Surgical Treatment of Refractory Open Angle Glaucoma
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Surgical Treatment of Refractory Open Angle Glaucoma - A Prospective, Open-Label, Pilot Study|
- Postoperative intraocular pressure, glaucoma medication usage, and visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Experimental: Suprachoroidal Dissection Instrument||
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.
Other Name: SDI
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212861
|United States, Texas|
|Glaucoma Associates of Texas|
|Dallas, Texas, United States, 75231|
|Principal Investigator:||Ronald Fellman, MD||Glaucoma Associates of Texas|