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Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients

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ClinicalTrials.gov Identifier: NCT01828255
Recruitment Status : Terminated (Low recruitment rate)
First Posted : April 10, 2013
Results First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Sensimed AG

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Primary Open-angle Glaucoma (POAG) Patient
Intervention Device: SENSIMED Triggerfish®
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fast Progressors Slow Progressors
Hide Arm/Group Description pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year VF MD rate of change more positive than -0.5 dB/year with no significant point defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01wise progression
Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Slow Progressors Fast Progressors Total
Hide Arm/Group Description VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression defined as two or more adjacent VF test locations in the same hemifield pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
65.4  (8.3) 68.3  (8.6) 67  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
15
  75.0%
12
  60.0%
27
  67.5%
Male
5
  25.0%
8
  40.0%
13
  32.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
Visual field defect   [1] 
Mean (Standard Deviation)
Unit of measure:  dB
Number Analyzed 20 participants 20 participants 40 participants
-0.07  (0.12) -1.88  (0.48) -0.98  (1.3)
[1]
Measure Description: Visual field is measured by perimetry and the mean defect (MD) is assesses the defect in the visual field.
1.Primary Outcome
Title Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.
Hide Description 24-hour measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression.
Time Frame 24-hour
Hide Outcome Measure Data
Hide Analysis Population Description
POAG patients with slow or fast rate of VF glaucoma progression
Arm/Group Title Fast Progressors Slow Progressors
Hide Arm/Group Description:
Patients with a fast rate of progression (<-1dB/y)
Patients with a slow rate of progression (>-1dB/y)
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: mVeq
410.1  (138.4) 334.6  (119.4)
2.Secondary Outcome
Title Relationship Between TF Pattern and VF Progression According to TF Slope
Hide Description Measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression during wake vs sleep periods. The wake slope corresponds to the change in the TF signal from 1 hour before to 1 hour after the time the subject went to sleep. The sleep slope corresponds to the change from 1 hour before to 1 hour after the time the subject awoke.
Time Frame 24-hour
Hide Outcome Measure Data
Hide Analysis Population Description
POAG patients with slow or fast rate of VF glaucoma progression
Arm/Group Title Fast Slow
Hide Arm/Group Description:
Pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year
VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression defined as two or more adjacent VF test locations in the same hemifield
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: mVeq/hour
Wake slope 34.9  (55.7) 34.6  (44.3)
Sleep slope -33.5  (44.6) -35.7  (61.9)
3.Secondary Outcome
Title Relationship Between TF Pattern and VF Progression According to Day and Night
Hide Description TF measurement during diurnal and nocturnal periods and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression.
Time Frame 24-hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fast Slow
Hide Arm/Group Description:
Pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year
VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression defined as two or more adjacent VF test locations in the same hemifield
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: mVeq
Diurnal 84.0  (37.2) 93.9  (40.6)
Nocturnal 30.8  (9.6) 42.3  (16.0)
4.Secondary Outcome
Title Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak
Hide Description Number of peaks in 24-Hours TF pattern, defined as the local maximum point in the smoothed TF profile.
Time Frame 24-hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fast Slow
Hide Arm/Group Description:
Pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year
VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression defined as two or more adjacent VF test locations in the same hemifield
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: Number of peaks
13.1  (3.0) 14.1  (4.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fast, Slow
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title 24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression
Hide Description Comparison (Spearman correlations) between 24-hour IOP-related fluctuations measured by TF and 24-hour blood pressure profiles (systolic, diastolic and mean arterial blood pressure) of POAG patients showing fast and slow rates of glaucoma visual field progression. The correlation between TF and blood pressure measurement was calculated within each subject then mean values were obtained for patients with slow vs fast glaucoma visual field progression.
Time Frame 24-hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fast Slow
Hide Arm/Group Description:
Pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year
VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression defined as two or more adjacent VF test locations in the same hemifield
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: coefficient of correlation
Systolic blood pressure -0.08  (0.32) -0.19  (0.32)
Diastolic blood pressure -0.06  (0.36) -0.22  (0.30)
Mean arterial blood pressure -0.06  (0.35) -0.21  (0.28)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fast Progressors Slow Progressors
Hide Arm/Group Description Pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression defined as two or more adjacent VF test locations in the same hemifield
All-Cause Mortality
Fast Progressors Slow Progressors
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Fast Progressors Slow Progressors
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fast Progressors Slow Progressors
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/20 (0.00%)    
Eye disorders     
Corneal abrasion  1/20 (5.00%)  1 0/20 (0.00%)  0
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
Layout table for Results Point of Contact information
Name/Title: Dr Gustavo De Moraes
Organization: The New York Eye and Ear Infirmary
Phone: +1 212 477 7540
EMail: demoraesmd@gmail.com
Layout table for additonal information
Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01828255    
Other Study ID Numbers: TF-1212
First Submitted: April 5, 2013
First Posted: April 10, 2013
Results First Submitted: November 17, 2015
Results First Posted: October 9, 2020
Last Update Posted: October 9, 2020