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

NCT ID: NCT01828255

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-05-31

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.

Conditions

Primary Open-angle Glaucoma (POAG) Patient

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SENSIMED Triggerfish®

Intervention Type: DEVICE

Interventions

SENSIMED Triggerfish®

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sensimed AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gustavo De Moraes, MD

Role: PRINCIPAL_INVESTIGATOR

The New York Eye and Ear Infirmary

Jeffrey M Liebmann, MD

Role: PRINCIPAL_INVESTIGATOR

The New York Eye and Ear Infirmary

Robert Ritch, MD

Role: PRINCIPAL_INVESTIGATOR

The New York Eye and Ear Infirmary

Locations

The New York Eye and Ear Infirmary

New York, New York, United States

Countries

United States

Other Identifiers

TF-1212

Identifier Type: -

Identifier Source: org_study_id