Clinical trial NCT04523558: Evaluation of the Extended Depth of Focus After Bilateral Implantation of Hydrophobic IOLs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Senile
Lead sponsor: Gemini Eye Clinic
Sponsor class: INDUSTRY
First posted: 2020-08-21
Enrollment: 33
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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;

Primary outcomes:
measure: Corrected Distance Visual Acuity
timeFrame: 6 months
Secondary outcomes:
measure: Manifest refraction (sphere, cylinder, axis)
timeFrame: 6 months
measure: Monocular Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 6 months
measure: Binocular Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 6 months
measure: Monocular Corrected Distance Visual Acuity (CDVA)
timeFrame: 6 months
measure: Binocular Corrected Distance Visual Acuity (CDVA)
timeFrame: 6 months
measure: Monocular Uncorrected Intermediate Visual Acuity (UIVA)
timeFrame: 6 months
measure: Binocular Uncorrected Intermediate Visual Acuity (UIVA)
timeFrame: 6 months
measure: Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)
timeFrame: 6 months
measure: Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
timeFrame: 6 months
measure: Monocular Defocus Curve
timeFrame: 6 months
measure: Monocular Contrast Sensitivity under photopic and mesopic conditions
timeFrame: 6 months
measure: Change in the 9-item Catquest short-form questionnaire (Catquest-9SF) score
timeFrame: 6 months
measure: Overall Spectacle independence
timeFrame: 6 months
Other outcomes:
Locations:
city: Zlín
country: Czechia
facility: Gemini Eye Clinic
Study officials:
affiliation: Gemini Eye Clinic
name: Pavel Stodulka
role: PRINCIPAL_INVESTIGATOR
References: