Clinical trial NCT01828255: 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
Overall status: TERMINATED
Phase: NA
Conditions: Primary Open-angle Glaucoma (POAG) Patient
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2013-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.
timeFrame: 24-hour
Secondary outcomes:
measure: Relationship Between TF Pattern and VF Progression According to TF Slope
timeFrame: 24-hour
measure: Relationship Between TF Pattern and VF Progression According to Day and Night
timeFrame: 24-hour
measure: Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak
timeFrame: 24-hour
measure: 24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression
timeFrame: 24-hour
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Eye and Ear Infirmary
state: New York
Study officials:
affiliation: The New York Eye and Ear Infirmary
name: Gustavo De Moraes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The New York Eye and Ear Infirmary
name: Jeffrey M Liebmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The New York Eye and Ear Infirmary
name: Robert Ritch, MD
role: PRINCIPAL_INVESTIGATOR
References: