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 Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Myopia, Cataract, Presbyopia, Hyperopia, Pseudophakia

Intervention / Treatment
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* Device: Intraocular lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 640PM implanted<br>Patients implanted binocularly with Medicontur's intraocular lens model 640PM. | Device: Intraocular lens<br>* Aspheric hydrophilic acrylic IOL for implantation into the capsular bag<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |