Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents

NCT ID: NCT01456390

Last Updated: 2022-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2019-03-26

Brief Summary

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Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Detailed Description

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Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Conditions

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Open-Angle Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iStent and iStent supra

Implantation of two iStent devices and one iStent supra device

Group Type OTHER

iStent and iStent supra

Intervention Type DEVICE

Implantation of two iStent devices and one iStent supra device

Interventions

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iStent and iStent supra

Implantation of two iStent devices and one iStent supra device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
* Open-angle glaucoma (including pseudoexfoliative)

Exclusion Criteria

* Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
* Prior ALT
* Prior SLT within 90 days of screening visit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaukos Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lilit A Voskanyan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

S.V. Malayan Ophthalmological Center, Yerevan, Armenia

Locations

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S.V. Malayan Ophthalmological Center

Yerevan, , Armenia

Site Status

Countries

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Armenia

References

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Myers JS, Masood I, Hornbeak DM, Belda JI, Auffarth G, Junemann A, Giamporcaro JE, Martinez-de-la-Casa JM, Ahmed IIK, Voskanyan L, Katz LJ. Prospective Evaluation of Two iStent(R) Trabecular Stents, One iStent Supra(R) Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes. Adv Ther. 2018 Mar;35(3):395-407. doi: 10.1007/s12325-018-0666-4. Epub 2018 Feb 23.

Reference Type DERIVED
PMID: 29476443 (View on PubMed)

Other Identifiers

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GCF-023

Identifier Type: -

Identifier Source: org_study_id

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