Surgical Treatment of Refractory Open Angle Glaucoma

Not Applicable

Completed

• Conditions: Open Angle Glaucoma
• Interventions: Device: Suprachoroidal Dissection Instrument (SDI)

• Registration Number: NCT01212861
• Lead Sponsor: iScience Interventional Corporation

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-09-30
• Study First Posted: 2010-10-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-11
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suprachoroidal Dissection Instrument	Suprachoroidal Dissection Instrument (SDI)	-

Primary Outcome Measures

Name	Time	Method
Postoperative intraocular pressure, glaucoma medication usage, and visual acuity	12 months

Trial Locations

Locations (1)

Glaucoma Associates of Texas; 🇺🇸 Dallas, Texas, United States