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

• Sponsor: Sensimed AG (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01253109
• Collaborator: Private practicioner, Dr Sunaric Mégevand (Other), Orasis, AugenZentrum Pajic (Other)
• Enrollment: 15
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pigmentary Dispersion Syndrome; Pigmentary Glaucoma Patients	Device: SENSIMED Triggerfish

Study Design

• Study Type: Observational
• Anticipated Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Detection of Induced IOP Fluctuations by SENSIMED Triggerfish® in Pigmentary Syndrome and Glaucoma Patients
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
SENSIMED Triggerfish	Device: SENSIMED Triggerfish; Contact lens-based device for continuous IOP monitoring

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Private practice - Dr Sunaric Mégevand	Geneva		Switzerland	1206

Sponsors and Collaborators

• Sensimed AG
• Private practicioner, Dr Sunaric Mégevand
• Orasis, AugenZentrum Pajic

Investigators

• Principal Investigator: Gordana Sunaric Megevand, Dr, Private Practice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01253109
• Other Study ID Numbers: 09/11
• First Posted: Dec 3, 2010
• Last Update Posted: Jan 24, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Syndrome

Study Results

No Results Posted as of Jan 24, 2012