Central Corneal Thickness With SENSIMED Triggerfish

Completed

• Conditions: Glaucoma; Ocular Hypertension

• Registration Number: NCT01210963
• Lead Sponsor: Sensimed AG

Brief Summary

Investigation of the occurrence of possible corneal swelling after continuous Intraocular pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-17
• Last Update Posted: 2011-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• glaucoma and ocular hypertension scheduled for overnight hospitalisation
• stable IOP-lowering treatment since at least 4 weeks before study
• at least 18 years
• having provided informed consent

Exclusion Criteria

• contact lens wear within the last 2 years
• contraindication for silicone lean wear
• corneal abnormality in either eye
• ocular infection or inflammation
• history of ocular surgery within the last 3 months
• full-frame metal glasses during IOP monitoring with SENSIMED Triggerfish
• pregnancy and lactation
• patients not able to understand the nature of the research
• patients under tutelage
• patients committed to an institution by virtue of an order issued either by the courts or by an authority
• simultaneous participation in other clinical research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pachymetry (central corneal thickness)	after 8 hours nocturnal continuous IOP monitoring

Trial Locations

Locations (1)

Augen- und Poliklinik, Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany