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

Sponsor

Medicontur Medical Engineering Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT05735990

Collaborator

(none)

Enrollment

Location

3.2

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract Presbyopia Hyperopia Myopia Pseudophakia	Device: Intraocular lens

Study Design

Study Type:

Observational

Actual Enrollment :

21 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 27, 2022

Actual Primary Completion Date :

Jan 31, 2023

Actual Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Corrected distance visual acuity (CDVA); [12 months after IOL implantation]

Secondary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.