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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-11-30

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.

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Detailed Description

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Conditions

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Pigmentary Dispersion Syndrome Pigmentary Glaucoma Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SENSIMED Triggerfish

Intervention Type DEVICE

Contact lens-based device for continuous IOP monitoring

Interventions

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SENSIMED Triggerfish

Contact lens-based device for continuous IOP monitoring

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No