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

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

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.

Condition or disease	Intervention/treatment	Phase
Primary Open-angle Glaucoma (POAG) Patient	Device: SENSIMED Triggerfish®	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: March 2013
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2014

Arms and Interventions

Arm	Intervention/treatment
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®

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

The New York Eye and Ear Infirmary

New York, New York, United States, 10003

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

• Responsible Party: Sensimed AG
• ClinicalTrials.gov Identifier: NCT01828255
• Other Study ID Numbers: TF-1212
• First Posted: April 10, 2013
• Results First Posted: October 9, 2020
• Last Update Posted: October 9, 2020
• Last Verified: September 2020

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Eye Diseases