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CompletedNCT05735990Updated Feb 21, 2023

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

An observational study in Cataract, Presbyopia and Hyperopia, sponsored by Medicontur Medical Engineering Ltd. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Medicontur Medical Engineering Ltd · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
21
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Cataract
  • Presbyopia
  • Hyperopia
  • Myopia
  • Pseudophakia
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's enrollment of 21 is below the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Medicontur Medical Engineering Ltd is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
21 participants (actual)
Patient registry
No

Groups and cohorts

  • 640PM implanted

    Patients implanted binocularly with Medicontur's intraocular lens model 640PM.

    Device: Intraocular lens

Interventions

  • DeviceIntraocular lens

    Aspheric hydrophilic acrylic IOL for implantation into the capsular bag

06

What researchers measure

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

07

Study locations

1 site
  • Hospital Vithas Almería
    Almería, 04120, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2022 to primary completion in Jan 2023, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2022
First posted
Feb 21, 2023
StartActual
Oct 27, 2022
Primary completionActual
Jan 31, 2023
CompletionActual
Jan 31, 2023
Last update
Feb 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05735990
Lead sponsor
Medicontur Medical Engineering Ltd
Responsible party
Sponsor
First posted
Feb 21, 2023
Start date
Oct 27, 2022
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023
Last update
Feb 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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