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Completed

NCT Number: NCT01263561

Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome: IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from baseline without medication or additional glaucoma surgery and qualified success defined as IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication but no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications, visual acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital

Toronto, Ontario, M5T 2S8, Canada

About this study

Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 18 to 85
  • open-angle glaucoma uncontrolled medically
  • intraocular pressure ≥ 18 mmHg
  • trabeculectomy as the planned surgical procedure

Exclusion criteria

  • any previous ocular incisional surgery with the exception of previous clear
  • cornea cataract surgery
  • uveitis
  • vitreous present in anterior chamber
  • patient unwilling or unable to accept randomization or to give consent or to attend the follow up visits

Treatment and study plan

ExPRESS shunt

Procedure

ExPRESS miniature glaucoma drainage device

trabeculectomy

Procedure

trabeculectomy filtering surgery

Primary outcomes

  1. Intraocular Pressure

    Time frame: 1 year post surgery

  2. Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication

    Time frame: 1 year post surgery

Secondary outcomes

  1. Complications

    Time frame: 1 year post surgery

    Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2010
Registry last updated
Dec 9, 2014

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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