Clinical trial NCT01212861: Surgical Treatment of Refractory Open Angle Glaucoma
Official title: Surgical Treatment of Refractory Open Angle Glaucoma - A Prospective, Open-Label, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Lead sponsor: iScience Interventional Corporation
Sponsor class: INDUSTRY
First posted: 2010-10-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Postoperative intraocular pressure, glaucoma medication usage, and visual acuity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
Study officials:
affiliation: Glaucoma Associates of Texas
name: Ronald Fellman, MD
role: PRINCIPAL_INVESTIGATOR
References: