Evaluation of the Extended Depth of Focus After Bilateral Implantation of Hydrophobic IOLs

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cataract Senile

Intervention / Treatment
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* Device: Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral implantation of LuxSmart hydrophobic IOL<br>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<br>* Extended depth of field intraocular lens made form hydrophobic material<br>|

What is the study measuring?
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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 |