NCT01252862

Brief Summary

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_4

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

First Submitted

Initial submission to the registry

December 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 18, 2017

Status Verified

December 1, 2017

Enrollment Period

5.6 years

First QC Date

December 1, 2010

Last Update Submit

December 14, 2017

Conditions

Subjects With Primary Open-angle Glaucoma (POAG)

Keywords

Open angleGlaucomaSurgeryOcular Hypertensioneye diseases

Outcome Measures

Primary Outcomes (1)

  • Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs baseline

    12 Months

Secondary Outcomes (1)

  • IOP < 18 mm Hg at Month 12

    12 months

Study Arms (1)

Two iStents devices

EXPERIMENTAL

Two iStents devices will be implanted

Device: iStent

Interventions

iStentDEVICE

Implantation of two iStents through a small temporal clear corneal incision

Two iStents devices

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with primary open-angle glaucoma (POAG)
  • Subject on one topical hypotensive medication

You may not qualify if:

  • Traumatic, uveitic, neovascular, or angle closure glaucoma
  • Fellow eye already enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.V. Malayan's Ophthalmology Centre

Yerevan, 375108, Armenia

Location

Related Publications (1)

  • Donnenfeld ED, Solomon KD, Voskanyan L, Chang DF, Samuelson TW, Ahmed II, Katz LJ. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma. Clin Ophthalmol. 2015 Nov 3;9:2057-65. doi: 10.2147/OPTH.S91732. eCollection 2015.

    PMID: 26604675BACKGROUND

MeSH Terms

Conditions

GlaucomaOcular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 3, 2010

Study Start

December 1, 2010

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

December 18, 2017

Record last verified: 2017-12

Locations

AR(1)