09/08: Central Corneal Thickness With SENSIMED Triggerfish

• Sponsor: Sensimed AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01210963
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Device: SENSIMED Triggerfish

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Central Corneal Thickness After Overnight IOP Monitoring With SENSIMED Triggerfish
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
SENSIMED Triggerfish	Device: SENSIMED Triggerfish; Contact lens-based Sensor with recording system for continuous monitoring of IOP fluctuation

Outcome Measures

Primary Outcome Measures

1. Pachymetry (central corneal thickness) [after 8 hours nocturnal continuous IOP monitoring]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Augen- und Poliklinik, Universitätsklinikum Würzburg	Würzburg		Germany	97080

Sponsors and Collaborators

• Sensimed AG

Investigators

• Principal Investigator: Thomas Klink, PD Dr. med, Wuerzburg University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01210963
• Other Study ID Numbers: 09/08
• First Posted: Sep 29, 2010
• Last Update Posted: Mar 18, 2011
• Last Verified: Mar 1, 2011

• Additional relevant MeSH terms: Ocular Hypertension

Study Results

No Results Posted as of Mar 18, 2011