CataractNCT06105190
Clinical Study to Evaluate Clinical Outcomes of LuxSmart IOL as Compared With LuxGood IOL
A study testing Implantation of premium monofocal IOL, LuxSmart (device under investigation) in people with Cataract and Lens Opacities, run by Cutting Edge SAS at 8 sites in 6 countries.
Trial summary
This study is a multicentric, prospective, randomised, controlled, post-market clinical follow up (PMCF) study to investigate safety, visual outcomes and contrast sensitivity after bilateral implantation of either LuxSmart IOLs (study group) or LuxGood IOLs (control group). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Lens Opacities
- What is being tested?
- Implantation of premium monofocal IOL, LuxSmart (device under investigation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 21 Jun 2023to Apr 2025
- Phase
- Interventional
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically documented age-related cataracts in both eyes;
- Calculated IOL power performed using an optical biometer is within the range of the study and control IOLs (15D to 28D);
- Male or female adults aged 22 years or older on the day of first-eye surgery;
- Regular corneal astigmatism ≤ 1.0 D (measured by IOL Master) in both eyes;
- Clear intraocular media other than cataract in both eyes;
- Willing and able to comply to the study requirements;
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- Capability to understand and sign an IRB approved informed consent form and privacy authorization;
- Monocular best corrected visual acuity projected to be ≤ 0.18 logMAR (≥ 20/30 in Snellen) after IOL implantation in both eyes;
- Subjects must have discontinued use of contact lenses for at least two weeks (for hard or toric lenses) or 3 days (for soft non-toric contact lenses) prior to the pre-operative examination, and throughout the clinical study;
- Current contact lens wearers must demonstrate a stable refraction (within ±0.5 D for both sphere and cylinder) in each eye, as determined by distance manifest refraction on two consecutive examination dates after discontinuation of contact lens wear;
Who cannot join
- Regular corneal astigmatism >1.0 D (measured by IOL Master) in one or both eyes;
- Irregular astigmatism (measured by a topographer) in both eyes;
- Difficulties for cooperation;
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity loss to 20/30 or worse in one or both eyes;
- Subjects with AMD suspicious eyes as determined by OCT examination;
- Previous intraocular or corneal surgery in one or both eyes;
Show all 33Show fewer
- Traumatic cataract in one or both eyes as judged by investigator;
- History or presence of macular edema in one or both eyes;
- Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D in both eyes;
- Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and / or visual acuity outcomes in one or both eyes;
- Pupil abnormalities (non-reactive, tonic, abnormally shaped) in one or both eyes;
- Subjects that cannot achieve a minimum pharmacologic pupilar dilatation of 5 mm in one or both eyes;
- Complicated surgery expected;
- Ocular surface disease (clinical symptoms) in one or both eyes;
- Clinically significant dry eye as determined by the investigator's judgement in one or both eyes;
- Anterior segment pathology that might increase intraoperative risk or compromise IOL stability;
- Diabetic retinopathy;
- Congenital ocular anomalies;
- Chronic or recurrent inflammatory eye diseases;
- Active infectious conjunctivitis, keratitis or uveitis in either eye within 30 days prior to surgery;
- Subjects who may be expected to require a combined or other surgical procedure in either eye;
- Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
- Concurrent or previous (within 30 days) participation in another drug or device investigation;
- Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator (tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome);
- Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens;
- Subjects who are expected to require retinal laser treatment;
- Patients showing contraindications as listed in the current Instructions for use (IFU);
- Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).
- In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:
- zonular instability;
- need for iris manipulation;
- capsular fibrosis or other opacity; and
- inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Czechia2 sites
Gemini Eye Clinic Vyškov
Vyškov, 682 01
Gemini Eye Clinic Zlín
Zlín, 760 01
Germany2 sites
Augenklinik Ahaus
Ahaus, 48683
Univ.-Klinikum Knappschaftskrankenhaus Bochum
Bochum, 44892
About this study
Official title: Prospective, Multicenter, Controlled, Randomized, Masked Study to Evaluate the Safety and Performance of LuxSmart IOL as Compared With LuxGood IOL In Subjects Undergoing Cataract Extraction
This study is a multicentric, prospective, randomised, controlled, post-market clinical follow up (PMCF) study to investigate safety, visual outcomes and contrast sensitivity after bilateral implantation of either LuxSmart IOLs (study group) or LuxGood IOLs (control group).
Read the detailed description
This study is a multicentric, prospective, randomised, controlled, post-market clinical follow up (PMCF) study whereby subjects undergoing routine cataract surgery will have bilateral implantation of either LuxSmart IOLs (study group) or LuxGood IOLs (control group).
The subjects will be randomized in a 1:1 ratio to receive the study or control lenses.
Both study and control IOLs, are CE approved The study and control IOLs, and all devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the subject.
The study device (LuxSmart) is a hydrophobic, premium monofocal intraocular lens (IOL) manufactured by the sponsor of this study. The control lens (LuxGood) is the monofocal parent lens sharing the same material and optic design but with slight differences in the optic design. The IOLs will be implanted as part of the routine cataract surgery on subjects suffering from cataract. The targeted study cohort represents the standard subject cohort for cataract surgery.
In total 238 subjects will be enrolled for this clinical study and receive bilateral implantation of the study or control lens based on a 1:1 randomization given by the EDC.
Subjects participating in the trial will attend a total of 6 to 10 study visits (1 preoperative, 1 or 2 operative and 4 - 7 postoperative visits that may be carried out at the same day if requirements allow) over a period of 6 months.
Data analyses will be performed after the last patient finished the 120-180 days postoperative examination.
- Conditions
- Cataract, Lens Opacities
- Being tested
- Implantation of premium monofocal IOL, LuxSmart (device under investigation), Implantation of monofocal IOL, LuxGood (control device)
- Keywords
- Intraocular Lens, IOL, hydrophobic, EDOF
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of premium monofocal IOL, LuxSmart (device under investigation)Device
Patients will be implanted with study IOL in both eyes
Implantation of monofocal IOL, LuxGood (control device)Device
Patients will be implanted with Control IOL in both eyes
| Study group | Role | What they receive |
|---|---|---|
| IOL implantation experimental | Experimental | Experimental arm: Premium monofocal intraocular lens LuxSmart Receives: Device: Implantation of premium monofocal IOL, LuxSmart (device under investigation) |
| IOL implantation active comparator | Active comparator | Comparator arm: Monofocal intraocular lens LuxGood Receives: Device: Implantation of monofocal IOL, LuxGood (control device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Mean Corrected Distance Visual Acuity
The primary safety endpoint is to show that the mean monocular Corrected Distance Visual Acuity (CDVA) at at 120-180 days postoperative is statistically non-inferior to outcomes obtained in the control group using a non-inferiority margin of 0.1 logMAR, a 1-sided test and a significance level of 0.05. This analysis will be done for first implanted eyes as well as all implanted eyes per subject.
Measured: 120-180 days postoperative
Co-Primary Safety Endpoint: Monocular Contrast Sensitivity - Between-group mean difference
The co-primary safety endpoint is to compare the outcomes on monocular contrast sensitivity under mesopic light conditions (with and without glare) between the study and the control group at 120-180 days postoperative. This analysis will be done for first implanted eyes per subject.
The following Log Contrast Sensitivity Analysis will be performed:
- Between-group mean difference in log contrast sensitivity with 90% non-parametric confidence interval for each spatial frequency.
Measured: 120-180 days postoperative
Co-Primary Safety Endpoint: Monocular Contrast Sensitivity - descriptive statistics
The co-primary safety endpoint is to compare the outcomes on monocular contrast sensitivity under mesopic light conditions (with and without glare) between the study and the control group at 120-180 days postoperative. This analysis will be done for first implanted eyes per subject.
The following Log Contrast Sensitivity Analysis will be performed:
- Provide descriptive statistics for the log contrast sensitivity for each group (mean, SD, median, 0th, 25th, 50th 75th, and 100th percentiles) and for each spatial frequency.
Measured: 120-180 days postoperative
Co-Primary Safety Endpoint: Monocular Contrast Sensitivity - frequency with glare
The co-primary safety endpoint is to compare the outcomes on monocular contrast sensitivity under mesopic light conditions with glare between the study and the control group at 120-180 days postoperative. This analysis will be done for first implanted eyes per subject.
The following Log Contrast Sensitivity Analysis will be performed:
- The percentage of eyes that can and cannot see the reference pattern for each spatial frequency.
Measured: 120-180 days postoperative
Co-Primary Safety Endpoint: Monocular Contrast Sensitivity - frequency without glare
The co-primary safety endpoint is to compare the outcomes on monocular contrast sensitivity under mesopic light conditions without glare between the study and the control group at 120-180 days postoperative. This analysis will be done for first implanted eyes per subject.
The following Log Contrast Sensitivity Analysis will be performed:
- The percentage of eyes that can and cannot see the reference pattern for each spatial frequency.
Measured: 120-180 days postoperative
Co-Primary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data
The objective is to compare best corrected distance visual acuities (CDVA) above defined thresholds of the investigational product to the normative data stated in the according ISO norm (EN ISO 11979-7:2018) for posterior chamber intraocular lenses.
Measured: 120-180 days postoperative
Co-Primary Safety Endpoint: Rates of Adverse Events
The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to reference data stated in the according ISO standard for posterior intraocular lenses (EN ISO 11979-7:2018) based on minimum 100 subjects.
Measured: 120-180 days postoperative
Co-Primary Safety Endpoint: Incidence of all SAE
The incidence of all Serious Adverse Events, including Secondary Surgical Interventions (SSIs) related to the optical properties of the IOL, in first-implanted eyes as well as all implanted eyes will be collected through Post-Operative Visit 4 (120 to 180 days after first and second eye implantation).
The proportion of first implanted eyes and all implanted eyes with at least one serious adverse event will be summarized using categorical summary statistics by treatment received. Each eye will be counted only once in the calculation of the rate.
There is no statistical hypothesis associated with the proportion of first implanted eyes with at least one serious adverse event.
Measured: 120-180 days postoperative
Co-Primary Safety Endpoint: Rate of SSI Related to Optical Properties of the IOL
The rate of SSIs related to the optical properties of the IOL for first-implanted eyes as well as all implanted eyes will be reported through 120 to 180 days after first and second eye implantation.
Secondary surgical interventions related to the optical properties of the IOL will be defined as IOL explantation, replacement, or repositioning due to subject intolerance of visual symptoms not adequately improved by spectacle correction. Each eye will be classified as either having undergone a secondary surgical intervention related to the optical properties of the IOL or not having undergone such an intervention. Secondary surgical interventions related to the optical properties of the IOL will be summarized categorically (Yes, No) by actual treatment received in a table.
Measured: 120-180 days postoperative
Primary Performance Endpoint: Mean Distance Corrected Intermediate Visual Acuity
The primary efficacy endpoint is to show that the monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 120-180 days postoperative is statistically superior to outcomes obtained in the control group (1 sided test using significance of 0.025). To avoid bias, only the first implanted eye per subject will be considered for this calculation.
Measured: 120-180 days postoperative
Co-Primary Performance Endpoint: Cumulative Distance Corrected Intermediate Visual Acuity
One co-primary efficacy endpoint is to show that the outcomes of the study device on monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm at 120-180 days postoperative needs to have at least 50% of eyes achieving 0.2 logMAR or better. To avoid bias, only the first implanted eye per subject will be considered for this calculation.
Measured: 120-180 days postoperative
Co-Primary Performance Endpoint: Monocular best-corrected distance defocus
Monocular best-corrected distance defocus testing will be performed. The defocus range where the mean visual acuity of 0.2 logMAR or better is achieved will be derived by visual inspection of the mean defocus curve. The monocular depth of focus is defined as the defocus range from zero to the first negative vergence level, where the visual acuity is 0.2 logMAR or less.
One co-primary efficacy endpoint is to show that the monocular depth of focus for the eyes implanted with the study device is at least 0.5 D greater than the depth of focus for the eyes implanted with the control device at 0.2 logMAR.
Measured: 120-180 days postoperative
Secondary outcomes (3)
Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data
The objective is to compare best corrected distance visual acuities (CDVA) above defined thresholds of the investigational product to the normative data stated in the according ISO norm (EN ISO 11979-7:2018) for posterior chamber intraocular lenses.
Measured: 120-180 days postoperative
Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)
Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions on the first implanted eye.
Measured: 120-180 days postoperative
Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)
Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions on the first implanted eye.
Measured: 120-180 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start21 Jun 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutting Edge SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- targomedGmbH
- Responsible party
- Sponsor
- Investigators
- Burkhard Dick, Prof., Principal investigator, Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105190
- Sponsor's protocol ID
- CE2201
- Status last verified
- Feb 2025
- First submitted
- 18 Oct 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
PubMed 20505205Lundstrom M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038.
PubMed 19251145
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Controlled, Randomized, Masked Study to Evaluate the Safety and Performance of LuxSmart IOL as Compared With LuxGood IOL In Subjects Undergoing Cataract Extraction
- ClinicalTrials.gov ID
- NCT06105190
- Acronym / sponsor ID
- CE2201
- Conditions
- Cataract, Lens Opacities
- Keywords
- Intraocular Lens, IOL, hydrophobic, EDOF
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Cutting Edge SASIndustry (pharma, biotech, devices)
- Collaborators
- targomedGmbH
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 27 Oct 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 a multicentric, prospective, randomised, controlled, post-market clinical follow up (PMCF) study to investigate safety, visual outcomes and contrast sensitivity after bilateral implantation of either LuxSmart IOLs (study group) or LuxGood IOLs (control group).
Detailed description
This study is a multicentric, prospective, randomised, controlled, post-market clinical follow up (PMCF) study whereby subjects undergoing routine cataract surgery will have bilateral implantation of either LuxSmart IOLs (study group) or LuxGood IOLs (control group).
The subjects will be randomized in a 1:1 ratio to receive the study or control lenses.
Both study and control IOLs, are CE approved The study and control IOLs, and all devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the subject.
The study device (LuxSmart) is a hydrophobic, premium monofocal intraocular lens (IOL) manufactured by the sponsor of this study. The control lens (LuxGood) is the monofocal parent lens sharing the same material and optic design but with slight differences in the optic design. The IOLs will be implanted as part of the routine cataract surgery on subjects suffering from cataract. The targeted study cohort represents the standard subject cohort for cataract surgery.
In total 238 subjects will be enrolled for this clinical study and receive bilateral implantation of the study or control lens based on a 1:1 randomization given by the EDC.
Subjects participating in the trial will attend a total of 6 to 10 study visits (1 preoperative, 1 or 2 operative and 4 - 7 postoperative visits that may be carried out at the same day if requirements allow) over a period of 6 months.
Data analyses will be performed after the last patient finished the 120-180 days postoperative examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOL implantation experimental | Experimental | Device: Implantation of premium monofocal IOL, LuxSmart (device under investigation)Experimental arm: Premium monofocal intraocular lens LuxSmart |
| IOL implantation active comparator | Active comparator | Device: Implantation of monofocal IOL, LuxGood (control device)Comparator arm: Monofocal intraocular lens LuxGood |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinically documented age-related cataracts in both eyes;
- Calculated IOL power performed using an optical biometer is within the range of the study and control IOLs (15D to 28D);
- Male or female adults aged 22 years or older on the day of first-eye surgery;
- Regular corneal astigmatism ≤ 1.0 D (measured by IOL Master) in both eyes;
- Clear intraocular media other than cataract in both eyes;
Key exclusion criteria (33 listed)
- Regular corneal astigmatism >1.0 D (measured by IOL Master) in one or both eyes;
- Irregular astigmatism (measured by a topographer) in both eyes;
- Difficulties for cooperation;
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity loss to 20/30 or worse in one or both eyes;
- Subjects with AMD suspicious eyes as determined by OCT examination;
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 |
|---|---|---|
| Implantation of premium monofocal IOL, LuxSmart (device under investigation)Patients will be implanted with study IOL in both eyes | Device | IOL implantation experimental |
| Implantation of monofocal IOL, LuxGood (control device)Patients will be implanted with Control IOL in both eyes | Device | IOL implantation active comparator |
Primary outcome
Primary Safety Endpoint: Mean Corrected Distance Visual Acuity
Time frame: 120-180 days postoperative
The primary safety endpoint is to show that the mean monocular Corrected Distance Visual Acuity (CDVA) at at 120-180 days postoperative is statistically non-inferior to outcomes obtained in the control group using a non-inferiority margin of 0.1 logMAR, a 1-sided test and a significance level of 0.05. This analysis will be done for first implanted eyes as well as all implanted eyes per subject.
Co-Primary Safety Endpoint: Monocular Contrast Sensitivity - Between-group mean difference
Time frame: 120-180 days postoperative
The co-primary safety endpoint is to compare the outcomes on monocular contrast sensitivity under mesopic light conditions (with and without glare) between the study and the control group at 120-180 days postoperative. This analysis will be done for first implanted eyes per subject. The following Log Contrast Sensitivity Analysis will be performed: - Between-group mean difference in log contrast sensitivity with 90% non-parametric confidence interval for each spatial frequency.
Co-Primary Safety Endpoint: Monocular Contrast Sensitivity - descriptive statistics
Time frame: 120-180 days postoperative
The co-primary safety endpoint is to compare the outcomes on monocular contrast sensitivity under mesopic light conditions (with and without glare) between the study and the control group at 120-180 days postoperative. This analysis will be done for first implanted eyes per subject. The following Log Contrast Sensitivity Analysis will be performed: - Provide descriptive statistics for the log contrast sensitivity for each group (mean, SD, median, 0th, 25th, 50th 75th, and 100th percentiles) and for each spatial frequency.
Co-Primary Safety Endpoint: Monocular Contrast Sensitivity - frequency with glare
Time frame: 120-180 days postoperative
The co-primary safety endpoint is to compare the outcomes on monocular contrast sensitivity under mesopic light conditions with glare between the study and the control group at 120-180 days postoperative. This analysis will be done for first implanted eyes per subject. The following Log Contrast Sensitivity Analysis will be performed: - The percentage of eyes that can and cannot see the reference pattern for each spatial frequency.
Co-Primary Safety Endpoint: Monocular Contrast Sensitivity - frequency without glare
Time frame: 120-180 days postoperative
The co-primary safety endpoint is to compare the outcomes on monocular contrast sensitivity under mesopic light conditions without glare between the study and the control group at 120-180 days postoperative. This analysis will be done for first implanted eyes per subject. The following Log Contrast Sensitivity Analysis will be performed: - The percentage of eyes that can and cannot see the reference pattern for each spatial frequency.
Co-Primary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data
Time frame: 120-180 days postoperative
The objective is to compare best corrected distance visual acuities (CDVA) above defined thresholds of the investigational product to the normative data stated in the according ISO norm (EN ISO 11979-7:2018) for posterior chamber intraocular lenses.
Co-Primary Safety Endpoint: Rates of Adverse Events
Time frame: 120-180 days postoperative
The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to reference data stated in the according ISO standard for posterior intraocular lenses (EN ISO 11979-7:2018) based on minimum 100 subjects.
Co-Primary Safety Endpoint: Incidence of all SAE
Time frame: 120-180 days postoperative
The incidence of all Serious Adverse Events, including Secondary Surgical Interventions (SSIs) related to the optical properties of the IOL, in first-implanted eyes as well as all implanted eyes will be collected through Post-Operative Visit 4 (120 to 180 days after first and second eye implantation). The proportion of first implanted eyes and all implanted eyes with at least one serious adverse event will be summarized using categorical summary statistics by treatment received. Each eye will be counted only once in the calculation of the rate. There is no statistical hypothesis associated with the proportion of first implanted eyes with at least one serious adverse event.
Co-Primary Safety Endpoint: Rate of SSI Related to Optical Properties of the IOL
Time frame: 120-180 days postoperative
The rate of SSIs related to the optical properties of the IOL for first-implanted eyes as well as all implanted eyes will be reported through 120 to 180 days after first and second eye implantation. Secondary surgical interventions related to the optical properties of the IOL will be defined as IOL explantation, replacement, or repositioning due to subject intolerance of visual symptoms not adequately improved by spectacle correction. Each eye will be classified as either having undergone a secondary surgical intervention related to the optical properties of the IOL or not having undergone such an intervention. Secondary surgical interventions related to the optical properties of the IOL will be summarized categorically (Yes, No) by actual treatment received in a table.
Primary Performance Endpoint: Mean Distance Corrected Intermediate Visual Acuity
Time frame: 120-180 days postoperative
The primary efficacy endpoint is to show that the monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 120-180 days postoperative is statistically superior to outcomes obtained in the control group (1 sided test using significance of 0.025). To avoid bias, only the first implanted eye per subject will be considered for this calculation.
Co-Primary Performance Endpoint: Cumulative Distance Corrected Intermediate Visual Acuity
Time frame: 120-180 days postoperative
One co-primary efficacy endpoint is to show that the outcomes of the study device on monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm at 120-180 days postoperative needs to have at least 50% of eyes achieving 0.2 logMAR or better. To avoid bias, only the first implanted eye per subject will be considered for this calculation.
Co-Primary Performance Endpoint: Monocular best-corrected distance defocus
Time frame: 120-180 days postoperative
Monocular best-corrected distance defocus testing will be performed. The defocus range where the mean visual acuity of 0.2 logMAR or better is achieved will be derived by visual inspection of the mean defocus curve. The monocular depth of focus is defined as the defocus range from zero to the first negative vergence level, where the visual acuity is 0.2 logMAR or less. One co-primary efficacy endpoint is to show that the monocular depth of focus for the eyes implanted with the study device is at least 0.5 D greater than the depth of focus for the eyes implanted with the control device at 0.2 logMAR.
3 secondary outcomes
Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data
Time frame: 120-180 days postoperative
Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)
Time frame: 120-180 days postoperative
Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)
Time frame: 120-180 days postoperative
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 12 Feb 2025.
- Background: PubMed 20505205McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
- Background: PubMed 19251145Lundstrom M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038.
- 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.
Burkhard Dick, Prof. principal investigator
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of premium monofocal IOL, LuxSmart (device under investigation) in people with Cataract and Lens Opacities, run by Cutting Edge SAS at 8 sites in 6 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 10 inclusion and 33 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 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Czechia, Germany, Austria, Philippines, Singapore and 1 more country. 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?
Primary Safety Endpoint: Mean Corrected Distance Visual Acuity (time frame: 120-180 days postoperative). The study lists 12 primary outcomes in all. 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 NCT06105190, which also lists 2 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 12 Feb 2025.