Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

Sponsor

Glaukos Corporation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01444105

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma	Device: iStent Other: SLT	N/A

Detailed Description

Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomized, Controlled, Parallel Groups Evaluation of Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

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: iStent implantation of two iStent devices	Device: iStent Implantation of two iStent devices
Active Comparator: SLT Laser treatment	Other: SLT Laser treatment

Arm

Intervention/Treatment

Active Comparator: iStent

implantation of two iStent devices

Device: iStent

Implantation of two iStent devices

Active Comparator: SLT

Laser treatment

Other: SLT

Laser treatment

Outcome Measures

Primary Outcome Measures

Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit. [12 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Phakic study eye or study eye with a posterior chamber intraocular lens (PC-IOL)
Primary open-angle glaucoma (including pseudoexfoliative)

Exclusion Criteria:

Aphakic or pseudophakic with anterior chamber IOLs (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:

NCT01444105

Other Study ID Numbers:

GCF-028

First Posted:

Sep 30, 2011

Last Update Posted:

Mar 9, 2018

Last Verified:

Mar 1, 2018

Keywords provided by Glaukos Corporation

Open angle glaucoma

Pseudoexfoliative glaucoma

Additional relevant MeSH terms:

Glaucoma

Glaucoma, Open-Angle

Study Results

No Results Posted as of Mar 9, 2018