Cataract
Conditions
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.
Interventions
None listed
Sponsors
Medicontur Medical Engineering Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rotational stability | Day 1 | Rotational stability will be measured using slit lamp images of the implanted lens |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast sensitivity defocus curve | 3 months | 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) | 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 |
| Patient satisfaction | 3 months | Patient satisfaction will be measures with the VFQ-14 questionnaire |
| Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA) | 1 month | Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety outcome - Complications of IOL implantation | Month 12 postoperatively | Complications of IOL implantation * Posterior capsular opacification (PCO) * Opacification, IOL discoloration |
| Safety outcome - Postoperative complications | Month1 postoperatively | Postoperative complications of cataract surgery * Cystoid macular oedema * Iris abnormalities * Corneal oedema * Wound leak or rupture * IOL dislocation, removal, or exchange * Inflammation (Endophthalmitis, anterior chamber cells, anterior chamber flare, hypopyon) * Retinal tear, break, or detachment * Persistent iritis * Elevated intraocular pressure * Pupillary block * Cornea status |
| Safety outcome - Intraoperative complications | Day1 postoperatively | Intraoperative complications of cataract surgery * Posterior capsular or zonular rupture * Vitreous loss/anterior vitrectomy or aspiration * Iris/ciliary body injury * Loss of nuclear material into vitreous * Suprachoroidal haemorrhage * Retrobulbar haemorrhage |
Countries
Hungary
Outcome results
None listed