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OpenTrials
Completed

NCT Number: NCT03065036

Safety and Efficacy Study of the Hydrus Aqueous Implant in Subjects With POAG

The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Medical Center Vienna, Vienna, Austria

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About this study

This is a prospective, multi-center study that will examine subjects with documented mild to advanced primary open angle glaucoma (POAG), who may or may not have a cataract requiring removal and placement of an intraocular lens.

Study subjects will be grouped by the severity of their disease (either mild/moderate or advanced). If all inclusion and exclusion criteria are met subjects in all four groups will be implanted with the Hydrus Aqueous Implant. Subjects in whom a cataract is present will undergo standard cataract removal and IOL implantation concurrent with implantation of the Hydrus.

Postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elevated intraocular pressure (IOP)
  • Diagnosis of mild to advanced open-angle glaucoma
  • Shaffer Grade III
  • Mental capacity to cooperate when undergoing operative and postoperative examination
  • 18 years of age or older
  • Provide written informed consent
  • Willing and able to return to scheduled follow-up examinations for 24-months

Exclusion criteria

  • Closed-angle and narrow-angle forms of glaucoma
  • Secondary glaucomas
  • Congenital or developmental glaucoma

Treatment and study plan

prestudy topical glaucoma medications

Drug

Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.

Primary outcomes

  1. Change in IOP of study eye between each randomized group

    Time frame: Baseline & One year

    Effectiveness will be determined by comparing the IOP at the baseline (pre-operative) visit to the the IOP at the 12 month post-operative visit.

Secondary outcomes

  1. Change in glaucoma medications

    Time frame: Baseline & One year

    Calculate the change in the number of glaucoma medications from baseline (pre-operative) visit to the 12-month post-operative visit.

Sponsors and collaborators

Lead sponsor

Ivantis, Inc.

Industry

Registry information

Official study title

A Prospective, Multi-Center Evaluation of the Hydrus Aqueous Implant (Standard and Low-Profile) for Lowering Intraocular Pressure (IOP) in Subjects With Mild to Advanced Primary Open Angle Glaucoma (POAG) With or Without a Cataract

Acronym: POAG

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Feb 27, 2017
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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