IOP Patterns in Fast Versus Slow Visual Field Progression Patients

This study is currently recruiting participants.
Verified July 2013 by Sensimed AG
Sponsor:
Information provided by (Responsible Party):
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01828255
First received: April 5, 2013
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Primary Open-angle Glaucoma Patient
Device: SENSIMED Triggerfish®

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: SENSIMED Triggerfish®

  Eligibility

Ages Eligible for Study:   40 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01828255

Contacts
Contact: Jessica Jasien, M.En +1 212 477 7540 ext 371 jjasien.ganyresearch@gmail.com
Contact: Gustavo De Moraes, MD +1 212 477 7540 demoraesmd@gmail.com

Locations
United States, New York
The New York Eye and Ear Infirmary Recruiting
New York, New York, United States, 10003
Contact: Jessica Jasien, M.En.    212-477-7540 ext 371    jjasien.ganyresearch@gmail.com   
Contact: Gustavo De Moraes, MD    +1 212-477-7540    demoraesmd@gmail.com   
Principal Investigator: Gustavo De Moraes, MD         
Sponsors and Collaborators
Sensimed AG
Investigators
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
  More Information

No publications provided

Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01828255     History of Changes
Other Study ID Numbers: TF-1212
Study First Received: April 5, 2013
Last Updated: July 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014