Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery

• Sponsor: Glaukos Corporation (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01455467
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 87
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma	Device: One iStent; Device: Two iStent	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery
• Study Start Date: Sep 1, 2011
• Anticipated Primary Completion Date: Jun 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: One iStent Implantation of one iStent in conjunction with cataract surgery	Device: One iStent; Implantation of one iStent in conjunction with cataract surgery
Active Comparator: Two iStent Implantation of two iStent devices in conjunction with cataract surgery	Device: Two iStent; Implantation of two iStent in conjunction with cataract surgery

Outcome Measures

Primary Outcome Measures

1. Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP [12 Months]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation

• Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)

Exclusion Criteria:

• Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)

• Prior stent implantations (study eye)

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: NCT01455467
• Other Study ID Numbers: GCF-024
• First Posted: Oct 20, 2011
• Last Update Posted: Mar 9, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by Glaukos Corporation: Open angle glaucoma; Pigmentary glaucoma; Pseudoexfoliative glaucoma
• Additional relevant MeSH terms: Glaucoma; Cataract; Glaucoma, Open-Angle

Study Results

No Results Posted as of Mar 9, 2018