Clinical trial NCT05735990: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Presbyopia
Hyperopia
Myopia
Pseudophakia
Lead sponsor: Medicontur Medical Engineering Ltd
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (18 years old and older) with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia, who has binocular 640PM IOL implantation.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Corrected distance visual acuity (CDVA);
timeFrame: 12 months after IOL implantation
Secondary outcomes:
measure: visual acuity at all intended distances (UDVA; CDVA, UIVA, DCIVA, UNVA, DCNVA)
timeFrame: 1 and 12 months after IOL implantation;
measure: Manifest spherical equivalent refraction (SEQ)
timeFrame: 3 and 12 months after IOL implantation
measure: VADC (monocular with best distance correction) under photopic conditions
timeFrame: 3 months after IOL implantation
measure: CSDC (monocular with best distance correction): To evaluate CSDC under photopic conditions
timeFrame: 3 months after IOL implantation;
measure: CSDC (binocular without best distance correction) under photopic and mesopic conditions
timeFrame: 12 months after IOL implantation;
measure: Visual Function by VF-14
timeFrame: 12 months after IOL implantation;
measure: Patient satisfaction self-reported by the participant
timeFrame: 12 months after IOL implantation
measure: Visual disturbances (photic phenomena, dysphotopsia) self-reported by the participant
timeFrame: 12 months after IOL implantation
measure: spectacle independence self-reported by the participant
timeFrame: 12 months after IOL implantation
Other outcomes:
measure: Secondary surgical intervention rate
timeFrame: 12 months after IOL implantation;
measure: Collect and evaluate ocurrence of adverse events detected
timeFrame: from surgery to 12 months after IOL implantation
measure: PCO rate
timeFrame: 12 months after IOL implantation
measure: Nd-YAG capsulotomy rate
timeFrame: 12 months after IOL implantation
Locations:
city: Almería
country: Spain
facility: Hospital Vithas Almería
Study officials:
References: