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

Pigmentary Dispersion Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01253109
• Other study ID #: 09/11
• Status: Terminated
• Phase: N/A
• First received: December 2, 2010
• Last updated: January 23, 2012
• Start date: September 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Pigmentary Dispersion Syndrome
• Pigmentary Glaucoma Patients
• Syndrome

Intervention

Device:
• SENSIMED Triggerfish
Contact lens-based device for continuous IOP monitoring

Locations

Country	Name	City	State
Switzerland	Private practice - Dr Sunaric Mégevand	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
Sensimed AG	Orasis, AugenZentrum Pajic, Private practicioner, Dr Sunaric Mégevand

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No