Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia

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

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-27

Study Completion Date

2023-01-31

Brief Summary

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

The clinical investigation objective is to evaluate safety and performance outcomes of trifocal IOL implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia.

Retrospective data from preoperative status up to 12 month postoperative status will be collected from patients that were implanted with Medicontur's 640PM intraocular lens:

* Preoperative status: Preoperative Screening and Baseline
* Surgery: IOL implantation
* M1: 1 month +/- 2 weeks postoperative follow-up
* M3: 3 months +/- 1 month postoperative follow-up
* M12: 12 months +/- 3 months postoperative follow-up

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens

NCT06578910

Cataract Pseudophakia

COMPLETED

Prospective Multicenter Clinical Study on the Visual and Refractive Outcomes and Safety Outcomes Following Implantation of an AddOn Intraocular Lens in Previously Pseudophakic Eyes

NCT05596682

Presbyopia Refractive Errors Residual Astigmatism

UNKNOWN

Retrospective, Non-interventional, Comparative Clinical Investigation of the Safety and Performance of 690AD and 690ADY Monofocal Intraocular Lens Implantation With Extended Patient Enrolment

NCT06578923

Cataract Pseudophakia Intraocular Lens Complication +1 more

COMPLETED

Evaluation of Safety and Performance Outcomes of Eyedeal IOL Implantation After Cataract Removal

NCT05776095

Lens Implantation, Intraocular

RECRUITING NA

Presbyopia-Correcting Intraocular Lenses (IOLs)

NCT00963560

Cataract

COMPLETED PHASE4

Detailed Description

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

Conditions

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

Cataract Presbyopia Hyperopia Myopia Pseudophakia

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

RETROSPECTIVE

Study Groups

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

640PM implanted

Patients implanted binocularly with Medicontur's intraocular lens model 640PM.

Intraocular lens

Intervention Type DEVICE

Aspheric hydrophilic acrylic IOL for implantation into the capsular bag

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intraocular lens

Aspheric hydrophilic acrylic IOL for implantation into the capsular bag

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Adult males or females above 18 years of age;
* Pseudophakic patients implanted with 640PM IOLs (Medicontur Medical Engineering Ltd. Inc., Zsámbék, Hungary);
* Diagnosis of cataract and/or ametropia and/or presbyopia;
* Subject who provided express consent authorizing the use of medical record data for biomedical research purposes. Patients who have participated in at least two follow up visits in the 12 months following IOL implantation
* Patients for which the retrospective data for the primary endpoint is available and at least half of all the secondary endpoints measured in the time ranges specified in the protocol.

Exclusion Criteria

* Patients with any eye condition that could affect vision (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.);
* regular anterior corneal astigmatism ≥ 1.20 D or irregular astigmatism ≥ 0.5 μm measured with Pentacam at 4 mm.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No