Continuous Intraocular Pressure (IOP) Monitoring in Pigmentary Dispersion Syndrome and Pigmentary Glaucoma Patients

Sensimed

Status: Terminated

Conditions: Pigmentary Dispersion Syndrome; Pigmentary Glaucoma Patients

Treatments: Device: SENSIMED Triggerfish

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01253109

09/11

Details and patient eligibility

About

This study monitors the intraocular pressure (IOP) over 4 to 6 hours using the SENSIMED Triggerfish® device and Goldmann Applanation Tonometry (GAT) in pigment dispersion syndrome and pigmentary glaucoma patients. The aim of the study is to detect SENSIMED Triggerfish® output signal peak after induced fluctuation by physical exercise or pupil dilation.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes
• IOP of ≥ 15 mmHg
• 18-60 years.
• Patients able to jog continuously for at least 25 minutes
• Phakic eyes
• Patients who accept signing an informed consent approved by the Ethics Committee.

Exclusion criteria

• Pigmentary glaucoma already treated with peripheral laser iridotomy (PLI), argon laser peripheral iridoplasty (ALPI), argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT) in any eye
• Patients treated with pilocarpine or other mydriatic agent within the last 4 weeks in any eye
• Anti-hypertensive treatment in the 4 weeks preceding the study and throughout the study. Following signature of informed consent, anti-hypertensive treatment will be washed out for 4 weeks prior to study procedures in enrolled patients
• Patients with pseudoexfoliative (PEX) syndrome or PEX glaucoma in any eye
• Patients not able to understand the nature of the research
• Patients under tutorship
• Corneal abnormality
• Subjects with contraindications for wearing contact lenses
• Full frame metal glasses during SENSIMED Triggerfish® monitoring
• History of other ocular surgery except uncomplicated strabismus surgery no later than 3 months prior to study procedures
• Ocular inflammation or infection
• History of cardiac or pulmonary disorder
• Pregnancy and lactation
• Simultaneous participation in other clinical research

Trial design

15 participants in 1 patient group

SENSIMED Triggerfish

Treatment:

Device: SENSIMED Triggerfish