NCT03499821

Clinical Performance of a Phakic Intraocular Lens (IOL)

A Multicenter Clinical Evaluation of the Clinical Performance of a Phakic Intraocular Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Staar Surgical Company · Industry
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the clinical performance of a phakic intraocular lens (IOL) for the improvement of Uncorrected Near Visual Acuity (UCNVA) in subjects who require between +1.00 and +2.50 Reading Add.

Detailed description

This is a prospective, open-labeled, multi-site evaluation of clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens (VICL) with Aspheric (EDOF) Optic \[EDOF ICL\] for the improvement of UCNVA in subjects who require between +1.00 and +2.50 Reading Add. Approximately 48 subjects who meet all eligibility criteria will undergo EDOF ICL implantation in both eyes. All eyes will be followed for 6 months after surgery. The first eye implanted with the study lens and the appropriate time for fellow eye implantation will be determined by the medical judgement of the Investigator. All eyes will be analyzed for safety and performance. The primary performance endpoint is defined as achievement of monocular UCNVA of Snellen equivalent 20/40 or better at 40 cm at 6 months after implantation in equal to or greater than 75% of implanted eyes.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	EDOF ICL	The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Timeline

• Start date: 2018-03-20
• Primary completion: 2019-07-09
• Completion: 2019-07-09
• First posted: 2018-04-17
• Last updated: 2026-03-16
• Results posted: 2022-09-21

Locations

6 sites across 2 countries: Belgium, Spain

Regulatory

• FDA-regulated device study