We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01263561
First Posted: December 20, 2010
Last Update Posted: December 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yvonne Buys, University of Toronto
Results First Submitted: December 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Procedure: ExPRESS shunt
Procedure: trabeculectomy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Trabeculectomy

trabeculectomy filtering surgery

trabeculectomy: trabeculectomy filtering surgery

ExPRESS

ExPRESS miniature glaucoma drainage device

ExPRESS shunt: ExPRESS miniature glaucoma drainage device


Participant Flow:   Overall Study
    Trabeculectomy   ExPRESS
STARTED   31   33 
COMPLETED   30   31 
NOT COMPLETED   1   2 
Death                1                2 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Trabeculectomy

trabeculectomy filtering surgery

trabeculectomy: trabeculectomy filtering surgery

ExPRESS

ExPRESS miniature glaucoma drainage device

ExPRESS shunt: ExPRESS miniature glaucoma drainage device

Total Total of all reporting groups

Baseline Measures
   Trabeculectomy   ExPRESS   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   33   64 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.9  (11.5)   62  (13.9)   63.9  (12.7) 
Gender 
[Units: Participants]
     
Female   10   13   23 
Male   21   20   41 
intraocular pressure 
[Units: mmHg]
Mean (Standard Deviation)
 22  (6.8)   22.6  (10.2)   22.3  (8.6) 
glaucoma medications 
[Units: Number of medications]
Mean (Standard Deviation)
 3.4  (1.3)   3.5  (.9)   3.5  (1.1) 
visual acuity 
[Units: logMAR]
Mean (Standard Deviation)
 .48  (.6)   .42  (.6)   .44  (.56) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Intraocular Pressure   [ Time Frame: 1 year post surgery ]

2.  Primary:   Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication   [ Time Frame: 1 year post surgery ]

3.  Secondary:   Complications   [ Time Frame: 1 year post surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Yvonne Buys
Organization: Department of Ophthalmology and Vision Sciences, University of Toronto
phone: 416-603-5682
e-mail: y.buys@utoronto.ca


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yvonne Buys, University of Toronto
ClinicalTrials.gov Identifier: NCT01263561     History of Changes
Other Study ID Numbers: 07-0888-A
First Submitted: December 14, 2010
First Posted: December 20, 2010
Results First Submitted: December 1, 2014
Results First Posted: December 9, 2014
Last Update Posted: December 9, 2014