Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents

• Sponsor: Glaukos Corporation (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01456390
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 81
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma	Device: iStent and iStent supra	N/A

Detailed Description

Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Evaluation of Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents and a Postoperative Prostaglandin
• Actual Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Feb 1, 2017
• Anticipated Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: iStent and iStent supra Implantation of two iStent devices and one iStent supra device	Device: iStent and iStent supra; Implantation of two iStent devices and one iStent supra device

Outcome Measures

Primary Outcome Measures

1. Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP [12 Months]

   Primary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP, had no glaucoma surgical procedures (incisional or laser surgery prior to the 12 month visit), and no postoperative procedure to reposition or remove the stent prior to the 12 month visit, or additional ocular hypotensive medications within 4 weeks of the Month 12 visit

Secondary Outcome Measures

1. Mean diurnal IOP < 18mm Hg [12 months]

   Secondary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP < 18 mmHg, had no glaucoma surgical procedures (incisional or laser surgery) prior to the 12 month visit, and no postoperative procedure to reposition or remove the stent prior to the 12 month visit or additional ocular hypotensive medications within 4 weeks of the Month 12 visit

Other Outcome Measures

1. Safety/adverse event monitoring [0-61 months]

   Rate of ocular adverse events through 61 months Findings from IOP, best corrected visual acuity, visual field, specular microscopy measurements Findings from slit-lamp, fundus and gonioscopic examinations

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)

• Open-angle glaucoma (including pseudoexfoliative)

Exclusion Criteria:

• Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)

• Prior ALT

• Prior SLT within 90 days of screening visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	S.V. Malayan Ophthalmological Center	Yerevan		Armenia	0001

Sponsors and Collaborators

• Glaukos Corporation

Investigators

• Principal Investigator: Lilit A Voskanyan, MD, PhD, S.V. Malayan Ophthalmological Center, Yerevan, Armenia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Glaukos Corporation
• ClinicalTrials.gov Identifier: NCT01456390
• Other Study ID Numbers: GCF-023
• First Posted: Oct 20, 2011
• Last Update Posted: Dec 18, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by Glaukos Corporation: Open angle glaucoma; Prior trabeculectomy
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

No Results Posted as of Dec 18, 2017