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

Completed

• Conditions: Myopia; Cataract; Hyperopia; Pseudophakia; Presbyopia
• Interventions: Device: Intraocular lens

• Registration Number: NCT05735990
• Lead Sponsor: Medicontur Medical Engineering Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-27
• Study First Submitted: 2022-10-28
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-09
• Last Update Submitted: 2023-02-09
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
640PM implanted	Intraocular lens	Patients implanted binocularly with Medicontur's intraocular lens model 640PM.

Primary Outcome Measures

Name	Time	Method
Corrected distance visual acuity (CDVA);	12 months after IOL implantation

Secondary Outcome Measures

Name	Time	Method
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
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
visual acuity at all intended distances (UDVA; CDVA, UIVA, DCIVA, UNVA, DCNVA)	1 and 12 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;

Trial Locations

Locations (1)

Hospital Vithas Almería; 🇪🇸 Almería, Spain