Status:
COMPLETED
Surgical Treatment of Refractory Open Angle Glaucoma
Lead Sponsor:
iScience Interventional Corporation
Conditions:
Open Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 suprachoroida...
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 ...
Eligibility Criteria
Inclusion
- Available for up to 3 years follow-up.
- Diagnosed with primary open-angle, pseudoexfoliative, or pigmentary glaucoma or more than one glaucoma diagnosis of these types.
- Subject scheduled to undergo glaucoma surgery with the Suprachoroidal Dissection Instrument involving creation of fistula between Schlemm's canal and the suprachoroidal space without combined cataract surgery.
- Subject has failed at least one incisional glaucoma surgery (trabeculectomy, tube shunt, deep sclerectomy, viscocanalostomy, canaloplasty) or angle surgery (Trabectome) OR Is not a candidate for conventional glaucoma surgery due to reasons such as the presence of scleral buckle or compromised conjunctiva.
- Subject has IOP ≥ 16 mm Hg on maximally tolerated medications within the six week (-42 days) period prior to surgery.
- Visual field defect defined as mean deviation (MD) score worse than or equal to -10 dB on the Swedish Interactive Threshold Algorithm \[SITA\] Standard 24-2 Humphrey Analysis during the 6 month period prior to surgery. OR Subject has vertical cup-to-disk ratio ≥ 0.75 during the 6 month period prior to surgery.
Exclusion
- Significant lens opacities or patient is candidate for cataract surgery during the duration of the study.
- The patient had developmental glaucoma or a secondary glaucoma including steroid-induced, uveitic, or neovascular glaucoma (with the exception of pigmentary and pseudoexfoliative glaucoma).
- The patient has narrow angle component possibly associated with glaucoma in the operative eye.
- The subject has angle recession in the operative eye.
- Significant ocular disease other than glaucoma affecting the assessment of visual function.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01212861
Start Date
August 1 2010
End Date
May 1 2012
Last Update
September 12 2012
Active Locations (1)
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1
Glaucoma Associates of Texas
Dallas, Texas, United States, 75231