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Variability in Perimetry Study (VIPII)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01051739
First Posted: January 20, 2010
Last Update Posted: March 21, 2017
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):
VA Office of Research and Development
Results First Submitted: October 25, 2016  
Study Type: Observational
Study Design: Observational Model: Case-Control;   Time Perspective: Prospective
Condition: Glaucoma
Intervention: Procedure: Comparison of four visual field testing strategies

  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
We completed recruitment in the first three years of the grant period at out Visual Field Laboratory at the University of Iowa

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
see inclusion and exclusion criteria

Reporting Groups
  Description
Group 1 glaucoma patients
Group 2 normal ocular healthy controls

Participant Flow:   Overall Study
    Group 1   Group 2
STARTED   120   60 
COMPLETED   92   47 
NOT COMPLETED   28   13 
Death                3                3 
Withdrawal by Subject                25                10 



  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
Group 1 glaucoma with mean deviation from 0 to -25 dB
Group 2 normal - healthy observers with no eye pathology other than refractive error less than 6 diopters of correction.
Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 120   60   180 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      25  20.8%      41  68.3%      66  36.7% 
>=65 years      95  79.2%      19  31.7%      114  63.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 68  (9)   61  (9)   64  (9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      73  60.8%      43  71.7%      116  64.4% 
Male      47  39.2%      17  28.3%      64  35.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   120   60   180 


  Outcome Measures

1.  Primary:   Number of Subjects Progressing in Each Group Using Pointwise Linear Regression   [ Time Frame: 4 years ]


  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
not all subjects completed the study (dropouts).


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael Wall, M.D.
Organization: Iowa City Veterans Administration Medical Center
phone: 319-3380581
e-mail: michael-wall@uiowa.edu


Publications of Results:
Other Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01051739     History of Changes
Other Study ID Numbers: C7098-R
First Submitted: January 15, 2010
First Posted: January 20, 2010
Results First Submitted: October 25, 2016
Results First Posted: February 10, 2017
Last Update Posted: March 21, 2017