Central Corneal Thickness With SENSIMED Triggerfish

Glaucoma Clinical Trial

— 09/08  

Official title:

Central Corneal Thickness After Overnight IOP Monitoring With SENSIMED Triggerfish

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210963
• Other study ID #: 09/08
• Status: Completed
• Phase: N/A
• First received: September 27, 2010
• Last updated: March 17, 2011
• Start date: September 2010
• Est. completion date: February 2011

Study information

• Verified date: March 2011
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Device:
• SENSIMED Triggerfish
Contact lens-based Sensor with recording system for continuous monitoring of IOP fluctuation

Locations

Country	Name	City	State
Germany	Augen- und Poliklinik, Universitätsklinikum Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pachymetry (central corneal thickness)		after 8 hours nocturnal continuous IOP monitoring	No