Surgical Treatment of Refractory Open Angle Glaucoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
iScience Interventional Corporation
ClinicalTrials.gov Identifier:
NCT01212861
First received: September 29, 2010
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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: 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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212861

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

No publications provided

Responsible Party: iScience Interventional Corporation
ClinicalTrials.gov Identifier: NCT01212861     History of Changes
Other Study ID Numbers: 060410
Study First Received: September 29, 2010
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 26, 2014