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

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

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia; Myopia; Hyperopia; Pseudophakia
• Intervention / Treatment: Device: Intraocular lens

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Spain
  • Almería, Spain, 04120
    • Hospital Vithas Almería

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults (18 years old and older) with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia, who has binocular 640PM IOL implantation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
640PM implanted; Patients implanted binocularly with Medicontur's intraocular lens model 640PM.	Device: Intraocular lens; Aspheric hydrophilic acrylic IOL for implantation into the capsular bag

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Corrected distance visual acuity (CDVA);	12 months after IOL implantation

Secondary Outcome Measures

Outcome Measure	Time Frame
visual acuity at all intended distances (UDVA; CDVA, UIVA, DCIVA, UNVA, DCNVA)	1 and 12 months after IOL implantation;
Manifest spherical equivalent refraction (SEQ)	3 and 12 months after IOL implantation
VADC (monocular with best distance correction) under photopic conditions	3 months after IOL implantation
CSDC (monocular with best distance correction): To evaluate CSDC under photopic conditions	3 months after IOL implantation;
CSDC (binocular without best distance correction) under photopic and mesopic conditions	12 months after IOL implantation;
Visual Function by VF-14	12 months after IOL implantation;
Patient satisfaction self-reported by the participant	12 months after IOL implantation
Visual disturbances (photic phenomena, dysphotopsia) self-reported by the participant	12 months after IOL implantation
spectacle independence self-reported by the participant	12 months after IOL implantation

Other Outcome Measures

Outcome Measure	Time Frame
Secondary surgical intervention rate	12 months after IOL implantation;
Collect and evaluate ocurrence of adverse events detected	from surgery to 12 months after IOL implantation
PCO rate	12 months after IOL implantation
Nd-YAG capsulotomy rate	12 months after IOL implantation

Collaborators and Investigators

• Sponsor: Medicontur Medical Engineering Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Estimate): February 20, 2023

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia; Myopia; Hyperopia; Pseudophakia
• Other Study ID Numbers: M_640PM_ES_2202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No