Clinical Outcome After Implantation of Two Different Multifocal Toric IOLs: Liberty (677MTY) and PanOptix®

NCT ID: NCT05895396

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-14

Study Completion Date

2024-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Liberty

The group implanted with Liberty 677MTY

No interventions assigned to this group

PanOptix

The group implanted with PanOptix

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medicontur Medical Engineering Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

József F Győry, MD

Role: PRINCIPAL_INVESTIGATOR

Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Retinaszervíz

Veszprém, , Hungary

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hungary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

677MTY _PanOptix_HU_2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.