Gemini Eye Clinic
Zlín, 760 01, Czechia
NCT Number: NCT04523558
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.
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Not applicable
Zlín, 760 01, Czechia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Extended depth of field intraocular lens made form hydrophobic material
Time frame: 6 months
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
Standard refraction technique
Time frame: 6 months
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
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
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
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
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye
Time frame: 6 months
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes
Time frame: 6 months
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye
Time frame: 6 months
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes
Time frame: 6 months
Standard defocus curve with -5.0 to +1.5 D range lenses
Time frame: 6 months
Measurement of contrast sensitivity at 2.5 m
Time frame: 6 months
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
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".
Gemini Eye Clinic
Industry
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
Acronym: LuxSmart
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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