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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01253109

Enrollment

Registered

2010-12-03

Start date

2010-09-30

Completion date

2011-11-30

Last updated

2012-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pigmentary Dispersion Syndrome, Pigmentary Glaucoma Patients

Brief summary

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.

Interventions

DEVICESENSIMED Triggerfish

Contact lens-based device for continuous IOP monitoring

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
SENSIMED Triggerfish output values	during 4 to 6 hours	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
Goldmann Applanation Tonometry values	During 4 to 6 hours	GAT IOP readings will be done in the other eye at regular intervals during 4 to 6 hours SENSIMED Triggerfish IOP monitoring

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026