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CataractNCT04670237

Clinical Outcome After Implantation of Medicontur Liberty 677MTY, a Multifocal, Toric IOL

An observational study of Cataract, run by Medicontur Medical Engineering Ltd at 1 site in Hungary.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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), Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract
What is being tested?
Liberty677MTY Multifocal Toric IOL
Type of treatment
Medical device
How many people
30 participants
Where
1 siteHungary
Study dates
1 Dec 2019to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • -

Who cannot join

  • astigmatism less than 1 dpt
  • irregural astigmatism
  • diabetic retinopathy
  • iris neovascularisation
  • serious intraoperative complications
  • congenital eye abnormality
Show all 24Show fewer
  • glaucoma
  • pseudoexfoliation syndrom
  • amblyopia
  • uveitis
  • long-term anti-inflammatory treatment
  • AMD (advanced AMD)
  • retinal detachment
  • prior ocular surgery in personal medical history
  • corneal diseases
  • severe retinal diseases (dystrophy, degeneration)
  • severe myopia (if required IOL power is lower than 10 D)
  • inadequate visualization of the fundus on preoperative examination
  • patients deemed by the clinical investigator because of any systemic disease.
  • eye trauma in medical history intraoperative exclusions:
  • tear in capsulorhexis
  • zonular dehiscence
  • posterior capsular rupture
  • vitreous loss and other unexpected surgical complication

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • Semmelweis University, Department of Ophthalmology

    Budapest, H-1085

Other trials in Hungary

About this study

Official title: Clinical Outcome After Implantation of Medicontur Multifocal, Toric Intraocular Lens Liberty 677MTY: Rotational Stability, Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate

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),

Read the detailed description

The purpose of this study is to evaluate visual outcomes, glass independency, visual disturbances (glares, halos), neuronal adaptation and patient satisfaction after implantation of multifocal diffractive apodized toric intraocular lens- Liberty 677MTY - diffractive-refractive apodized IOL based on EPS technology manufactured by Medicontur Ltd. (Zsámbék, Hungary).

The tested IOL model, Liberty 677MTY, has an overall length of 13 mm, an optic diameter of 6.0 mm without haptics angulations but with posterior vaulting. The refractive index of the optic material is 1.46 (at 23°C). The IOL is a single-piece-IOL, the optic and haptics are made from a hydrophilic acrylic co-polymer with integrated - covalently bound UV absorbent. The IOL is produced with yellow filter, covalently bound yellow chromophore. The toric component of Liberty 677MTY IOL is located on the posterior surface of the lens optic. The optic is marked with 2 marks. The marks are positioned exactly in middle between the two loops of haptic at the angulation at the flat axis of toric equivalent. The Liberty 677MTY is available with cylinder powers of 1.0 diopter (D) to 6.0 D. The IOL is designed with sharp edge following 360º to prevent migration of the lens epithelial cells , thereby to prevent PCO formation.

The trifocality of the lens is provided by the EPS technology recently developed by Medicontur uses an elevated phase shift on the central diffractive part of the lens in order to cause constructive interference between the 0th (far) and 1st diffractive (near) order, thus creating a 3rd (intermediate) focal point.

Conditions
Cataract
Being tested
Liberty677MTY Multifocal Toric IOL
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liberty677MTY Multifocal Toric IOLDevice

    multifocal, toric intraocular lens (IOL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (4)

  1. Visual outcome

    Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart at month one, three and one year postoperatively

    Measured: 1 year

  2. Contrast sensitivity

    Contrast sensitivity will be assessed by using the CSV-1000 method in photopic and mesopic light condition three month and one year after implantation

    Measured: 1 year

  3. YAG capsulatomy

    The rate of YAG capsulatomy will be assessed during the one year follow-up

    Measured: 1 year

  4. Patient satisfaction

    Patient satisfaction will be assessed by using the VFQ-25 questionnaire three month and one year postoperatively

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start1 Dec 2019
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04670237
Sponsor's protocol ID
MC_Liberty677MTY_HU_2019
Status last verified
May 2023
First submitted
10 Dec 2020
Last updated
1 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract, run by Medicontur Medical Engineering Ltd at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rotational stability (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04670237.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.

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