Clinical trial NCT05895396: Clinical Outcome After Implantation of Two Different Multifocal Toric IOLs: Liberty (677MTY) and PanOptix®
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Medicontur Medical Engineering Ltd
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cataract

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Rotational stability
timeFrame: Day 1
measure: Rotational stability
timeFrame: 3 months
measure: Rotational stability
timeFrame: 1 year
Secondary outcomes:
measure: Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)
timeFrame: 1 month
measure: Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)
timeFrame: 3 months
measure: Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)
timeFrame: 1 year
measure: Contrast sensitivity defocus curve
timeFrame: 3 months
measure: Contrast sensitivity defocus curve
timeFrame: 1 year
measure: Contrast sensitivity
timeFrame: 1 year
measure: Multifocality (Visual Acuity Defocus Curve)
timeFrame: 3 months
measure: Multifocality (Visual Acuity Defocus Curve)
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 3 months
measure: Patient satisfaction
timeFrame: 1 year
Other outcomes:
measure: Safety outcome - Intraoperative complications
timeFrame: Day1 postoperatively
measure: Safety outcome - Postoperative complications
timeFrame: Month1 postoperatively
measure: Safety outcome - Complications of IOL implantation
timeFrame: Month 12 postoperatively
Locations:
city: Veszprém
country: Hungary
facility: Retinaszervíz
Study officials:
affiliation: Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary)
name: József F Győry, MD
role: PRINCIPAL_INVESTIGATOR
References: