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

Primary Purpose

Primary Open-angle Glaucoma (POAG) Patient

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SENSIMED Triggerfish®
Sponsored by
Sensimed AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Open-angle Glaucoma (POAG) Patient

Eligibility Criteria

40 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The New York Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SENSIMED Triggerfish®

Arm Description

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.

Outcomes

Primary Outcome Measures

Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.
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.

Secondary Outcome Measures

Relationship Between TF Pattern and VF Progression According to TF Slope
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
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
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
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.

Full Information

First Posted
April 5, 2013
Last Updated
September 15, 2020
Sponsor
Sensimed AG
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1. Study Identification

Unique Protocol Identification Number
NCT01828255
Brief Title
Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment rate
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sensimed AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma (POAG) Patient

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SENSIMED Triggerfish®
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
SENSIMED Triggerfish®
Primary Outcome Measure Information:
Title
Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.
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
Secondary Outcome Measure Information:
Title
Relationship Between TF Pattern and VF Progression According to TF Slope
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
Title
Relationship Between TF Pattern and VF Progression According to Day and Night
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
Title
Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak
Description
Number of peaks in 24-Hours TF pattern, defined as the local maximum point in the smoothed TF profile.
Time Frame
24-hour
Title
24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo De Moraes, MD
Organizational Affiliation
The New York Eye and Ear Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey M Liebmann, MD
Organizational Affiliation
The New York Eye and Ear Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Ritch, MD
Organizational Affiliation
The New York Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
The New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

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

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