Clinical Outcome After Implantation With Two Different Multifocal Toric IOL: Liberty Trifocal 677MTY and PanOptix® Multifocal Toric

Cataract Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05895396
• Other study ID #: 677MTY _PanOptix_HU_2020
• Status: Enrolling by invitation
• Start date: September 14, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2023
• Source: Medicontur Medical Engineering Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
Hungary	Retinaszervíz	Veszprém

Sponsors (1)

Lead Sponsor	Collaborator
Medicontur Medical Engineering Ltd

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rotational stability	Rotational stability will be measured using slit lamp images of the implanted lens	Day 1
Primary	Rotational stability	Rotational stability will be measured using slit lamp images of the implanted lens	3 months
Primary	Rotational stability	Rotational stability will be measured using slit lamp images of the implanted lens	1 year
Primary	Visual outcome	Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart.	1 month
Primary	Visual outcome	Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart	3 months
Primary	Visual outcome	Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart	1 year
Primary	Contrast sensitivity defocus curve	Contrast sensitivity defocus curve will be assesses using the Multifocal Lense Analyser iPAD application .	3 months
Primary	Contrast sensitivity defocus curve	Contrast sensitivity defocus curve will be assesses using the Multifocal Lense Analyser iPAD application.	1 year
Primary	Contrast sensitivity	Contrast sensitivity in photopic and mesopic light conditions with or without glare will be assessed one year postoperatively using CSV-1000	1 year
Primary	Multifocality	The multifocality of the lens will be evaluated also by monocular and binocular defocus curves using the multifocal lens analyser iPAD application	3 months
Primary	Multifocality	The multifocality of the lens will be evaluated also by monocular and binocular defocus curves using the multifocal lens analyser iPAD application.	1 year
Primary	Patient satisfaction	Patient satisfaction will be measures with the VFQ-14 questionnaire	3 months
Primary	Patient satisfaction	Patient satisfaction will be measures with the VFQ-14 questionnaire	1 year