TerminatedNot Applicable

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

Stopped: Law agreement between Triggerfish signal and GAT IOP during both sessions. However, an increase in the Triggerfish signal was observed during jogging phase.

Switzerland15 participantsStarted 2010-09

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SENSIMED Triggerfish output values

Timeframe: during 4 to 6 hours

Goldmann Applanation Tonometry values

Timeframe: During 4 to 6 hours

Trial details

NCT IDNCT01253109

SponsorSensimed AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-11

View on ClinicalTrials.gov More Pigmentary Dispersion Syndrome trials