NCT03255785

Brief Summary

Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

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

August 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2019

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

1.6 years

First QC Date

August 17, 2017

Last Update Submit

September 6, 2022

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

  • 20% IOP reduction from baseline

    IOP measured via Goldmann tonometry in mm Hg and compared to baseline IOP

    Month 12

Secondary Outcomes (1)

  • IOP less than or equal to 18 mm Hg

    Month 12

Study Arms (1)

G1 plus G3 with phaco

EXPERIMENTAL

Cataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra

Device: Cataract surgery plus one iStent and one iStent Supra implanted

Interventions

Cataract surgery plus one iStent and one iStent Supra implantedDEVICE

Cataract surgery via phacoemulsfication plus one iStent and one iStent supra

G1 plus G3 with phaco

Eligibility Criteria

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

You may qualify if:

  • Clinically significant cataract requiring surgery Primary open-angle or pseudoexfoliative glaucoma Visual field defects no worse than -12dB Subject on two ocular hypotensive medications at screening Medicated IOP at screening between 18 and 30 mm Hg Normal iridocorneal anatomy Absence of peripheral anterior synechiae

You may not qualify if:

  • Monocular subjects or those with wore than 20/200 vision in fellow eye Prior stent implantation, incision glaucoma surgery, or laser trabeculoplasty in study eye Traumatic, uveitic, or neovascular glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaukos Investigator Sites

Yerevan, Armenia

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
IOP outcome masked
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: iStent and iStent Supra
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 21, 2017

Study Start

May 1, 2018

Primary Completion

December 3, 2019

Study Completion

December 3, 2019

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)