NCT05895396

Brief Summary

This study is to compare the rotational stability, visual outcome and patient satisfaction after implantation with either Liberty 677MTY, a multifocal diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. (Zsámbék, Hungary) or the multifocal toric IOL PanOptix®, manufactured by Alcon.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2024

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

3.7 years

First QC Date

December 17, 2020

Last Update Submit

August 28, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Rotational stability

    Rotational stability will be measured using slit lamp images of the implanted lens

    Day 1

  • Rotational stability

    Rotational stability will be measured using slit lamp images of the implanted lens

    3 months

  • Rotational stability

    Rotational stability will be measured using slit lamp images of the implanted lens

    1 year

Secondary Outcomes (10)

  • Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)

    1 month

  • Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)

    3 months

  • Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)

    1 year

  • Contrast sensitivity defocus curve

    3 months

  • Contrast sensitivity defocus curve

    1 year

  • +5 more secondary outcomes

Other Outcomes (3)

  • Safety outcome - Intraoperative complications

    Day1 postoperatively

  • Safety outcome - Postoperative complications

    Month1 postoperatively

  • Safety outcome - Complications of IOL implantation

    Month 12 postoperatively

Study Arms (2)

Liberty

The group implanted with Liberty 677MTY

PanOptix

The group implanted with PanOptix

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cataract

You may qualify if:

  • The enrolled subjects will be the patients with cataract and pre-existing regular corneal astigmatism between 1.0 to 6.0 dpt.

You may not qualify if:

  • astigmatism less than 1 dpt
  • irregular astigmatism
  • diabetic retinopathy
  • iris neovascularisation
  • serious intraoperative complications
  • congenital eye abnormality
  • glaucoma
  • pseudoexfoliation syndrom
  • amblyopia
  • uveitis
  • long-term anti-inflammatory treatment
  • AMD (advanced AMD)
  • retinal detachment
  • prior ocular surgery in personal medical history
  • corneal diseases
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retinaszervíz

Veszprém, 8200, Hungary

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • József F Győry, MD

    Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 17, 2020

First Posted

June 8, 2023

Study Start

September 14, 2020

Primary Completion

May 10, 2024

Study Completion

May 10, 2024

Last Updated

August 30, 2024

Record last verified: 2024-08

Locations