Status:
TERMINATED
Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients
Lead Sponsor:
Sensimed AG
Collaborating Sponsors:
University Hospital, Geneva
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This clinical trial is designed to investigate the performance of SENSIMED Triggerfish® during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid recording intervals over th...
Eligibility Criteria
Inclusion
- Older than 18 years.
- Untreated IOP of ≥22 mmHg in both eyes.
- Documented, typical glaucomatous visual field (VF) loss (nasal step, or arcuate, paracentral or Seidel's scotoma) determined by automated static threshold perimetry (Octopus 100), and glaucomatous optic nerve head cupping (neural rim notching or saucerization) in both eyes.
- Patients under tafluprost treatment since at least 4 weeks in both eyes.
- Patients who accept signing an informed consent approved by the Ethics Committee.
Exclusion
- Patients not able to understand the nature of the research
- Patients under tutorship
- Corneal abnormalities in both eyes
- Subjects with contraindications for wearing contact lenses
- History of ocular surgery within the last 3 months
- Known hypersensitivity to tafluprost or to any of its excipients
- Full-frame metal glasses during monitoring with SENSIMED Triggerfish®
- Pregnancy and lactation
- Simultaneous participation in other clinical research
- Patients with evidence of ocular infection or inflammation
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01263535
Start Date
September 1 2010
End Date
May 1 2012
Last Update
August 28 2012
Active Locations (1)
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1
University Hospital Geneva
Geneva, Switzerland, 1211