IOP Patterns in Fast Versus Slow Visual Field Progression Patients
| Status: | Terminated |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 40 - 89 |
| Updated: | 10/14/2017 |
| Start Date: | March 2013 |
| End Date: | May 2014 |
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
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®, a portable investigational
device using a contact lens sensor. After completing the Triggerfish lens placement and
removal; the patient will complete a formal Polysomnography.
and if the IOP variations are associated with the worsening of glaucoma. IOP patterns will be
recorded continuously over 24 hours with SENSIMED Triggerfish®, a portable investigational
device using a contact lens sensor. After completing the Triggerfish lens placement and
removal; the patient will complete a formal Polysomnography.
Inclusion Criteria:
- Age between 40 and 89 years old
- Diagnosis of treated POAG (including 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
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
We found this trial at
1
site
Click here to add this to my saved trials
