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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01444105

Enrollment

Registered

2011-09-30

Start date

2011-09-30

Completion date

2019-04-09

Last updated

2022-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-angle Glaucoma

Keywords

Open angle glaucoma, Pseudoexfoliative glaucoma

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.

Interventions

DEVICEiStent

Implantation of two iStent devices

OTHERSLT

Laser treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Countries

Armenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026