]
Rotational stability will be measured using slit lamp images of the implanted lens
- Visual outcome [1 month]
Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart.
- Visual outcome [3 months]
Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart
- Visual outcome [1 year]
Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart
- Contrast sensitivity defocus curve [3 months]
Contrast sensitivity defocus curve will be assesses using the Multifocal Lense Analyser iPAD application .
- Contrast sensitivity defocus curve [1 year]
Contrast sensitivity defocus curve will be assesses using the Multifocal Lense Analyser iPAD application.
- Contrast sensitivity [1 year]
Contrast sensitivity in photopic and mesopic light conditions with or without glare will be assessed one year postoperatively using CSV-1000
- Multifocality [3 months]
The multifocality of the lens will be evaluated also by monocular and binocular defocus curves using the multifocal lens analyser iPAD application
- Multifocality [1 year]
The multifocality of the lens will be evaluated also by monocular and binocular defocus curves using the multifocal lens analyser iPAD application.
- Patient satisfaction [3 months]
Patient satisfaction will be measures with the VFQ-14 questionnaire
- Patient satisfaction [1 year]
Patient satisfaction will be measures with the VFQ-14 questionnaire
Eligibility Criteria
Criteria
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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astigmatism less than 1 dpt
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irregular astigmatism
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diabetic retinopathy
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iris neovascularisation
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serious intraoperative complications
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congenital eye abnormality
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glaucoma
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pseudoexfoliation syndrom
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amblyopia
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uveitis
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long-term anti-inflammatory treatment
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AMD (advanced AMD)
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retinal detachment
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prior ocular surgery in personal medical history
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corneal diseases
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severe retinal diseases (dystrophy, degeneration)
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severe myopia (if required IOL power is lower than 10 D)
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inadequate visualization of the fundus on preoperative examination
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patients deemed by the clinical investigator because of any systemic disease.
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eye trauma in medical history intraoperative exclusions:
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tear in capsulorhexis
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zonular dehiscence
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posterior capsular rupture
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vitreous loss and other unexpected surgical complication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Retinaszervíz | Veszprém | Hungary | 8200 |
Sponsors and Collaborators
- Medicontur Medical Engineering Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 677MTY _PanOptix_HU_2020