Clinical Trials in Spain / NCT06105190
Active, not recruiting
Not applicable
Clinical Study to Evaluate Clinical Outcomes of LuxSmart IOL as Compared With LuxGood IOL
NCT06105190 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
CataractLens Opacities
Investigational drug(s) / intervention(s)
Implantation of premium monofocal IOL, LuxSmart (device under investigation)Implantation of monofocal IOL, LuxGood (control device)
Implantation of premium monofocal IOL, LuxSmart (device under investigation): Patients will be implanted with study IOL in both eyes
Implantation of monofocal IOL, LuxGood (control device): Patients will be implanted with Control IOL in both eyes
Study 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).
Eligibility
Inclusion Criteria:
1. Clinically documented age-related cataracts in both eyes;
2. Calculated IOL power performed using an optical biometer is within the range of the study and control IOLs (15D to 28D);
3. Male or female adults aged 22 years or older on the day of first-eye surgery;
4. Regular corneal astigmatism ≤ 1.0 D (measured by IOL Master) in both eyes;
5. Clear intraocular media other than cataract in both eyes;
6. Willing and able to comply to the study requirements;
7. Capability to understand and sign an IRB approved informed consent form and privacy authorization;
8. Monocular best corrected visual acuity projected to be ≤ 0.18 logMAR (≥ 20/30 in Snellen) after IOL implantation in both eyes;
9. 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;
10. 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;
Exclusion Criteria:
1. Regular corneal astigmatism \>1.0 D (measured by IOL Master) in one or both eyes;
2. Irregular astigmatism (measured by a topographer) in both eyes;
3. Difficulties for cooperation;
4. 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;
5. Subjects with AMD suspicious eyes as determined by OCT examination;
6. Previous intraocular or corneal surgery in one or both eyes;
7. Traumatic cataract in one or both eyes as judged by investigator;
8. History or presence of macular edema in one or both eyes;
9. Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D in both eyes;
10. Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and / or visual acuity outcomes in one or both eyes;
11. Pupil abnormalities (non-reactive, tonic, abnormally shaped) in one or both eyes;
12. Subjects that cannot achieve a minimum pharmacologic pupilar dilatation of 5 mm in one or both eyes;
13. Complicated surgery expected;
14. Ocular surface disease (clinical symptoms) in one or both eyes;
15. Clinically significant dry eye as determined by the investigator's judgement in one or both eyes;
16. Anterior segment pathology that might increase intraoperative risk or compromise IOL stability;
17. Diabetic retinopathy;
18. Congenital ocular anomalies;
19. Chronic or recurrent inflammatory eye diseases;
20. Active infectious conjunctivitis, keratitis or uveitis in either eye within 30 days prior to surgery;
21. Subjects who may be expected to require a combined or other surgical procedure in either eye;
22. Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
23. Concurrent or previous (within 30 days) participation in another drug or device investigation;
24. 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);
25. 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;
26. Subjects who are expected to require retinal laser treatment;
27. Patients showing contraindications as listed in the current Instructions for use (IFU);
28. 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.
Primary outcome measure(s)
- Primary Safety Endpoint: Mean Corrected Distance Visual Acuity — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Univ.-Klinik fuer Augenheilkunde und Optometrie | Vienna | Austria | |
| Gemini Eye Clinic Vyškov | Vyškov | Czechia | |
| Gemini Eye Clinic Zlín | Zlín | Czechia | |
| Augenklinik Ahaus | Ahaus | Germany | |
| Univ.-Klinikum Knappschaftskrankenhaus Bochum | Bochum | Germany | |
| Asian Eye Institute | Makati City | Manila | |
| Tan Tock Seng Hospital | Singapore | Singapore | |
| Hospital Miguel Servet | Zaragoza | Spain |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06105190 on ClinicalTrials.gov ↗ ← All trials in Spain