Intraocular LensNCT05041881
Long-term Comparative Analysis of Visual Outcomes With 3 Intraocular Lenses: Monofocal, Trifocal and Accommodating
A study testing Trifocal lens AT LISA TRI, Zeiss, Accommodating Tetraflex HD lens, Lenstec inc. and Monofocal lens, Softec HD in people with Intraocular Lens, run by Faculty Hospital Kralovske Vinohrady at 2 sites in 2 countries.
Trial summary
To compare visual outcomes, contrast sensitivity, glare occurrence, incidence of posterior capsule opacification (PCO) and subjective satisfaction in patients implanted with trifocal, accommodating and monofocal lens in long term period. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Lens
- What is being tested?
- Trifocal lens AT LISA TRI, Zeiss, Accommodating Tetraflex HD lens, Lenstec inc. and Monofocal lens, Softec HD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2020to 1 Jun 2022
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- phacoemulsification with one of the 3 types of lens implantation before 36 to 48months
- no other ocular pathology affecting visual acuity
- able to maintain follow up visit
Who cannot join
- corneal opacities or irregularities
- amblyopia
- glaucoma with change in visual fields
- any other type of ocular surgery than phacoemulsification with primary lens implantation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Czechia1 site, 1 recruiting
- Recruiting
Eye Center Prague
Prague, Czech Republic, 11000
Andrea Janekova, MD, +420775727002, janekovaandrea@gmail.com
Slovakia1 site, 1 recruiting
- Recruiting
Eye Center Sokolik
Trenčín, 91101
Andrea Janekova, MD, +420775727002, janekovaandrea@gmail.com
About this study
Official title: Long-term Comparative Analysis of Visual Outcomes and Patients Satisfaction With 3 Intraocular Lenses: Trifocal, Accommodating and Monofocal
To compare visual outcomes, contrast sensitivity, glare occurrence, incidence of posterior capsule opacification (PCO) and subjective satisfaction in patients implanted with trifocal, accommodating and monofocal lens in long term period.
Read the detailed description
The goal of cataract surgery is to remove lens opacity and restore vision. Nowadays most of the patients wanted to be spectacle independent. The desire of visual acuity for all distances increases the popularity of multifocal and trifocal lenses. As these type of lenses are mostly based on diffractive structure, there could be occurrence of unwanted optical phenomena and lower contrast sensitivity. The effort is to produce intraocular lens (IOL) with good vision for all distances without these unwanted effects. Increasing daily task for intermediate distance led to the new category of IOLs- EDOF( extended depth of focus) IOLS, which are based mostly on diffractive profiles too, but should have less optical phenomena occurrence. To completely remove glare, halo and retain standard good contrast sensitivity enhance monofocal lenses were invented, mostly based on spherical aberrations, but not achieving as good intermediate vision as multifocal or EDOF lenses do. Accommodating lenses should provide better intermediate distance without unwanted optical effects on vision.
This study is retro-prospective, comparing 3 different lenses in long-term period. First group includes patients with trifocal lens allowing patients to see for all distances, second group includes patients with implanted accommodating lens which allows good distance and better intermediate distance than monofocal. Third group include patients with standard monofocal lens. Preoperative data were collected retrospectively and one prospective visit was scheduled in period 36- 48 months after the surgery. Study is conducted in 2 eye centers- one in Slovakia Trenčín, one in Prague, Czech Republic. The study was approved by the Ethic committee of faculty hospital Hradec Kralove (202103 P08). and will enrolled up 40 patients in each category.
- Conditions
- Intraocular Lens
- Being tested
- Trifocal lens AT LISA TRI, Zeiss, Accommodating Tetraflex HD lens, Lenstec inc., Monofocal lens, Softec HD
- Keywords
- trifocal lens, accommodating lens, monofocal lens, optical phenomena, glare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifocal lens AT LISA TRI, ZeissDevice
lens is made of hydrophilic acrylic material with square edge technology and having diffractive optic design
Accommodating Tetraflex HD lens, Lenstec inc.Device
lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design
Monofocal lens, Softec HDDevice
lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design
| Study group | Role | What they receive |
|---|---|---|
| Trifocal IOL group | Active comparator | Patients implanted during cataract or refractive surgery with trifocal lens, which allowed to see for far, intermediate and near distance, but due to optic design having unwanted effect like optical phenomena and lower contrast sensitivity Receives: Device: Trifocal lens AT LISA TRI, Zeiss |
| Accommodating IOL group | Active comparator | Patients implanted during cataract or refractive surgery with accommodating lens, which allowed to see for far and should improve intermediate distance better than monofocal lens do. Receives: Device: Accommodating Tetraflex HD lens, Lenstec inc. |
| Monofocal IOL group | Active comparator | Patients implanted during cataract or refractive surgery with standard monofocal lens, which allowed to see for far but patients do not experiences optical phenomena or low contrast sensitivity. Receives: Device: Monofocal lens, Softec HD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of visual acuity for distance between groups
uncorrected distance visual acuity (UDVA) corrected distance visual acuity (CDVA)
Measured: 36-48 months after surgery
Comparison of visual acuity for intermediate between groups
Uncorrected intermediate visual acuity (UIVA) Distance corrected intermediate visual acuity (DCIVA)
Measured: 36-48 months after surgery
Comparison of near visual acuity between group 1 (trifocal lens) and group 2 (accommodating lens)
uncorrected near visual acuity (UNVA)
Measured: 36-48 months after surgery
Contrast sensitivity comparison between groups
Photopic contrast sensitivity with glare Mesopic contrast sensitivity with glare Mesopic contrast sensitivity without glare
Measured: 36-48 months after surgery
Incidence of posterior capsule opacification (PCO)
Incidence of PCO and needed Nd YAG capsulotomy treatment in each group
Measured: 36-48 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Sep 2020
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular LensStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- each group consist of patient receiving one type of intraocular lens- trifocal, accommodating or monofocal
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Andrea Janekova, Faculty Hospital Kralovske Vinohrady
- Investigators
- Andrea Janekova, MD, Principal investigator, Faculty Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041881
- Sponsor's protocol ID
- TRIMACO
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Comparative Analysis of Visual Outcomes and Patients Satisfaction With 3 Intraocular Lenses: Trifocal, Accommodating and Monofocal
- ClinicalTrials.gov ID
- NCT05041881
- Acronym / sponsor ID
- TRIMACO
- Conditions
- Intraocular Lens
- Keywords
- trifocal lens, accommodating lens, monofocal lens, optical phenomena, glare
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 13 Sep 2021 (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.
To compare visual outcomes, contrast sensitivity, glare occurrence, incidence of posterior capsule opacification (PCO) and subjective satisfaction in patients implanted with trifocal, accommodating and monofocal lens in long term period.
Detailed description
The goal of cataract surgery is to remove lens opacity and restore vision. Nowadays most of the patients wanted to be spectacle independent. The desire of visual acuity for all distances increases the popularity of multifocal and trifocal lenses. As these type of lenses are mostly based on diffractive structure, there could be occurrence of unwanted optical phenomena and lower contrast sensitivity. The effort is to produce intraocular lens (IOL) with good vision for all distances without these unwanted effects. Increasing daily task for intermediate distance led to the new category of IOLs- EDOF( extended depth of focus) IOLS, which are based mostly on diffractive profiles too, but should have less optical phenomena occurrence. To completely remove glare, halo and retain standard good contrast sensitivity enhance monofocal lenses were invented, mostly based on spherical aberrations, but not achieving as good intermediate vision as multifocal or EDOF lenses do. Accommodating lenses should provide better intermediate distance without unwanted optical effects on vision.
This study is retro-prospective, comparing 3 different lenses in long-term period. First group includes patients with trifocal lens allowing patients to see for all distances, second group includes patients with implanted accommodating lens which allows good distance and better intermediate distance than monofocal. Third group include patients with standard monofocal lens. Preoperative data were collected retrospectively and one prospective visit was scheduled in period 36- 48 months after the surgery. Study is conducted in 2 eye centers- one in Slovakia Trenčín, one in Prague, Czech Republic. The study was approved by the Ethic committee of faculty hospital Hradec Kralove (202103 P08). and will enrolled up 40 patients in each category.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- each group consist of patient receiving one type of intraocular lens- trifocal, accommodating or monofocal
| Arm | Type | Receives |
|---|---|---|
| Trifocal IOL group | Active comparator | Device: Trifocal lens AT LISA TRI, ZeissPatients implanted during cataract or refractive surgery with trifocal lens, which allowed to see for far, intermediate and near distance, but due to optic design having unwanted effect like optical phenomena and lower contrast sensitivity |
| Accommodating IOL group | Active comparator | Device: Accommodating Tetraflex HD lens, Lenstec inc.Patients implanted during cataract or refractive surgery with accommodating lens, which allowed to see for far and should improve intermediate distance better than monofocal lens do. |
| Monofocal IOL group | Active comparator | Device: Monofocal lens, Softec HDPatients implanted during cataract or refractive surgery with standard monofocal lens, which allowed to see for far but patients do not experiences optical phenomena or low contrast sensitivity. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- phacoemulsification with one of the 3 types of lens implantation before 36 to 48months
- no other ocular pathology affecting visual acuity
- able to maintain follow up visit
Key exclusion criteria (4 listed)
- corneal opacities or irregularities
- amblyopia
- glaucoma with change in visual fields
- any other type of ocular surgery than phacoemulsification with primary lens implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trifocal lens AT LISA TRI, Zeisslens is made of hydrophilic acrylic material with square edge technology and having diffractive optic design | Device | Trifocal IOL group |
| Accommodating Tetraflex HD lens, Lenstec inc.lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design | Device | Accommodating IOL group |
| Monofocal lens, Softec HDlens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design | Device | Monofocal IOL group |
Primary outcome
Comparison of visual acuity for distance between groups
Time frame: 36-48 months after surgery
uncorrected distance visual acuity (UDVA) corrected distance visual acuity (CDVA)
Comparison of visual acuity for intermediate between groups
Time frame: 36-48 months after surgery
Uncorrected intermediate visual acuity (UIVA) Distance corrected intermediate visual acuity (DCIVA)
Comparison of near visual acuity between group 1 (trifocal lens) and group 2 (accommodating lens)
Time frame: 36-48 months after surgery
uncorrected near visual acuity (UNVA)
Contrast sensitivity comparison between groups
Time frame: 36-48 months after surgery
Photopic contrast sensitivity with glare Mesopic contrast sensitivity with glare Mesopic contrast sensitivity without glare
Incidence of posterior capsule opacification (PCO)
Time frame: 36-48 months after surgery
Incidence of PCO and needed Nd YAG capsulotomy treatment in each group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
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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.
Andrea Janekova, MD principal investigator
Faculty Hospital Kralovske Vinohrady
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trifocal lens AT LISA TRI, Zeiss, Accommodating Tetraflex HD lens, Lenstec inc. and Monofocal lens, Softec HD in people with Intraocular Lens, run by Faculty Hospital Kralovske Vinohrady at 2 sites in 2 countries.
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 3 inclusion and 4 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 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Slovakia. 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?
Contact Andrea Janekova, MD (+420775727002, janekovaandrea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of visual acuity for distance between groups (time frame: 36-48 months after surgery). The study lists 5 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 1 Oct 2021; AzTrials last refreshed its copy on 1 Nov 2026.