Retinaszervíz
Veszprém, 8200, Hungary
NCT Number: NCT05895396
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.
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Notify Me18 year and older
All sexes
Observational
Veszprém, 8200, Hungary
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.
Only the study team can determine whether someone qualifies for participation.
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
Time frame: Day 1
Rotational stability will be measured using slit lamp images of the implanted lens
Time frame: 3 months
Rotational stability will be measured using slit lamp images of the implanted lens
Time frame: 1 year
Rotational stability will be measured using slit lamp images of the implanted lens
Time frame: 1 month
Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart.
Time frame: 3 months
Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart
Time frame: 1 year
Monocular and binocular visual aquity will be measured at far, intermediate and near distances by standard ETDRS chart
Time frame: 3 months
Contrast sensitivity defocus curve will be assessed using the Multifocal Lense Analyser iPAD application.
Time frame: 1 year
Contrast sensitivity defocus curve will be assessed using the Multifocal Lense Analyser iPAD application.
Time frame: 1 year
Contrast sensitivity in photopic and mesopic light conditions with or without glare will be assessed one year postoperatively using CSV-1000
Time frame: 3 months
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
Time frame: 1 year
The multifocality of the lens will be evaluated also by monocular and binocular visual acuity defocus curves using the multifocal lens analyser iPAD application.
Time frame: 3 months
Patient satisfaction will be measures with the VFQ-14 questionnaire
Time frame: 1 year
Patient satisfaction will be measures with the VFQ-14 questionnaire
Time frame: Day1 postoperatively
Intraoperative complications of cataract surgery
Time frame: Month1 postoperatively
Postoperative complications of cataract surgery
Time frame: Month 12 postoperatively
Complications of IOL implantation
Medicontur Medical Engineering Ltd
Industry
Comparison of Clinical Outcome After Implantation With Two Different Multifocal Toric Intraocular Lens: Liberty Trifocal 677MTY (Medicontur) and PanOptix® Multifocal Toric (Alcon) Lens, With Respect to Rotational Stability, Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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