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NCT00323284 · ClinicalTrials.gov registry record · Phase 3

A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma

A Phase 3 study, sponsored by Glaukos Corporation.

Completed
Registry status
Phase 3
Development phase
240
Enrollment target

NCT00323284: Completed Phase 3 study, sponsored by Glaukos Corporation.

NCT00323284 is a Phase 3 study that has completed, run by Glaukos Corporation. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00323284, a Phase 3 study, has completed, sponsored by Glaukos Corporation.

COMPLETED
Registry status
Phase 3
Development phase
240 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

Primary Outcome

Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months

Interventions

  • DEVICE iStent plus Cataract Surgery
  • PROCEDURE Cataract surgery only

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2005-06
Est. Completion 2010-03
Phase Phase 3
Glaukos Corporation

33 total trials

What the finished NCT00323284 record still lists

NCT00323284 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 2 interventions - of which iStent plus Cataract Surgery is the first listed.

NCT00323284 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00323284 about?

NCT00323284 is a clinical study titled "A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma". The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

What is the current status of trial NCT00323284?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2005-06. Estimated completion is 2010-03.

What interventions are being tested in trial NCT00323284?

The interventions under investigation include: iStent plus Cataract Surgery (DEVICE), Cataract surgery only (PROCEDURE).

Who is sponsoring clinical trial NCT00323284?

This trial is sponsored by Glaukos Corporation, which has 33 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00323284's enrollment target sits among peer trials

240 1273rd of 2000 higher than 710 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00323284, the US trial registry maintained by the National Library of Medicine. NCT00323284 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.