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

NCT01828255 | Terminated Results

• 1 other identifier: TF-1212
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  24-hour

Secondary Outcomes (4)

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

  24-hour

• Relationship Between TF Pattern and VF Progression According to Day and Night

  24-hour

• Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak

  24-hour

• 24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression

  24-hour

Study Arms (1)

SENSIMED Triggerfish®

EXPERIMENTAL

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®

Interventions

SENSIMED Triggerfish® DEVICE

SENSIMED Triggerfish®

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensimed AG: lead

Study Sites (1)

The New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Dr Gustavo De Moraes
• Organization: The New York Eye and Ear Infirmary

demoraesmd@gmail.com

+1 212 477 7540

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 10, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-09

Locations

US (1)