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Surgical Treatment of Refractory Open Angle Glaucoma

This study has been completed.
Information provided by (Responsible Party):
iScience Interventional Corporation Identifier:
First received: September 29, 2010
Last updated: September 11, 2012
Last verified: September 2012
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.

Condition Intervention
Open Angle Glaucoma Device: Suprachoroidal Dissection Instrument (SDI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Treatment of Refractory Open Angle Glaucoma - A Prospective, Open-Label, Pilot Study

Resource links provided by NLM:

Further study details as provided by iScience Interventional Corporation:

Primary Outcome Measures:
  • Postoperative intraocular pressure, glaucoma medication usage, and visual acuity [ Time Frame: 12 months ]

Enrollment: 4
Study Start Date: August 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01212861

United States, Texas
Glaucoma Associates of Texas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
iScience Interventional Corporation
Principal Investigator: Ronald Fellman, MD Glaucoma Associates of Texas
  More Information

Responsible Party: iScience Interventional Corporation Identifier: NCT01212861     History of Changes
Other Study ID Numbers: 060410
Study First Received: September 29, 2010
Last Updated: September 11, 2012

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases processed this record on September 20, 2017