CataractNCT05462067
Combined EDOF / Trifocal
A study testing AT LARA IOL and AT LISA Tri IOL in people with Cataract, run by Carl Zeiss Meditec AG at 4 sites in 3 countries.
Trial summary
The purpose of this study is to obtain postoperative visual performance data of patients with bilateral implantation of the AT LARA IOL or the AT LARA implanted in the dominant eye and AT LISA tri implanted in the other eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- AT LARA IOL and AT LISA Tri IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 14 Mar 2019to 20 Nov 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients bilaterally implanted with the AT LARA IOL or the AT LARA and AT LISA tri IOLs or their toric versions
- Age 18 and older
- Uncomplicated implantation of study IOLs
- No visual acuity limiting pathologies
- Clear intraocular media
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Written informed consent for participation in the study and data protection
Who cannot join
- Visual potential of less than 0.63 (decimal) in each eye due to ocular pathologies, e.g. retinal disorders
- Postoperative CDVA >0.2 log MAR
- Visual field loss which has impact on visual acuity
- Use of systemic or ocular medication that might affect vision
- Acute or chronic disease, illness, ocular trauma or surgery that would confound results (e.g. macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
- Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus
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- Capsular or zonular abnormalities that have affected postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
- Patient participates in other clinical trial (former participation is no exclusion criterion)
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Goethe University
Frankfurt
Augentagesklinik Rheine
Rheine, 48429
About this study
Official title: Visual Performance of Patients With Either Bilateral Implantation of the ZEISS AT LARA or the ZEISS AT LARA in One Eye and ZEISS AT LISA Tri in the Other (Presbyopia IOL Concept Evaluation).
The purpose of this study is to obtain postoperative visual performance data of patients with bilateral implantation of the AT LARA IOL or the AT LARA implanted in the dominant eye and AT LISA tri implanted in the other eye. Dependence on spectacles, the occurrence of photic phenomena and patient and surgeon satisfaction with the patient's visual performance will be documented. Furthermore, the refraction data will be used to optimize the IOL constants for IOL power calculations.
Read the detailed description
An extended depth of field can enable patients to do most everyday tasks without glasses. Compared to MIOLs, side effects such as glare and halo perception are expected to be less frequent and with lower intensity. This study is designed to assess visual performance and satisfaction in patients who underwent bilateral AT LARA IOL implantation or a mixed implantation of AT LARA in the dominant eye and AT LISA tri in the non-dominant eye. All patients will be offered enrolment after successful implantation in both eyes. Therefore, the preoperative and surgical data are recorded retrospectively, the follow-up examinations will be documented prospectively. This approach is justified and does not cause bias, as the purpose of this study is to investigate the performance of the IOL after successful implantation and uncomplicated surgery.
In this retrospective/prospective, non-randomized study, subjects will receive either binocular implantation of AT LARA/AT LARA toric or AT LARA/AT LARA toric in the distance dominant eye and AT LISA tri/AT LISA tri toric in the non-dominant eye. The main outcome parameter is best corrected visual acuity (CDVA). Secondary outcome parameters are: preferred near and intermediate distance, UDVA, DCIVA (Salzburg Reading desk in preferred distance), DCNVA (Salzburg Reading Desk in preferred near distance), distance corrected intermediate and near visual acuity with different contrast settings (Salzburg Reading Desk), manifest refraction, monocular and binocular defocus curve analysis, dysphotopsia simulation (Halo \& Glare Simulator), subjective patient satisfaction (MacAlinden) questionnaire.
Patients have different demands for intermediate and near vision as well as distances needed for daily routine. Comparing both groups indicates there is individual lens fitting for patients depending on their own needs. Subjects are to be evaluated 2-4 months and 5-8 months after implantation of either configuration.
- Conditions
- Cataract
- Being tested
- AT LARA IOL, AT LISA Tri IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT LARA IOLDevice
EDOF IOL for treatment of cataract
AT LISA Tri IOLDevice
Trifocal IOL for treatment of cataract
| Study group | Role | What they receive |
|---|---|---|
| Binocular EDOF IOL | Active comparator | Binocular EDOF IOL for treatment of cataract Receives: Device: AT LARA IOL |
| Combined Edof and Trifocal IOL | Experimental | Combined EDOF and Trifocal IOL - EDOF in the distance dominant eye / Trifocal in the non-dominant eye Receives: Device: AT LARA IOL; Device: AT LISA Tri IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in preoperative and postoperative binocular Corrected Distance Visual Acuity (CDVA)
The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded.
Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded.
Uncorrected visual acuity will be scored for distance, intermediate and near vision:
- logMAR 0.0 or better = 5
- logMar 0.1 = 4
- logMar 0.2 = 3
- logMar 0.3 = 2
- logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.
Measured: Pre-op, 2-4 Months, & 5-8 Months
Secondary outcomes (10)
Postoperative uncorrected monocular and binocular distance visual acuity
The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded.
Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded.
Uncorrected visual acuity will be scored for distance, intermediate and near vision:
- logMAR 0.0 or better = 5
- logMar 0.1 = 4
- logMar 0.2 = 3
- logMar 0.3 = 2
- logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.
Measured: 2-4 Months, & 5-8 Months
Postoperative uncorrected and distance-corrected binocular near visual acuity
The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded.
Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded.
Uncorrected visual acuity will be scored for distance, intermediate and near vision:
- logMAR 0.0 or better = 5
- logMar 0.1 = 4
- logMar 0.2 = 3
- logMar 0.3 = 2
- logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.
Measured: 2-4 Months, & 5-8 Months
Postoperative uncorrected and distance-corrected binocular intermediate visual acuity
The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded.
Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded.
Uncorrected visual acuity will be scored for distance, intermediate and near vision:
- logMAR 0.0 or better = 5
- logMar 0.1 = 4
- logMar 0.2 = 3
- logMar 0.3 = 2
- logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.
Measured: 2-4 Months, & 5-8 Months
Reading speed and acuity, and preferred reading distance (Salzburg reading desk)
Sites at which the Salzburg Reading Desk is available will examine reading speed and acuity at 40 cm and 66 cm at the two postoperative visits. The following parameters will be documented: words per minute (WPM), characters per minute (CPM), words missed (reading speed recalculated when missed words are selected), LogMAR reading acuity, average reading distance, average reading time.
Measured: 2-4 Months, & 5-8 Months
Postoperative use of spectacles (near, intermediate, distance)
The surgeon asks: "How often do you need glasses for near/intermediate/distance vision?". The answers are classified into 0%, 25%, 50%, 75% and 100% of the total time.
Measured: 2-4 Months, & 5-8 Months
Photic phenomena
The McAlinden Quality of Vision (QoV) questionnaire will be used to assess the size and intensity of halo and glare
Measured: 2-4 Months, & 5-8 Months
Defocus curve
Best-corrected distance defocus curve testing from +1.0 D to -4.0 D shall be performed. The image shall be defocused in -0.5 D increments with spherical minus lenses and a visual acuity measurement is obtained at each defocus increment.
Measured: 2-4 Months, & 5-8 Months
Patient satisfaction
The McAlinden Quality of Vision (QoV) questionnaire will be used to assess patient satisfaction. Patients are asked two closed answered questions, with Yes or No being the answer. 'Would you decide to have multifocal IOLs again?' and ' Would you recommend the same lens to your relatives and friends?'
Measured: 2-4 Months, & 5-8 Months
Surgeon's assessment
The surgeon completes a short questionnaire on the handling and performance of the lens. The ease of implantation, achievement of the target refraction, satisfaction with the patient's vision and general satisfaction are recorded.
Measured: 2-4 Months, & 5-8 Months
Optimization of IOL-constants
For this purpose, the corneal radii, the axial length, the measured anterior chamber depth and the implanted IOL power are recorded during biometry to determine the correct IOL power. Postoperatively, the subjective refraction achieved is documented as spherical equivalent and forwarded to Prof. Dr. Achim Langenbucher, Medical Faculty of Saarland University, Experimental Ophthalmology, for evaluation with the IOL-Con software
Measured: 2-4 Months, & 5-8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start14 Mar 2019
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florian Kretz, Principal investigator, Augentagesklinik Rheine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462067
- Sponsor's protocol ID
- GPAS-LARALISA-2018-01
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moore J, Ostergaard J, Kretz F. Visual performance and patient preference with bilateral implantation of an extended depth of focus or combined implantation of an extended depth of focus/trifocal intraocular lens. Int Ophthalmol. 2024 Feb 14;44(1):80. doi: 10.1007/s10792-024-03030-y.
PubMed 38356027
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance of Patients With Either Bilateral Implantation of the ZEISS AT LARA or the ZEISS AT LARA in One Eye and ZEISS AT LISA Tri in the Other (Presbyopia IOL Concept Evaluation).
- ClinicalTrials.gov ID
- NCT05462067
- Acronym / sponsor ID
- GPAS-LARALISA-2018-01
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 18 Jul 2022 (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.
The purpose of this study is to obtain postoperative visual performance data of patients with bilateral implantation of the AT LARA IOL or the AT LARA implanted in the dominant eye and AT LISA tri implanted in the other eye. Dependence on spectacles, the occurrence of photic phenomena and patient and surgeon satisfaction with the patient's visual performance will be documented. Furthermore, the refraction data will be used to optimize the IOL constants for IOL power calculations.
Detailed description
An extended depth of field can enable patients to do most everyday tasks without glasses. Compared to MIOLs, side effects such as glare and halo perception are expected to be less frequent and with lower intensity. This study is designed to assess visual performance and satisfaction in patients who underwent bilateral AT LARA IOL implantation or a mixed implantation of AT LARA in the dominant eye and AT LISA tri in the non-dominant eye. All patients will be offered enrolment after successful implantation in both eyes. Therefore, the preoperative and surgical data are recorded retrospectively, the follow-up examinations will be documented prospectively. This approach is justified and does not cause bias, as the purpose of this study is to investigate the performance of the IOL after successful implantation and uncomplicated surgery.
In this retrospective/prospective, non-randomized study, subjects will receive either binocular implantation of AT LARA/AT LARA toric or AT LARA/AT LARA toric in the distance dominant eye and AT LISA tri/AT LISA tri toric in the non-dominant eye. The main outcome parameter is best corrected visual acuity (CDVA). Secondary outcome parameters are: preferred near and intermediate distance, UDVA, DCIVA (Salzburg Reading desk in preferred distance), DCNVA (Salzburg Reading Desk in preferred near distance), distance corrected intermediate and near visual acuity with different contrast settings (Salzburg Reading Desk), manifest refraction, monocular and binocular defocus curve analysis, dysphotopsia simulation (Halo \& Glare Simulator), subjective patient satisfaction (MacAlinden) questionnaire.
Patients have different demands for intermediate and near vision as well as distances needed for daily routine. Comparing both groups indicates there is individual lens fitting for patients depending on their own needs. Subjects are to be evaluated 2-4 months and 5-8 months after implantation of either configuration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binocular EDOF IOL | Active comparator | Device: AT LARA IOLBinocular EDOF IOL for treatment of cataract |
| Combined Edof and Trifocal IOL | Experimental | Device: AT LARA IOL, Device: AT LISA Tri IOLCombined EDOF and Trifocal IOL - EDOF in the distance dominant eye / Trifocal in the non-dominant eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients bilaterally implanted with the AT LARA IOL or the AT LARA and AT LISA tri IOLs or their toric versions
- Age 18 and older
- Uncomplicated implantation of study IOLs
- No visual acuity limiting pathologies
- Clear intraocular media
Key exclusion criteria (9 listed)
- Visual potential of less than 0.63 (decimal) in each eye due to ocular pathologies, e.g. retinal disorders
- Postoperative CDVA >0.2 log MAR
- Visual field loss which has impact on visual acuity
- Use of systemic or ocular medication that might affect vision
- Acute or chronic disease, illness, ocular trauma or surgery that would confound results (e.g. macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
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 |
|---|---|---|
| AT LARA IOLEDOF IOL for treatment of cataract | Device | Binocular EDOF IOL, Combined Edof and Trifocal IOL |
| AT LISA Tri IOLTrifocal IOL for treatment of cataract | Device | Combined Edof and Trifocal IOL |
Primary outcome
Change in preoperative and postoperative binocular Corrected Distance Visual Acuity (CDVA)
Time frame: Pre-op, 2-4 Months, & 5-8 Months
The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded. Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded. Uncorrected visual acuity will be scored for distance, intermediate and near vision: * logMAR 0.0 or better = 5 * logMar 0.1 = 4 * logMar 0.2 = 3 * logMar 0.3 = 2 * logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.
10 secondary outcomes
Postoperative uncorrected monocular and binocular distance visual acuity
Time frame: 2-4 Months, & 5-8 Months
Postoperative uncorrected and distance-corrected binocular near visual acuity
Time frame: 2-4 Months, & 5-8 Months
Postoperative uncorrected and distance-corrected binocular intermediate visual acuity
Time frame: 2-4 Months, & 5-8 Months
Reading speed and acuity, and preferred reading distance (Salzburg reading desk)
Time frame: 2-4 Months, & 5-8 Months
Postoperative use of spectacles (near, intermediate, distance)
Time frame: 2-4 Months, & 5-8 Months
Photic phenomena
Time frame: 2-4 Months, & 5-8 Months
Defocus curve
Time frame: 2-4 Months, & 5-8 Months
Patient satisfaction
Time frame: 2-4 Months, & 5-8 Months
Surgeon's assessment
Time frame: 2-4 Months, & 5-8 Months
Optimization of IOL-constants
Time frame: 2-4 Months, & 5-8 Months
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 18 Jul 2022.
- Derived from this study: PubMed 38356027Moore J, Ostergaard J, Kretz F. Visual performance and patient preference with bilateral implantation of an extended depth of focus or combined implantation of an extended depth of focus/trifocal intraocular lens. Int Ophthalmol. 2024 Feb 14;44(1):80. doi: 10.1007/s10792-024-03030-y.
- Individual participant dataSharing planned: No
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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.
Florian Kretz principal investigator
Augentagesklinik Rheine
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AT LARA IOL and AT LISA Tri IOL in people with Cataract, run by Carl Zeiss Meditec AG at 4 sites in 3 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 7 inclusion and 9 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 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Denmark, Ireland. 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?
Change in preoperative and postoperative binocular Corrected Distance Visual Acuity (CDVA) (time frame: Pre-op, 2-4 Months, & 5-8 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 NCT05462067, which also lists 1 linked publication.
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 18 Jul 2022.