Clinical trial NCT06105190: Clinical Study to Evaluate Clinical Outcomes of LuxSmart IOL as Compared With LuxGood IOL
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cataract
Lens Opacities
Keywords: Intraocular Lens
IOL
hydrophobic
EDOF
Lead sponsor: Cutting Edge SAS
Sponsor class: INDUSTRY
Collaborators: name: targomedGmbH
First posted: 2023-10-27
Enrollment: 251
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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 outcomes:
measure: Primary Safety Endpoint: Mean Corrected Distance Visual Acuity
timeFrame: 120-180 days postoperative
measure: Co-Primary Safety Endpoint: Monocular Contrast Sensitivity - Between-group mean difference
timeFrame: 120-180 days postoperative
measure: Co-Primary Safety Endpoint: Monocular Contrast Sensitivity - descriptive statistics
timeFrame: 120-180 days postoperative
measure: Co-Primary Safety Endpoint: Monocular Contrast Sensitivity - frequency with glare
timeFrame: 120-180 days postoperative
measure: Co-Primary Safety Endpoint: Monocular Contrast Sensitivity - frequency without glare
timeFrame: 120-180 days postoperative
measure: Co-Primary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data
timeFrame: 120-180 days postoperative
measure: Co-Primary Safety Endpoint: Rates of Adverse Events
timeFrame: 120-180 days postoperative
measure: Co-Primary Safety Endpoint: Incidence of all SAE
timeFrame: 120-180 days postoperative
measure: Co-Primary Safety Endpoint: Rate of SSI Related to Optical Properties of the IOL
timeFrame: 120-180 days postoperative
measure: Primary Performance Endpoint: Mean Distance Corrected Intermediate Visual Acuity
timeFrame: 120-180 days postoperative
measure: Co-Primary Performance Endpoint: Cumulative Distance Corrected Intermediate Visual Acuity
timeFrame: 120-180 days postoperative
measure: Co-Primary Performance Endpoint: Monocular best-corrected distance defocus
timeFrame: 120-180 days postoperative
Secondary outcomes:
measure: Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data
timeFrame: 120-180 days postoperative
measure: Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)
timeFrame: 120-180 days postoperative
measure: Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)
timeFrame: 120-180 days postoperative
Other outcomes:
measure: Binocular best-corrected distance defocus
timeFrame: 120-180 days postoperative
measure: Manifest refraction
timeFrame: Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Adjusted Mean Refractive Spherical Equivalent (MRSE)
timeFrame: 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
timeFrame: Preoperative, 1-2 days postoperative; 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
timeFrame: Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Monocular Corrected Distance Visual Acuity (low contrast CDVA) using low contrast (10%) optotypes under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Monocular Uncorrected Intermediate Visual Acuity (UIVA) under photopic light conditions
timeFrame: 30-60 days postoperative, 120-180 days postoperative
measure: Binocular Uncorrected Intermediate Visual Acuity (UIVA) under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Binocular Uncorrected Near Visual Acuity (UNVA) under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions
timeFrame: 30-60 days postoperative, 120-180 days postoperative
measure: Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under mesopic light conditions
timeFrame: 120-180 days postoperative
measure: Monocular Distance Corrected Intermediate Visual Acuity (low contrast DCIVA) using low contrast (10%) optotypes under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Binocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Subject Symptom Assessment
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Patient reported outcomes - Quality of Vision questionnaire
timeFrame: 30-60 days postoperative, 120-180 days postoperative
measure: Patient reported outcomes - Catquest-9SF 2011 questionnaire
timeFrame: 30-60 days postoperative, 120-180 days postoperative
measure: Pupil Size under photopic light conditions
timeFrame: preoperative, 120-180 days postoperative
measure: Pupil Size under mesopic light conditions
timeFrame: preoperative, 120-180 days postoperative
measure: Fundus examination with dilated pupil
timeFrame: preoperative, 120-180 days postoperative
measure: Slitlamp examination - Corneal status
timeFrame: Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slitlamp examination - Iris status
timeFrame: Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slitlamp examination - Signs of inflammation
timeFrame: Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slitlamp examination - Pupillary block
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slitlamp examination - Retinal detachment
timeFrame: preoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slitlamp examination - Status of anterior and posterior capsule
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slitlamp examination - IOL decentration
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slitlamp examination - IOL tilt
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slitlamp examination - IOL discoloration
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slitlamp examination - IOL opacity
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Intraocular pressure (IOP) measurement
timeFrame: Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Keratometry
timeFrame: Preoperative
measure: IOL power
timeFrame: during surgery
measure: Target refraction
timeFrame: during surgery
measure: Fundus OCT
timeFrame: Preoperative
measure: Biometry
timeFrame: Preoperative
measure: Corneal topography
timeFrame: Preoperative
measure: Corneal aberrometry
timeFrame: Preoperative
measure: Halo and glare scores
timeFrame: 30-60 days postoperative
Locations:
city: Vienna
country: Austria
facility: Univ.-Klinik fuer Augenheilkunde und Optometrie
city: Vyškov
country: Czechia
facility: Gemini Eye Clinic Vyškov
city: Zlín
country: Czechia
facility: Gemini Eye Clinic Zlín
city: Ahaus
country: Germany
facility: Augenklinik Ahaus
city: Bochum
country: Germany
facility: Univ.-Klinikum Knappschaftskrankenhaus Bochum
city: Makati City
country: Philippines
facility: Asian Eye Institute
state: Manila
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
name: Burkhard Dick, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.