Cataract, Hyperopia, Myopia, Presbyopia, Pseudophakia
Conditions
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
Interventions
DEVICEIntraocular lens
Aspheric hydrophilic acrylic IOL for implantation into the capsular bag
Sponsors
Medicontur Medical Engineering Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corrected distance visual acuity (CDVA); | 12 months after IOL implantation |
Secondary
| Measure | Time frame |
|---|---|
| Manifest spherical equivalent refraction (SEQ) | 3 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; |
| Visual Function by VF-14 | 12 months after IOL implantation; |
| visual acuity at all intended distances (UDVA; CDVA, UIVA, DCIVA, UNVA, DCNVA) | 1 and 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 |
| VADC (monocular with best distance correction) under photopic conditions | 3 months after IOL implantation |
Other
| Measure | Time frame |
|---|---|
| PCO rate | 12 months after IOL implantation |
| Nd-YAG capsulotomy rate | 12 months after IOL implantation |
| Collect and evaluate ocurrence of adverse events detected | from surgery to 12 months after IOL implantation |
| Secondary surgical intervention rate | 12 months after IOL implantation; |
Countries
Spain
Outcome results
None listed