Status:
TERMINATED
Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients
Lead Sponsor:
Sensimed AG
Conditions:
Primary Open-angle Glaucoma (POAG) Patient
Eligibility:
All Genders
40-89 years
Phase:
NA
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 con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01828255
Start Date
March 1 2013
End Date
May 1 2014
Last Update
October 9 2020
Active Locations (1)
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1
The New York Eye and Ear Infirmary
New York, New York, United States, 10003