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

Terminated

• Conditions: Pigmentary Dispersion Syndrome; Pigmentary Glaucoma Patients

• Registration Number: NCT01253109
• Lead Sponsor: Sensimed AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-23
• Last Update Posted: 2012-01-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Private practice - Dr Sunaric Mégevand; 🇨🇭 Geneva, Switzerland