Clinical Trial: Surgical Treatment of Refractory Open Angle Glaucoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Surgical Treatment of Refractory Open Angle Glaucoma - A Prospective, Open-Label, Pilot Study
Brief 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 Summary: 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.
Sponsor: iScience Interventional Corporation
Current Primary Outcome: Postoperative intraocular pressure, glaucoma medication usage, and visual acuity [ Time Frame: 12 months ]
Original Primary Outcome:
- Postoperative intraocular pressure [ Time Frame: Up to 36 months ]
- Glaucoma medication use [ Time Frame: Up to 36 months ]
- Visual acuity [ Time Frame: Up to 36 months ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: iScience Interventional Corporation
Dates:
Date Received: September 29, 2010
Date Started: August 2010
Date Completion:
Last Updated: September 11, 2012
Last Verified: September 2012
