NCT02487160

Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 499 (actual)
• Sponsor: Lenstec Incorporated · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular lens.

Detailed description

The purpose of this study is to evaluate the safety (adverse events) and performance (visual acuity, spectacle independence) of the SBL-3 intraocular lens.

Conditions

• Cataracts
• Presbyopia

Interventions

Type	Name	Description
DEVICE	SBL-3 multifocal intraocular lens	The SBL-3 intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group
DEVICE	Control monofocal intraocular lens	The Control intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group

Timeline

• Start date: 2015-08-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2015-07-01
• Last updated: 2023-05-23

Locations

13 sites across 1 country: United States