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

Cataract Senile Clinical Trial

— LuxSmart  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523558
• Other study ID #: LuxSmart_2020
• Status: Completed
• Phase: N/A
• Start date: June 25, 2020
• Est. completion date: April 8, 2021

Study information

• Verified date: April 2023
• Source: Gemini Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 8, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Intervention

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

Locations

Country	Name	City	State
Czechia	Gemini Eye Clinic	Zlín

Sponsors (1)

Lead Sponsor	Collaborator
Gemini Eye Clinic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Manifest refraction (sphere, cylinder, axis)	Standard refraction technique	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Monocular Uncorrected Intermediate Visual Acuity (UIVA)	Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye	6 months
Secondary	Binocular Uncorrected Intermediate Visual Acuity (UIVA)	Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes	6 months
Secondary	Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)	Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye	6 months
Secondary	Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)	Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes	6 months
Secondary	Monocular Defocus Curve	Standard defocus curve with -5.0 to +1.5 D range lenses	6 months
Secondary	Monocular Contrast Sensitivity under photopic and mesopic conditions	Measurement of contrast sensitivity at 2.5 m	6 months
Secondary	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
Secondary	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