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

Study Overview
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Brief Summary
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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.

Official Title
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Detection of Induced IOP Fluctuations by SENSIMED Triggerfish® in Pigmentary Syndrome and Glaucoma Patients

Conditions
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Pigmentary Dispersion Syndrome, Pigmentary Glaucoma Patients

Intervention / Treatment
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* Device: SENSIMED Triggerfish


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SENSIMED Triggerfish<br> | Device: SENSIMED Triggerfish<br>* Contact lens-based device for continuous IOP monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SENSIMED Triggerfish output values | Patients will undergo 2 sessions of 4 to 6 hours SENSIMED Triggerfish continuous intraocular pressure monitoring in a selected eye, during and/or after physical exercise and pupile dilation | during 4 to 6 hours | 
| Goldmann Applanation Tonometry values | GAT IOP readings will be done in the other eye at regular intervals during 4 to 6 hours SENSIMED Triggerfish IOP monitoring | During 4 to 6 hours |