Clinical Outcome After Implantation of Two Different Multifocal Toric IOLs: Liberty (677MTY) and PanOptix®
- Conditions
- Cataract
- Registration Number
- NCT05895396
- Lead Sponsor
- Medicontur Medical Engineering Ltd
- 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.
- 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, 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
The enrolled subjects will be the patients with cataract and pre-existing regular corneal astigmatism between 1.0 to 6.0 dpt.
- astigmatism less than 1 dpt
- irregular astigmatism
- diabetic retinopathy
- iris neovascularisation
- serious intraoperative complications
- congenital eye abnormality
- glaucoma
- pseudoexfoliation syndrom
- amblyopia
- uveitis
- long-term anti-inflammatory treatment
- AMD (advanced AMD)
- retinal detachment
- prior ocular surgery in personal medical history
- corneal diseases
- severe retinal diseases (dystrophy, degeneration)
- severe myopia (if required IOL power is lower than 10 D)
- inadequate visualization of the fundus on preoperative examination
- patients deemed by the clinical investigator because of any systemic disease.
- eye trauma in medical history intraoperative exclusions:
- tear in capsulorhexis
- zonular dehiscence
- posterior capsular rupture
- vitreous loss and other unexpected surgical complication
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rotational stability 1 year Rotational stability will be measured using slit lamp images of the implanted lens
- Secondary Outcome Measures
Name Time Method Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA) 1 year Monocular and binocular visual aquity will be measured at far, intermediate and near distances by standard ETDRS chart
Contrast sensitivity defocus curve 1 year Contrast sensitivity defocus curve will be assessed 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 (Visual Acuity Defocus Curve) 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.
Patient satisfaction 1 year Patient satisfaction will be measures with the VFQ-14 questionnaire
Trial Locations
- Locations (1)
Retinaszervíz
🇭🇺Veszprém, Hungary