Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2010-08-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Suprachoroidal Dissection Instrument
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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iScience Interventional Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ronald Fellman, MD
Role: PRINCIPAL_INVESTIGATOR
Glaucoma Associates of Texas
Locations
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Glaucoma Associates of Texas
Dallas, Texas, United States
Countries
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Other Identifiers
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060410
Identifier Type: -
Identifier Source: org_study_id