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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral implantation of LuxSmart hydrophobic IOL | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes | Device | Extended depth of field intraocular lens made form hydrophobic material |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pavel Stodulka | Gemini Eye Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemini Eye Clinic | Zlín | 760 01 | Czechia |
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| 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 |