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Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01798966
First Posted: February 26, 2013
Last Update Posted: March 11, 2016
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.
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Sensimed AG
Results First Submitted: December 4, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Thyroid Eye Disease
Intervention: Device: SENSIMED Triggerfish

  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
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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
SENSIMED Triggerfish All patients included in the device group

Participant Flow:   Overall Study
    SENSIMED Triggerfish
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  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.
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Reporting Groups
  Description
SENSIMED Triggerfish All patients included in the device group

Baseline Measures
   SENSIMED Triggerfish 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.8  (21.6) 
Gender 
[Units: Participants]
 
Female   9 
Male   1 
Region of Enrollment 
[Units: Participants]
 
United States   10 
Tolerability of CLS [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.5  (0.7) 
[1] Subjective comfort level using a number between 0-10 with values ranging from 0 (no discomfort) to 10 (very severe discomfort)


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in IOP Before and After Orbital Decompression Surgery   [ Time Frame: 24 hours ]

2.  Secondary:   IOP Patterns   [ Time Frame: 24 hours ]

3.  Other Pre-specified:   Adverse Events and Serious Adverse Events   [ Time Frame: 4 days ]


  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: Anjali Parekh
Organization: Hamilton Glaucoma center
phone: +1858 822-1553
e-mail: anjalism@gmail.com



Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01798966     History of Changes
Other Study ID Numbers: TF-1111
First Submitted: February 21, 2013
First Posted: February 26, 2013
Results First Submitted: December 4, 2014
Results First Posted: March 2, 2015
Last Update Posted: March 11, 2016