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Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yvonne Buys, University of Toronto
ClinicalTrials.gov Identifier:
NCT01263561
First received: December 14, 2010
Last updated: December 7, 2014
Last verified: December 2014
Results First Received: December 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Procedure: ExPRESS shunt
Procedure: trabeculectomy

  Participant Flow
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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
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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  
Number of Participants  
[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
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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
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  More Information
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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


No publications provided


Responsible Party: Yvonne Buys, University of Toronto
ClinicalTrials.gov Identifier: NCT01263561     History of Changes
Other Study ID Numbers: 07-0888-A
Study First Received: December 14, 2010
Results First Received: December 1, 2014
Last Updated: December 7, 2014
Health Authority: Canada: Ethics Review Committee