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

Gemini Eye Clinic33 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract Senile

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Manifest refraction (sphere, cylinder, axis)

Standard refraction technique

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 6 months

Monocular Uncorrected Intermediate Visual Acuity (UIVA)

Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye

Time frame: 6 months

Binocular Uncorrected Intermediate Visual Acuity (UIVA)

Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes

Time frame: 6 months

Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)

Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye

Time frame: 6 months

Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)

Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes

Time frame: 6 months

Monocular Defocus Curve

Standard defocus curve with -5.0 to +1.5 D range lenses

Time frame: 6 months

Monocular Contrast Sensitivity under photopic and mesopic conditions

Measurement of contrast sensitivity at 2.5 m

Time frame: 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)

Time frame: 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".

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes