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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

Tracking Information
First Submitted Date  ICMJE April 5, 2013
First Posted Date  ICMJE April 10, 2013
Results First Submitted Date  ICMJE November 17, 2015
Results First Posted Date  ICMJE October 9, 2020
Last Update Posted Date October 9, 2020
Study Start Date  ICMJE March 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG. [ Time Frame: 24-hour ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG. [ Time Frame: 24-hour ]
Difference of the 24-hour IOP pattern as recorded by TF between patients with POAG with fast and slow rates of VF progression
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • Relationship Between TF Pattern and VF Progression According to TF Slope [ Time Frame: 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 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.
  • Relationship Between TF Pattern and VF Progression According to Day and Night [ Time Frame: 24-hour ]
    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.
  • Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak [ Time Frame: 24-hour ]
    Number of peaks in 24-Hours TF pattern, defined as the local maximum point in the smoothed TF profile.
  • 24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression [ Time Frame: 24-hour ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
Relationship between 24-hour IOP pattern as recorded by TF and VF progression in patients with POAG. [ Time Frame: 24-hour ]
Wake-sleep slope and sleep-wake slope Diurnal and nocturnal pattern Number of peaks Relationship between the 24-hour IOP fluctuations and 24-hour blood pressure pattern
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients
Official Title  ICMJE A Single Center, Case-control, Open Label Study Assessing Intraocular Pressure Patterns in Patients With Primary Open-angle Glaucoma Experiencing Fast Versus Slow Visual Field Progression
Brief Summary The purpose of this study is to investigate how the intraocular pressure (IOP) varies in time and if the IOP variations are associated with the worsening of glaucoma. IOP patterns will be recorded continuously over 24 hours with SENSIMED Triggerfish® (TF) a portable investigational device using a contact lens sensor. After completing the Triggerfish lens placement and removal; the patient will complete a formal Polysomnography.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Primary Open-angle Glaucoma (POAG) Patient
Intervention  ICMJE Device: SENSIMED Triggerfish®
Study Arms  ICMJE Experimental: SENSIMED Triggerfish®
Device: portable device that monitors the 24-hour IOP pattern by a wireless contact lens sensor placed on the eye that sends its signals via an antenna around the orbital cavity to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization.
Intervention: Device: SENSIMED Triggerfish®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 12, 2014)
40
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2013)
60
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 40 and 89 years old
  • Diagnosis of treated POAG (including normal tension glaucoma (NTG))
  • All IOP measurements during the VF period (to be described further) equal or lower than 18 mmHg and/or on average equal or lower than 16 mmHg in the same period
  • Documented glaucomatous VF damage at baseline, characterized by glaucoma hemifield test result outside normal limits on at least 2 consecutive VF tests or the presence of at least 3 contiguous test points within the same hemifield on the pattern deviation plot at p<0.01, with at least 1 point at p < 0.005
  • At least 8 visual field tests carried out within at least 2 years, all with fixation losses and false positive/negative results equal or less than 33%
  • For fast progressing eyes, 1) 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 2) a global rate of VF change based on mean deviation (MD) more negative than -1.0 dB/year
  • For slowly or minimally progressing eyes a VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression as described above
  • Not more than 6 diopters spherical equivalent on the study eye
  • Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

  • Baseline VF MD more negative than -15 dB. The rationale here is that in severely damaged visual fields, one may not be able to detect and measure rates of progression due to a 'floor effect'
  • Corneal or conjunctival abnormality precluding contact lens adaptation
  • Severe dry eye syndrome or other ocular disease
  • Patients with angle closure glaucoma, traumatic glaucoma or uveitic glaucoma
  • Patients with previous intraocular surgery in the enrolled eye, including cataract surgery
  • Patients with allergy to corneal anesthetic
  • Patients with contraindications for silicone contact lens wear
  • Patients not able to understand the character and individual consequences of the investigation
  • Participation in unrelated clinical research within the last 4 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01828255
Other Study ID Numbers  ICMJE TF-1212
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sensimed AG
Study Sponsor  ICMJE Sensimed AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gustavo De Moraes, MD The New York Eye and Ear Infirmary
Principal Investigator: Jeffrey M Liebmann, MD The New York Eye and Ear Infirmary
Principal Investigator: Robert Ritch, MD The New York Eye and Ear Infirmary
PRS Account Sensimed AG
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP