A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System

Cataract Clinical Trial

Official title: A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System

Status Completed

Clinical Trial Summary

This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification.

Clinical Trial Description

This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification to evaluate safety and effectiveness. The primary effectiveness endpoint is a complete capsulotomy in at least 95 percent of the cases. The primary safety endpoint is posterior capsular rupture and virtuous loss in 4 percent or less of the subjects. Other parameters to be captured during the study include anterior capsule tears, corneal touch, capsulotomy diameter, contraption of the Zepto capsulotomy, size of the corneal incision pre and post Zepto, interocular lens contraption and evaluation of zonular stability and the incidence and severity of adverse events. The criteria for patient success will be accessed based on the successful completion of a 360 degree capsulotomy without tissue bridges and no posterior capsule rupture and vitreous loss. The criteria for study success will be accessed based on a greater than or equal to 95 percent of the cases having a complete 360 degree capsulotomy without tissue bridges and less than 4 percent of subjects with posterior capsule rupture and vitreous loss. ;

Related Conditions & MeSH terms

• Cataract

• NCT number: NCT02890303
• Study type: Interventional
• Source: Mynosys Cellular Devices, Inc.
• Status: Completed
• Phase: N/A
• Start date: September 12, 2016
• Completion date: March 14, 2017