NCT04670237

Brief Summary

The purpose of this study is to evaluate visual outcomes, patient satisfaction and YAG capsulotomy rate after implantation of a multifocal toric lens- Liberty 677MTY - manufactured by Medicontur Ltd. (Zsámbék, Hungary),

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

4.1 years

First QC Date

December 10, 2020

Last Update Submit

May 31, 2023

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Rotational stability

    Rotational stability will be measured using slit lamp images of the implanted lens on day one, seven, month one, three and one year postoperatively

    1 year

Secondary Outcomes (4)

  • Visual outcome

    1 year

  • Contrast sensitivity

    1 year

  • YAG capsulatomy

    1 year

  • Patient satisfaction

    1 year

Interventions

Liberty677MTY Multifocal Toric IOLDEVICE

multifocal, toric intraocular lens (IOL)

Eligibility Criteria

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

The enrolled subjects will be the patients with cataract and pre-existing regular corneal astigmatism between 1.0 to 6.0 dpt. (Cylindric power of IOLs will range between 1.0 to 6.0 dpts). The patients will be indicated for cataract surgery and toric IOL implantation by the clinical investigator. The study will be conducted according to the tenets of the Declaration of Helsinki and patients will give informed consent after the nature and intent of study will be fully explained to them.

You may not qualify if:

  • astigmatism less than 1 dpt
  • irregural 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)

Semmelweis University, Department of Ophthalmology

Budapest, H-1085, Hungary

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

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

Study Record Dates

First Submitted

December 10, 2020

First Posted

December 17, 2020

Study Start

December 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations

HU(1)