NCT01455467

Brief Summary

Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

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

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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
22 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
8 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

8.1 years

First QC Date

September 28, 2011

Last Update Submit

August 29, 2022

Conditions

Open-angle Glaucoma

Keywords

Open angle glaucomaPigmentary glaucomaPseudoexfoliative glaucoma

Outcome Measures

Primary Outcomes (1)

  • Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP

    12 Months

Study Arms (2)

One iStent

ACTIVE COMPARATOR

Implantation of one iStent in conjunction with cataract surgery

Device: One iStent

Two iStent

ACTIVE COMPARATOR

Implantation of two iStent devices in conjunction with cataract surgery

Device: Two iStent

Interventions

One iStentDEVICE

Implantation of one iStent in conjunction with cataract surgery

One iStent
Two iStentDEVICE

Implantation of two iStent in conjunction with cataract surgery

Two iStent

Eligibility Criteria

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

You may qualify if:

  • Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
  • Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)

You may not qualify if:

  • Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or 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

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2011

First Posted

October 20, 2011

Study Start

September 1, 2011

Primary Completion

October 18, 2019

Study Completion

October 18, 2019

Last Updated

August 31, 2022

Record last verified: 2022-08

Locations

AR(1)