Clinical Study to Evaluate Clinical Outcomes of LuxSmart IOL as Compared With LuxGood IOL

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cataract, Lens Opacities

Intervention / Treatment
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* Device: Implantation of premium monofocal IOL, LuxSmart (device under investigation)
* Device: Implantation of monofocal IOL, LuxGood (control device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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; Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IOL implantation experimental<br>Experimental arm: Premium monofocal intraocular lens LuxSmart | Device: Implantation of premium monofocal IOL, LuxSmart (device under investigation)<br>* Patients will be implanted with study IOL in both eyes<br>|
| Active Comparator: IOL implantation active comparator<br>Comparator arm: Monofocal intraocular lens LuxGood | Device: Implantation of monofocal IOL, LuxGood (control device)<br>* Patients will be implanted with Control IOL in both eyes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 120-180 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 120-180 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Lens, IOL, hydrophobic, EDOF