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IOP Patterns in Fast Versus Slow Visual Field Progression Patients

This study has been terminated.
(Low recruitment rate)
Sponsor:
Information provided by (Responsible Party):
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01828255
First received: April 5, 2013
Last updated: May 12, 2014
Last verified: May 2014

April 5, 2013
May 12, 2014
March 2013
May 2014   (final data collection date for primary outcome measure)
Relationship between 24-hour IOP pattern as recorded by TF and VF progression in patients with POAG. [ Time Frame: 24-hour ] [ Designated as safety issue: No ]
Difference of the 24-hour IOP pattern as recorded by TF between patients with POAG with fast and slow rates of VF progression
Same as current
Complete list of historical versions of study NCT01828255 on ClinicalTrials.gov Archive Site
  • Relationship between 24-hour IOP pattern as recorded by TF and VF progression in patients with POAG. [ Time Frame: 24-hours ] [ Designated as safety issue: No ]
    Wake-sleep slope and sleep-wake slope
  • Relationship between 24-hour IOP pattern as recorded by TF and VF progression in patients with POAG. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Diurnal and nocturnal pattern
  • Relationship between 24-hour IOP pattern as recorded by TF and VF progression in patients with POAG. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Number of peaks
  • 24-hour IOP pattern as recorded by TF between patients with POAG with fast and slow rates of VF progression [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Relationship between the 24-hour IOP fluctuations and 24-hour blood pressure pattern
Relationship between 24-hour IOP pattern as recorded by TF and VF progression in patients with POAG. [ Time Frame: 24-hours ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
IOP Patterns in Fast Versus Slow Visual Field Progression Patients
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

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®, a portable investigational device using a contact lens sensor. After completing the Triggerfish lens placement and removal; the patient will complete a formal Polysomnography.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Primary Open-angle Glaucoma Patient
Device: SENSIMED Triggerfish®
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®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 40 and 89 years old
  • Diagnosis of treated POAG (including 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 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
Both
40 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01828255
TF-1212
No
Sensimed AG
Sensimed AG
Not Provided
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
Sensimed AG
May 2014

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