Surgical Treatment of Refractory Open Angle Glaucoma

NCT01212861 | Completed

• 1 other identifier: 060410
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Postoperative intraocular pressure, glaucoma medication usage, and visual acuity

  12 months

Study Arms (1)

Suprachoroidal Dissection Instrument

EXPERIMENTAL

Device: Suprachoroidal Dissection Instrument (SDI)

Interventions

Suprachoroidal Dissection Instrument (SDI) DEVICE

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.

Also known as: SDI

Suprachoroidal Dissection Instrument

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iScience Interventional Corporation: lead

Study Sites (1)

Glaucoma Associates of Texas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Ronald Fellman, MD

  Glaucoma Associates of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: October 1, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 12, 2012

Record last verified: 2012-09

Locations

US (1)