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

NCT01253109 | Terminated

• 1 other identifier: 09/11
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pigmentary Dispersion Syndrome; Pigmentary Glaucoma Patients

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

SENSIMED Triggerfish

Device: SENSIMED Triggerfish

Interventions

SENSIMED Triggerfish DEVICE

Contact lens-based device for continuous IOP monitoring

SENSIMED Triggerfish

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes

You may qualify if:

• Confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes
• IOP of ≥ 15 mmHg
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Private practice - Dr Sunaric Mégevand

Geneva, 1206, Switzerland

Location

Study Officials

• Gordana Sunaric Megevand, Dr

  Private Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 3, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 24, 2012

Record last verified: 2012-01

Locations

CH (1)