NCT01212861

Surgical Treatment of Refractory Open Angle Glaucoma

Surgical Treatment of Refractory Open Angle Glaucoma - A Prospective, Open-Label, Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: iScience Interventional Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety, efficacy, and performance of the Suprachoroidal Dissection Instrument in creating a fistula between Schlemm's canal and the suprachoroidal space in refractory, open angle glaucoma subjects.

Detailed description

The Suprachoroidal Dissection Instrument (SDI) is a manually operated surgical instrument designed for use within Schlemm's canal. The instrument can access Schlemm's canal through a small ab-externo dissection, allowing use in eyes with scarring due to previous surgery or trauma.

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Suprachoroidal Dissection Instrument (SDI)	The Suprachoroidal Dissection Instrument (SDI) is a manually operated, non-powered, re-usable ophthalmic surgical instrument. The SDI is designed to enter a surgically exposed Schlemm's canal and be advanced up to 90 degrees around the canal from the entry site.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-10-01
• Last updated: 2012-09-12

Locations

1 site across 1 country: United States