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

Medicontur Medical Engineering Ltd21 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Cataract Presbyopia Hyperopia Myopia Pseudophakia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Corrected distance visual acuity (CDVA);

Time frame: 12 months after IOL implantation

Secondary Outcomes

visual acuity at all intended distances (UDVA; CDVA, UIVA, DCIVA, UNVA, DCNVA)

Time frame: 1 and 12 months after IOL implantation;

Manifest spherical equivalent refraction (SEQ)

Time frame: 3 and 12 months after IOL implantation

VADC (monocular with best distance correction) under photopic conditions

Time frame: 3 months after IOL implantation

CSDC (monocular with best distance correction): To evaluate CSDC under photopic conditions

Time frame: 3 months after IOL implantation;

CSDC (binocular without best distance correction) under photopic and mesopic conditions

Time frame: 12 months after IOL implantation;

Visual Function by VF-14

Time frame: 12 months after IOL implantation;

Patient satisfaction self-reported by the participant

Time frame: 12 months after IOL implantation

Visual disturbances (photic phenomena, dysphotopsia) self-reported by the participant

Time frame: 12 months after IOL implantation

spectacle independence self-reported by the participant

Time frame: 12 months after IOL implantation

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes