CataractNCT05895396
Clinical Outcome After Implantation of Two Different Multifocal Toric IOLs: Liberty (677MTY) and PanOptix®
An observational study of Cataract, run by Medicontur Medical Engineering Ltd at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- How many people
- 35 participants
- Where
- 1 siteHungary
- Study dates
- 14 Sep 2020to 10 May 2024
- 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
- Adult, Older adult
Study population: Patients with cataract
Who may be able to join
- The enrolled subjects will be the patients with cataract and pre-existing regular corneal astigmatism between 1.0 to 6.0 dpt.
Who cannot join
- astigmatism less than 1 dpt
- irregular 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.
About this study
Official title: Comparison of Clinical Outcome After Implantation With Two Different Multifocal Toric Intraocular Lens: Liberty Trifocal 677MTY (Medicontur) and PanOptix® Multifocal Toric (Alcon) Lens, With Respect to Rotational Stability, Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate
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.
Read the detailed description
According to numerous estimations, 15% to 29% of patients with cataract have more than 1.5 diopters of refractive astigmatism. Corneal astigmatism can be reduced with a variety of surgical techniques including selective positioning of the phacoemulsification incision, corneal relaxing incision, implantation of toric IOLs, photorefractive keratectomy and there are first results of implantation of short arc-length intrastromal corneal ring segments for correcting astigmatism and myopia . The use of toric IOLs to reduce visually significant keratometric astigmatism offers a rational, more predictable and stable method of refractive correction. Implanting a toric intraocular lens offers the possibility of correcting not only spherical equivalent of refraction, but also astigmatism. The success of a toric IOL can be judged not only by its ability to reduce refractive astigmatism immediately postoperatively, but also by its ability to maintain a stable position in the capsular bag in the longer term. Even a small rotational deviation of the toric IOL from its intended axis can result in large reduction of the astigmatic correction.
The purpose of this study is to evaluate and compare the visual outcomes, spectacle independency, visual disturbances (glares, halos), neuronal adaptation and patient satisfaction after implantation of either the Liberty 677MTY (a multifocal diffractive apodized toric intraocular lens- diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. Zsámbék, Hungary) or the multifocal toric PanOptix® IOL, manufactured by Alcon.
- Conditions
- Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liberty | The group implanted with Liberty 677MTY | |
| PanOptix | The group implanted with PanOptix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotational stability
Rotational stability will be measured using slit lamp images of the implanted lens
Measured: Day 1
Rotational stability
Rotational stability will be measured using slit lamp images of the implanted lens
Measured: 3 months
Rotational stability
Rotational stability will be measured using slit lamp images of the implanted lens
Measured: 1 year
Secondary outcomes (10)
Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)
Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart.
Measured: 1 month
Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)
Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart
Measured: 3 months
Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)
Monocular and binocular visual aquity will be measured at far, intermediate and near distances by standard ETDRS chart
Measured: 1 year
Contrast sensitivity defocus curve
Contrast sensitivity defocus curve will be assessed using the Multifocal Lense Analyser iPAD application.
Measured: 3 months
Contrast sensitivity defocus curve
Contrast sensitivity defocus curve will be assessed using the Multifocal Lense Analyser iPAD application.
Measured: 1 year
Contrast sensitivity
Contrast sensitivity in photopic and mesopic light conditions with or without glare will be assessed one year postoperatively using CSV-1000
Measured: 1 year
Multifocality (Visual Acuity Defocus Curve)
The multifocality of the lens will be evaluated also by monocular and binocular visual acuity defocus curves (VADC) using the multifocal lens analyser iPAD application
Measured: 3 months
Multifocality (Visual Acuity Defocus Curve)
The multifocality of the lens will be evaluated also by monocular and binocular visual acuity defocus curves using the multifocal lens analyser iPAD application.
Measured: 1 year
Patient satisfaction
Patient satisfaction will be measures with the VFQ-14 questionnaire
Measured: 3 months
Patient satisfaction
Patient satisfaction will be measures with the VFQ-14 questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start14 Sep 2020
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicontur Medical Engineering Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- József F Győry, MD, Principal investigator, Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895396
- Sponsor's protocol ID
- 677MTY _PanOptix_HU_2020
- Status last verified
- Aug 2024
- First submitted
- 17 Dec 2020
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcome After Implantation With Two Different Multifocal Toric Intraocular Lens: Liberty Trifocal 677MTY (Medicontur) and PanOptix® Multifocal Toric (Alcon) Lens, With Respect to Rotational Stability, Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate
- ClinicalTrials.gov ID
- NCT05895396
- Acronym / sponsor ID
- 677MTY _PanOptix_HU_2020
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Medicontur Medical Engineering LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
According to numerous estimations, 15% to 29% of patients with cataract have more than 1.5 diopters of refractive astigmatism. Corneal astigmatism can be reduced with a variety of surgical techniques including selective positioning of the phacoemulsification incision, corneal relaxing incision, implantation of toric IOLs, photorefractive keratectomy and there are first results of implantation of short arc-length intrastromal corneal ring segments for correcting astigmatism and myopia . The use of toric IOLs to reduce visually significant keratometric astigmatism offers a rational, more predictable and stable method of refractive correction. Implanting a toric intraocular lens offers the possibility of correcting not only spherical equivalent of refraction, but also astigmatism. The success of a toric IOL can be judged not only by its ability to reduce refractive astigmatism immediately postoperatively, but also by its ability to maintain a stable position in the capsular bag in the longer term. Even a small rotational deviation of the toric IOL from its intended axis can result in large reduction of the astigmatic correction.
The purpose of this study is to evaluate and compare the visual outcomes, spectacle independency, visual disturbances (glares, halos), neuronal adaptation and patient satisfaction after implantation of either the Liberty 677MTY (a multifocal diffractive apodized toric intraocular lens- diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. Zsámbék, Hungary) or the multifocal toric PanOptix® IOL, manufactured by Alcon.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberty | – | –The group implanted with Liberty 677MTY |
| PanOptix | – | –The group implanted with PanOptix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with cataract
Key inclusion criteria (1 listed)
- The enrolled subjects will be the patients with cataract and pre-existing regular corneal astigmatism between 1.0 to 6.0 dpt.
Key exclusion criteria (24 listed)
- astigmatism less than 1 dpt
- irregular astigmatism
- diabetic retinopathy
- iris neovascularisation
- serious intraoperative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rotational stability
Time frame: Day 1
Rotational stability will be measured using slit lamp images of the implanted lens
Rotational stability
Time frame: 3 months
Rotational stability will be measured using slit lamp images of the implanted lens
Rotational stability
Time frame: 1 year
Rotational stability will be measured using slit lamp images of the implanted lens
10 secondary outcomes
Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)
Time frame: 1 month
Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)
Time frame: 3 months
Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)
Time frame: 1 year
Contrast sensitivity defocus curve
Time frame: 3 months
Contrast sensitivity defocus curve
Time frame: 1 year
Contrast sensitivity
Time frame: 1 year
Multifocality (Visual Acuity Defocus Curve)
Time frame: 3 months
Multifocality (Visual Acuity Defocus Curve)
Time frame: 1 year
Patient satisfaction
Time frame: 3 months
Patient satisfaction
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
József F Győry, MD principal investigator
Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary)
1 site in 1 country: see every site and its status.
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: finished, as of the sponsor's last update on 30 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2024.