NCT05735990

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

October 28, 2022

Last Update Submit

February 9, 2023

Conditions

CataractPresbyopiaHyperopiaMyopiaPseudophakia

Outcome Measures

Primary Outcomes (1)

  • Corrected distance visual acuity (CDVA);

    12 months after IOL implantation

Secondary Outcomes (9)

  • 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;

  • +4 more secondary outcomes

Other Outcomes (4)

  • Secondary surgical intervention rate

    12 months after IOL implantation;

  • Collect and evaluate ocurrence of adverse events detected

    from surgery to 12 months after IOL implantation

  • PCO rate

    12 months after IOL implantation

  • +1 more other outcomes

Study Arms (1)

640PM implanted

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

Device: Intraocular lens

Interventions

Intraocular lensDEVICE

Aspheric hydrophilic acrylic IOL for implantation into the capsular bag

640PM implanted

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vithas Almería

Almería, 04120, Spain

Location

Related Publications (1)

  • Fernandez J, Srinivasan S, Burguera N, Martinez J, Rodriguez-Vallejo M. One-year follow-up of a multifocal intraocular lens with optimized elevated phase shift. J Cataract Refract Surg. 2023 Oct 1;49(10):1018-1024. doi: 10.1097/j.jcrs.0000000000001266.

    PMID: 37464551DERIVED

MeSH Terms

Conditions

CataractPresbyopiaHyperopiaMyopiaPseudophakia

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive ErrorsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2022

First Posted

February 21, 2023

Study Start

October 27, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)