NCT01210963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 18, 2011

Status Verified

March 1, 2011

Enrollment Period

5 months

First QC Date

September 27, 2010

Last Update Submit

March 17, 2011

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Pachymetry (central corneal thickness)

    after 8 hours nocturnal continuous IOP monitoring

Study Arms (1)

SENSIMED Triggerfish

Device: SENSIMED Triggerfish

Interventions

SENSIMED TriggerfishDEVICE

Contact lens-based Sensor with recording system for continuous monitoring of IOP fluctuation

SENSIMED Triggerfish

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Glaucoma and ocular hypertension patients, at least 18 years old and with stable IOP-lowering treatment (if any).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augen- und Poliklinik, Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Thomas Klink, PD Dr. med

    Wuerzburg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 29, 2010

Study Start

September 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 18, 2011

Record last verified: 2011-03

Locations

DE(1)