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

Not Applicable

Completed

• Conditions: Open-angle Glaucoma
• Interventions: Device: iStent; Other: SLT

• Registration Number: NCT01444105
• Lead Sponsor: Glaukos Corporation

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.

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-30
• Primary Completion: 2019-04-09
• Study Completion: 2019-04-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iStent	iStent	implantation of two iStent devices
SLT	SLT	Laser treatment

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit.	12 Months

Trial Locations

Locations (1)

S.V. Malayan Ophthalmological Center; 🇦🇲 Yerevan, Armenia