24h Continuous Intraocular Pressure (IOP) Monitoring vs Goldmann Applanation Tonometry

NCT01217853 | Completed

• 1 other identifier: 09/10
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

A study in which intraocular pressure (IOP) will be monitored over 24 hours using the SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle glaucoma patients. The aim of this study is to investigate the comparability of diurnal IOP patterns emerging from SENSIMED Triggerfish and GAT.

Conditions

Primary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (2)

• SENSIMED Triggerfish output values

  Patients will undergo one session of 24-hour SENSIMED Triggerfish continuous intraocular pressure monitoring in one eye.

  During 24 hours

• Goldmann applanation tonometry values

  Goldmann applanation IOP readings will be done in the other eye at regular intervals during 24-hour SENSIMED Triggerfish IOP monitoring and in both eyes during another 24-hour session.

  During 24 hours

Study Arms (1)

SENSIMED Triggerfish

Device: SENSIMED Triggerfish

Interventions

SENSIMED Triggerfish DEVICE

Contact lens-based device for continuous intraocular pressure monitoring

SENSIMED Triggerfish

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male or female patients 40 to 70 years old and diagnosed with primary open angle glaucoma.

You may qualify if:

• Signed informed consent for the investigation
• Patients with primary open angle glaucoma (POAG), defined as open angle ≥ 30°, confirmed visual field loss (Mean Defect/Least Variance ≤ 2dB) and/or optic nerve head damage (cup disc ratio \> 0,5)
• Not more than 4 diopters spherical equivalent on the study eye
• Not more than 2 diopters cylinder equivalent on the study eye
• For women of childbearing potential, adequate contraception
• Stable anti-glaucomatous therapy 4 weeks before the first 24-hour IOP assessment session and throughout the investigation

You may not qualify if:

• Patients not able to understand the character and individual consequences of the investigation
• Patients committed to an institution by virtue of an order issued either by the courts or by an authority
• Absence of or withdrawn informed consent
• Patients with contraindications for silicone contact lens wear
• Wear of full frame metallic glasses during SENSIMED Triggerfish monitoring
• Eye disorders including severe dry eye
• Eye disorders secondary to POAG
• Patient who have had ocular surgery within the last 3 months
• Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
• Pregnancy and lactation
• Allergy to oxybuprocaine (ocular anesthesia)
• Simultaneous participation in other clinical research

Sponsors & Collaborators

• Sensimed AG: lead
• Schlossparkklinik: collaborator

Study Sites (2)

Schlosspark-Klinik

Berlin, 14059, Germany

Location

Johannes Gutenberg Universitätsklinik Mainz

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Carl Erb, Prof

  Schlosspark-Klinik Berlin

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 8, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 3, 2011

Record last verified: 2011-08

Locations

DE (2)