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OpenTrials
Completed

NCT Number: 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

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

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Key information

Conditions

Cataract Eye Diseases Hyperopia Lens Diseases Myopia Pathological Conditions, Signs and Symptoms Presbyopia Pseudophakia Refractive Errors Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Vithas Almería

Almería, 04120, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraocular lens

Device

Aspheric hydrophilic acrylic IOL for implantation into the capsular bag

Primary outcomes

  1. Corrected distance visual acuity (CDVA);

    Time frame: 12 months after IOL implantation

Secondary outcomes

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

    Time frame: 1 and 12 months after IOL implantation;

  2. Manifest spherical equivalent refraction (SEQ)

    Time frame: 3 and 12 months after IOL implantation

  3. VADC (monocular with best distance correction) under photopic conditions

    Time frame: 3 months after IOL implantation

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

    Time frame: 3 months after IOL implantation;

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

    Time frame: 12 months after IOL implantation;

  6. Visual Function by VF-14

    Time frame: 12 months after IOL implantation;

  7. Patient satisfaction self-reported by the participant

    Time frame: 12 months after IOL implantation

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

    Time frame: 12 months after IOL implantation

  9. spectacle independence self-reported by the participant

    Time frame: 12 months after IOL implantation

Other outcomes

  1. Secondary surgical intervention rate

    Time frame: 12 months after IOL implantation;

  2. Collect and evaluate ocurrence of adverse events detected

    Time frame: from surgery to 12 months after IOL implantation

  3. PCO rate

    Time frame: 12 months after IOL implantation

  4. Nd-YAG capsulotomy rate

    Time frame: 12 months after IOL implantation

Sponsors and collaborators

Lead sponsor

Medicontur Medical Engineering Ltd

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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