NCT04465344

Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens

Multicentric Clinical Study to Determine Safety and Efficacy of a Hydrophobic Acrylic Trifocal Intraocular Lens (IOL)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Cutting Edge SAS · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery.

Detailed description

This is a staged, multicentric, controlled, prospective, open-label clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of hydrophobic acrylic refractive trifocal intraocular lenses (Isatis TF) or the monofocal control device Isatis. The investigational device, Control lens 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. The study will be carried out in up to five clinical centers in Spain. The device under investigation is a hydrophobic acrylic trifocal intraocular lens (IOL) manufactured by the sponsor of this study. The trifocality of this investigational device is based on a purely refractive principle with the goal to provide additional near and intermediate visual acuity with low photic side effects. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development. The control device (Isatis) is a hydrophobic acrylic monofocal intraocular lens to be implanted during cataract surgery. This control lens is CE approved and commercially available in Spain. Isatis monofocal lens is the parent lens of the device under investigation and both lenses share mechanical and material properties. In total 180 patients will be recruited for this clinical study and undergo bilateral implantation of the Isatis TF intraocular lens or Isatis lens in a 2:1 ratio. Subjects participating in the trial will attend a total of maximum 11 study visits over a period of 11-13 months. Subjects would have the option for unscheduled visits if required medically. Data analyses will be performed after the last patient finished the 120-180 days postoperative examination.

Conditions

• Cataract
• Lens Opacities

Interventions

Type	Name	Description
DEVICE	Implantation of trifocal IOL, Isatis TF (device under investigation)	Patients will be implanted with study IOL in both eyes
DEVICE	Implantation of monofocal IOL, Isatis (control device)	Patients will be implanted with Control IOL in both eyes

Timeline

• Start date: 2021-05-31
• Primary completion: 2024-06-27
• Completion: 2024-06-27
• First posted: 2020-07-10
• Last updated: 2025-02-12

Locations

7 sites across 2 countries: Czechia, Spain