NCT01444105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2019

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

7.6 years

First QC Date

September 28, 2011

Last Update Submit

August 29, 2022

Conditions

Open-angle Glaucoma

Keywords

Open angle glaucomaPseudoexfoliative glaucoma

Outcome Measures

Primary Outcomes (1)

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

    12 Months

Study Arms (2)

iStent

ACTIVE COMPARATOR

implantation of two iStent devices

Device: iStent

SLT

ACTIVE COMPARATOR

Laser treatment

Other: SLT

Interventions

iStentDEVICE

Implantation of two iStent devices

iStent
SLTOTHER

Laser treatment

SLT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Aphakic or pseudophakic with anterior chamber IOLs (AC-IOLs) (study eye)
  • Prior stent implantations (study eye)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.V. Malayan Ophthalmological Center

Yerevan, 0001, Armenia

Location

Related Publications (1)

  • Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

    PMID: 35943114DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Lilit A Voskanyan, MD, PhD

    S.V. Malayan Ophthalmological Center, Yerevan, Armenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2011

First Posted

September 30, 2011

Study Start

September 1, 2011

Primary Completion

April 9, 2019

Study Completion

April 9, 2019

Last Updated

August 31, 2022

Record last verified: 2022-08

Locations

AR(1)