NCT01517477

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2019

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

7.8 years

First QC Date

January 23, 2012

Last Update Submit

August 29, 2022

Conditions

Primary Open Angle Glaucoma (POAG)

Keywords

Open angleGlaucomasurgeryGlaucoma, Open-AngleOcular HypertensionEye Diseases

Outcome Measures

Primary Outcomes (1)

  • Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline

    12 Months

Secondary Outcomes (1)

  • Mean diurnal IOP <18 mmHg at month 12

    12 months

Study Arms (3)

First Arm: One iStent

EXPERIMENTAL

Device: One iStent

Device: iStent

Second Arm: Two iStents

EXPERIMENTAL

Device: Two iStent devices

Device: iStent

Third Arm: Three iStents

EXPERIMENTAL

Device: Three iStent devices

Device: iStent

Interventions

iStentDEVICE

Implantation of One iStent through a small temporal clear corneal incision.

First Arm: One iStent

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 two topical hypotensive medications

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

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucomaOcular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 25, 2012

Study Start

January 1, 2012

Primary Completion

October 18, 2019

Study Completion

October 18, 2019

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

18 month results published in Clinical Ophthalmology 2015:9 2313-2320.

Locations

AR(1)