Evaluation of the Extended Depth of Focus After Bilateral Implantation of Hydrophobic IOLs (LuxSmart)

Evaluation of the Extended Depth of Focus After Bilateral Implantation of a Hydrophobic IOL With a New Optic Concept Based on a Combination of High Order Aberrations

This will be a prospective observational, ethics committee approved study where patients undergoing routine cataract surgery will have bilateral implantation of the intraocular lens (LuxSmart, Bausch & Lomb). The device under investigation is CE-mark approved and commercially available. The device under investigation and all study products, including the 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 patient.

Investigator is accredited and experienced cataract surgeon and researchers who have been involved in similar studies in the past.

The device under investigation LuxSmart (Bausch & Lomb) is a hydrophobic, acrylic copolymer containing UV absorber intraocular lens (IOL). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 30 patients will be recruited for this first clinical experience and receive bilateral implantation of the LuxSmart. The maximum time between 1st and 2nd eye implantation is 30 days, some patients may receive bilateral implantation on the same day. However there will be a minimum of 1 week between the implantations in the first 10 patients.

Study Overview

• Status: Completed
• Conditions: Cataract Senile
• Intervention / Treatment: Device: Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Zlín, Czechia, 760 01
    • Gemini Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cataractous eyes with no comorbidity;
• Calculated IOL power is within the range of the study IOLs;
• Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;
• Regular corneal astigmatism ≤1.5D (measured by an automatic keratometry) in one or both eyes;
• Clear intraocular media other than cataract;
• Dilated pupil size large enough to visualize IOL axis markings postoperatively
• Availability, willingness, skills and cognitive awareness enough to comply with the follow-up/study procedures and study visits.
• Subjects able to read, understand and provide written Informed Consent Form on the Ethics Committee approved Informed Consent Form and provide authorization as appropriate for local privacy regulations.

Exclusion Criteria:

• Age of patient <50 years;
• Regular corneal astigmatism >1.5D (measured by an automatic keratometry) in both eyes;
• Irregular astigmatism;
• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
• Subjects with AMD suspicious eyes as determined by OCT examination;
• Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
• Previous intraocular or corneal surgery;
• Traumatic cataract;
• History or presence of macular edema;
• Instability of keratometry or biometry measurements;
• Advanced or decompensated glaucoma;
• Significant dry eye;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bilateral implantation of LuxSmart hydrophobic IOL; Cataract surgery will be carried out using standard phacoemulsification technique with a 2.2 mm incision. Investigators will target a 5.5 mm diameter capsulorhexis to allow the optic to be fully overlapped by the anterior capsular rim. The intended target of the post-operative refraction will be emmetropia. The patient will be implanted with LuxSmart hydrophobic IOLs in both eyes and followed up for 6 months

Device: Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes; Extended depth of field intraocular lens made form hydrophobic material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected Distance Visual Acuity	Measurement of distance visual acuity is measured with 5 letters modified Snellen charts placed at 6 m distance with corrective glasses for each eye separately	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manifest refraction (sphere, cylinder, axis)	Standard refraction technique	6 months
Monocular Uncorrected Distance Visual Acuity (UDVA)	Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance without corrective glasses for each eye separately	6 months
Binocular Uncorrected Distance Visual Acuity (UDVA)	Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance without corrective glasses for both eyes together	6 months
Monocular Corrected Distance Visual Acuity (CDVA)	Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance with corrective glasses for each eye separately	6 months
Binocular Corrected Distance Visual Acuity (CDVA)	Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance with corrective glasses for both eyes together	6 months
Monocular Uncorrected Intermediate Visual Acuity (UIVA)	Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye	6 months
Binocular Uncorrected Intermediate Visual Acuity (UIVA)	Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes	6 months
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)	Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye	6 months
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)	Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes	6 months
Monocular Defocus Curve	Standard defocus curve with -5.0 to +1.5 D range lenses	6 months
Monocular Contrast Sensitivity under photopic and mesopic conditions	Measurement of contrast sensitivity at 2.5 m	6 months
Change in the 9-item Catquest short-form questionnaire (Catquest-9SF) score	To assess if difficulties in daily life occur due to impaired sight. This questionnaire is 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery. There are five text response options for the answers scaled from "Yes, very great difficulties" to "No, no difficulties" including answer "Cannot decide". Outcome is a sum score (min: 9, max: 36, lower scores mean a better result)	6 months
Overall Spectacle independence	Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ - "a little of the time" or "none of the time".	6 months

Collaborators and Investigators

• Sponsor: Gemini Eye Clinic
• Investigators: Principal Investigator: Pavel Stodulka, Gemini Eye Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 8, 2021

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: LuxSmart_2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No