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

NCT06105190 | Active Not Recruiting

• 1 other identifier: CE2201
• Study Type: interventional
• Target: 251
• Locations: 6 countries
• Sites: 8

Brief 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).

Conditions

Cataract; Lens Opacities

Keywords

Intraocular Lens; IOL; hydrophobic; EDOF

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (3)

• Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data

  120-180 days postoperative

• Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)

  120-180 days postoperative

• Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)

  120-180 days postoperative

Other Outcomes (41)

• Binocular best-corrected distance defocus

  120-180 days postoperative

• Manifest refraction

  Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative

• Adjusted Mean Refractive Spherical Equivalent (MRSE)

  7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative

Study Arms (2)

IOL implantation experimental

EXPERIMENTAL

Experimental arm: Premium monofocal intraocular lens LuxSmart

Device: Implantation of premium monofocal IOL, LuxSmart (device under investigation)

IOL implantation active comparator

ACTIVE COMPARATOR

Comparator arm: Monofocal intraocular lens LuxGood

Device: Implantation of monofocal IOL, LuxGood (control device)

Interventions

Implantation of premium monofocal IOL, LuxSmart (device under investigation) DEVICE

Patients will be implanted with study IOL in both eyes

IOL implantation experimental

Implantation of monofocal IOL, LuxGood (control device) DEVICE

Patients will be implanted with Control IOL in both eyes

IOL implantation active comparator

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cutting Edge SAS: lead
• targomedGmbH: collaborator

Study Sites (8)

Univ.-Klinik fuer Augenheilkunde und Optometrie

Vienna, 1090, Austria

Location

Gemini Eye Clinic Vyškov

Vyškov, 682 01, Czechia

Location

Gemini Eye Clinic Zlín

Zlín, 760 01, Czechia

Location

Augenklinik Ahaus

Ahaus, 48683, Germany

Location

Univ.-Klinikum Knappschaftskrankenhaus Bochum

Bochum, 44892, Germany

Location

Asian Eye Institute

Makati City, Manila, 1200, Philippines

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (2)

• 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.

  PMID: 20505205 BACKGROUND

• Lundstrom 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.

  PMID: 19251145 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Burkhard Dick, Prof.

  Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study is planned as a double-masked study. The subjects will not be informed about the implanted lens before exiting the study. Only the investigator implanting the lens as well as one administrative person will know about the arm, the subject is assigned to. Outcome assessors will not be able to receive information about the implanted lens. Data analyst will get to know about the patient assignment after data evaluation only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 27, 2023
• Study Start: June 21, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); CZ (2); AU (1); PH (1); DE (2); SG (1)