NCT04523558

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Gemini Eye Clinic · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract Senile

Interventions

Type	Name	Description
DEVICE	Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes	Extended depth of field intraocular lens made form hydrophobic material

Timeline

• Start date: 2020-06-25
• Primary completion: 2021-04-01
• Completion: 2021-04-08
• First posted: 2020-08-21
• Last updated: 2023-04-19

Locations

1 site across 1 country: Czechia