CataractMIOLReadNCT06978556
Photopic and Mesopic Multifocal IOL Performance
An observational study of Cataract and Presbyopia Correction, run by IROC AG at 1 site in Switzerland.
Trial summary
Modern cataract surgery has become a refractive procedure. Both, multifocal lens implantation and pseudophakic monovision with monofocal IOLs are effective means to address presbyopia correction after cataract surgery. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Presbyopia Correction
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2023to Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing cataract surgery with multifocal IOL implantation at the study site fulfilling inclusion criteria will be asked to participate in the study. All patients are referred by ophthalmologists or are self-referrals at the study site.
Who may be able to join
- Male and female subjects age 45 years of age and older
- Able to provide written informed consent and follow study instructions in English or German.
- Desire for spectacle independence
- Agreement on clinical decision for planned crystalline lens exchange with multifocal IOL implantation (Standardized femtosecond-laser capsulotomy (diameter 5.3mm))
- Willing and able to return for scheduled follow-up examinations;
Who cannot join
- Prior ophthalmic surgery or trauma
- Zonular-defects, unstable bag
- Macular pathologies
- Excessive irregular astigmatism
- 6. Pregnancy/lactation 7. Predicted Visual acuity of less than 0.8 decimal 8. Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Lens Position and Photopic and Mesopic Visual Acuity After Bilateral Implantation of Two Different Diffractive Multifocal Intraocular Lenses.
Modern cataract surgery has become a refractive procedure. Both, multifocal lens implantation and pseudophakic monovision with monofocal IOLs are effective means to address presbyopia correction after cataract surgery. Historically, diffractive multifocal IOLs have provided improved visual acuity at near and intermediate distances and a greater likelihood of spectacle independence than monofocal IOLs.
The light transmittance ratio of the crystalline lens is high and as a monofocal ocular medium that has the ability to modify its shape and geometric properties according to the focal point. Therefore, it is capable of delivering the exact same light energy to the retina, regardless of the distance of the object. Trifocal IOL designs split the light in three focal points. By varying the height of the diffractive step, the amount of light distributed to near, intermediate and distant foci is adjusted according to pupil aperture. The distribution of light to three different foci includes several potential disadvantages, such as loss of visual acuity in mesopic conditions and a loss of contrast sensitivity. Thus, the visual performance of multifocal IOLs depends on several factors, the addition (add) power is a major determinant of the actual range of clear vision, another factor is the light transmittance characteristics of the lens (e.g., the incorporation of a blue light filter).
Read more
As different trifocal IOLs become available, it is important to have information on their characteristics regarding visual acuity in order to be able to recommend an IOL that meets the individualized needs of each patient. In order to provide the patient with a high visual acuity in all promised distances, these IOLs need to be aimed at and achieve emmetropia.
Furthermore, multifocal IOLs need good capsular bag centration, they need to remain as unaffected as possible by capsular bag constriction and remain stable in their axial lens position in order to provide a stable refraction after surgery.
The investigators compare the anterior chamber depth stability as marker for positional stability and haptic buckling between two different diffractive IOL designs, one with C-loop haptics and one with plate haptics. Furthermore, the refractive outcome of these IOLs with different designs is examined in photopic and mesopic conditions, as well as visual acuity results for both IOLs.
- Conditions
- Cataract, Presbyopia Correction
- Being tested
- No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated.
- Keywords
- Cataract, multifocal iol, presbyopia, reading speed
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated.Diagnostic test
No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated. Including data from testing refraction, visual acuity, biometry, tomography, and OCT.
| Study group | Role | What they receive |
|---|---|---|
| Multifocal IOL 1 | bilateral pseudophakia with multifocal IOL 1 (Johnson and Johnson Synergy) Receives: Diagnostic Test: No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated. | |
| Multifocal IOL 2 | bilateral pseudophakia with multifocal IOL 2 (Carl Zeiss Meditec AT Lisa Tri) Receives: Diagnostic Test: No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL axial position stability
as measured with a biometry and/or anterior segment device.
Measured: 1, 3, 6, 12 months
Secondary outcomes (3)
refraction
standardized ETDRS charts Optometrist blinded
Measured: 1, 3, 6, 12 months
Visual acuity
Standardized with ETDRS charts for far, intermediate, and far distance visual acuity. Defocus curve.
Optometris is blinded. Measurement in photopic and mesopic conditions
Measured: 1, 3, 6, 12 months
Reading speed
standardized with iRest test. In photopic and mesopic conditions.
optometrist is blinded.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jan 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IROC AG
- Sponsor type
- University, hospital or other
- Collaborators
- AMO Ireland
- Responsible party
- Principal investigator, Theo Seiler, IROC AG
- Investigators
- Theo Seiler, MD, Principal investigator, IROC AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978556
- Sponsor's protocol ID
- EMEA202102
- Other IDs
- IE9970584V
- Acronym
- MIOLRead
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only upon reasonable request
Publications
Benyoussef AA, Reboux N, Cochener B. Comparison of Bilateral Reading Performance Among Two Presbyopia-Correcting Intraocular Lenses. J Refract Surg. 2022 Jul;38(7):428-434. doi: 10.3928/1081597X-20220516-02. Epub 2022 Jul 1.
PubMed 35858191Seiler TG, Wegner A, Senfft T, Seiler T. Dissatisfaction After Trifocal IOL Implantation and Its Improvement by Selective Wavefront-Guided LASIK. J Refract Surg. 2019 Jun 1;35(6):346-352. doi: 10.3928/1081597X-20190510-02.
PubMed 31185099Cillino G, Casuccio A, Pasti M, Bono V, Mencucci R, Cillino S. Working-age cataract patients: visual results, reading performance, and quality of life with three diffractive multifocal intraocular lenses. Ophthalmology. 2014 Jan;121(1):34-44. doi: 10.1016/j.ophtha.2013.06.034. Epub 2013 Aug 14.
PubMed 23953097Marques EF, Ferreira TB. Comparison of visual outcomes of 2 diffractive trifocal intraocular lenses. J Cataract Refract Surg. 2015 Feb;41(2):354-63. doi: 10.1016/j.jcrs.2014.05.048.
PubMed 25661129Martinez-de-la-Casa JM, Carballo-Alvarez J, Garcia-Bella J, Vazquez-Molini JM, Morales L, Sanz-Fernandez JC, Polo V, Garcia-Feijoo J. Photopic and Mesopic Performance of 2 Different Trifocal Diffractive Intraocular Lenses. Eur J Ophthalmol. 2017 Jan/Feb;27(1):26-30. doi: 10.5301/ejo.5000814.
PubMed 27375069Alio JL, Kaymak H, Breyer D, Cochener B, Plaza-Puche AB. Quality of life related variables measured for three multifocal diffractive intraocular lenses: a prospective randomised clinical trial. Clin Exp Ophthalmol. 2018 May;46(4):380-388. doi: 10.1111/ceo.13084. Epub 2017 Nov 29.
PubMed 29044974Portney V. Light distribution in diffractive multifocal optics and its optimization. J Cataract Refract Surg. 2011 Nov;37(11):2053-9. doi: 10.1016/j.jcrs.2011.04.038.
PubMed 22018367Hienert J, Hirnschall N, Ruiss M, Ullrich M, Zwickl H, Findl O. Prospective study to compare axial position stability after fellow-eye implantation of 2 distinct intraocular lens designs. J Cataract Refract Surg. 2021 Aug 1;47(8):999-1005. doi: 10.1097/j.jcrs.0000000000000557.
PubMed 33577276
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lens Position and Photopic and Mesopic Visual Acuity After Bilateral Implantation of Two Different Diffractive Multifocal Intraocular Lenses.
- ClinicalTrials.gov ID
- NCT06978556
- Acronym / sponsor ID
- MIOLRead / EMEA202102
- Conditions
- Cataract, Presbyopia Correction
- Keywords
- Cataract, multifocal iol, presbyopia, reading speed
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IROC AGUniversity, hospital or other
- Collaborators
- AMO Ireland
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 May 2025 (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.
Modern cataract surgery has become a refractive procedure. Both, multifocal lens implantation and pseudophakic monovision with monofocal IOLs are effective means to address presbyopia correction after cataract surgery. Historically, diffractive multifocal IOLs have provided improved visual acuity at near and intermediate distances and a greater likelihood of spectacle independence than monofocal IOLs.
The light transmittance ratio of the crystalline lens is high and as a monofocal ocular medium that has the ability to modify its shape and geometric properties according to the focal point. Therefore, it is capable of delivering the exact same light energy to the retina, regardless of the distance of the object. Trifocal IOL designs split the light in three focal points. By varying the height of the diffractive step, the amount of light distributed to near, intermediate and distant foci is adjusted according to pupil aperture. The distribution of light to three different foci includes several potential disadvantages, such as loss of visual acuity in mesopic conditions and a loss of contrast sensitivity. Thus, the visual performance of multifocal IOLs depends on several factors, the addition (add) power is a major determinant of the actual range of clear vision, another factor is the light transmittance characteristics of the lens (e.g., the incorporation of a blue light filter).
As different trifocal IOLs become available, it is important to have information on their characteristics regarding visual acuity in order to be able to recommend an IOL that meets the individualized needs of each patient. In order to provide the patient with a high visual acuity in all promised distances, these IOLs need to be aimed at and achieve emmetropia.
Furthermore, multifocal IOLs need good capsular bag centration, they need to remain as unaffected as possible by capsular bag constriction and remain stable in their axial lens position in order to provide a stable refraction after surgery.
The investigators compare the anterior chamber depth stability as marker for positional stability and haptic buckling between two different diffractive IOL designs, one with C-loop haptics and one with plate haptics. Furthermore, the refractive outcome of these IOLs with different designs is examined in photopic and mesopic conditions, as well as visual acuity results for both IOLs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifocal IOL 1 | – | Diagnostic Test: No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated.bilateral pseudophakia with multifocal IOL 1 (Johnson and Johnson Synergy) |
| Multifocal IOL 2 | – | Diagnostic Test: No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated.bilateral pseudophakia with multifocal IOL 2 (Carl Zeiss Meditec AT Lisa Tri) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing cataract surgery with multifocal IOL implantation at the study site fulfilling inclusion criteria will be asked to participate in the study. All patients are referred by ophthalmologists or are self-referrals at the study site.
Key inclusion criteria (5 listed)
- Male and female subjects age 45 years of age and older
- Able to provide written informed consent and follow study instructions in English or German.
- Desire for spectacle independence
- Agreement on clinical decision for planned crystalline lens exchange with multifocal IOL implantation (Standardized femtosecond-laser capsulotomy (diameter 5.3mm))
- Willing and able to return for scheduled follow-up examinations;
Key exclusion criteria (5 listed)
- Prior ophthalmic surgery or trauma
- Zonular-defects, unstable bag
- Macular pathologies
- Excessive irregular astigmatism
- 6. Pregnancy/lactation 7. Predicted Visual acuity of less than 0.8 decimal 8. Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
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 |
|---|---|---|
| No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated.No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated. Including data from testing refraction, visual acuity, biometry, tomography, and OCT. | Diagnostic test | Multifocal IOL 1, Multifocal IOL 2 |
Primary outcome
IOL axial position stability
Time frame: 1, 3, 6, 12 months
as measured with a biometry and/or anterior segment device.
3 secondary outcomes
refraction
Time frame: 1, 3, 6, 12 months
Visual acuity
Time frame: 1, 3, 6, 12 months
Reading speed
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Background: PubMed 35858191Benyoussef AA, Reboux N, Cochener B. Comparison of Bilateral Reading Performance Among Two Presbyopia-Correcting Intraocular Lenses. J Refract Surg. 2022 Jul;38(7):428-434. doi: 10.3928/1081597X-20220516-02. Epub 2022 Jul 1.
- Background: PubMed 31185099Seiler TG, Wegner A, Senfft T, Seiler T. Dissatisfaction After Trifocal IOL Implantation and Its Improvement by Selective Wavefront-Guided LASIK. J Refract Surg. 2019 Jun 1;35(6):346-352. doi: 10.3928/1081597X-20190510-02.
- Background: PubMed 23953097Cillino G, Casuccio A, Pasti M, Bono V, Mencucci R, Cillino S. Working-age cataract patients: visual results, reading performance, and quality of life with three diffractive multifocal intraocular lenses. Ophthalmology. 2014 Jan;121(1):34-44. doi: 10.1016/j.ophtha.2013.06.034. Epub 2013 Aug 14.
- Background: PubMed 25661129Marques EF, Ferreira TB. Comparison of visual outcomes of 2 diffractive trifocal intraocular lenses. J Cataract Refract Surg. 2015 Feb;41(2):354-63. doi: 10.1016/j.jcrs.2014.05.048.
- Background: PubMed 27375069Martinez-de-la-Casa JM, Carballo-Alvarez J, Garcia-Bella J, Vazquez-Molini JM, Morales L, Sanz-Fernandez JC, Polo V, Garcia-Feijoo J. Photopic and Mesopic Performance of 2 Different Trifocal Diffractive Intraocular Lenses. Eur J Ophthalmol. 2017 Jan/Feb;27(1):26-30. doi: 10.5301/ejo.5000814.
- Background: PubMed 29044974Alio JL, Kaymak H, Breyer D, Cochener B, Plaza-Puche AB. Quality of life related variables measured for three multifocal diffractive intraocular lenses: a prospective randomised clinical trial. Clin Exp Ophthalmol. 2018 May;46(4):380-388. doi: 10.1111/ceo.13084. Epub 2017 Nov 29.
- Background: PubMed 22018367Portney V. Light distribution in diffractive multifocal optics and its optimization. J Cataract Refract Surg. 2011 Nov;37(11):2053-9. doi: 10.1016/j.jcrs.2011.04.038.
- Background: PubMed 33577276Hienert J, Hirnschall N, Ruiss M, Ullrich M, Zwickl H, Findl O. Prospective study to compare axial position stability after fellow-eye implantation of 2 distinct intraocular lens designs. J Cataract Refract Surg. 2021 Aug 1;47(8):999-1005. doi: 10.1097/j.jcrs.0000000000000557.
- Individual participant dataSharing planned: No. Only upon reasonable request
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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.
Theo Seiler, MD principal investigator
IROC AG
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 and Presbyopia Correction, run by IROC AG at 1 site in Switzerland.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
IOL axial position stability (time frame: 1, 3, 6, 12 months). 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 NCT06978556, which also lists 8 linked publications.
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 21 May 2025.