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Use of an Ocular Telemetry Sensor in Diamox Treated Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028664
First Posted: December 9, 2009
Last Update Posted: December 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Clinique de Montchoisi, Lausanne, Switzerland
Information provided by:
Sensimed AG
  Purpose
A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to detect the induced IOP reduction.

Condition Intervention
Glaucoma Ocular Hypertension Device: SENSIMED Triggerfish

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Detection of IOP Fluctuation With SENSIMED Triggerfish in Patients With Glaucoma or Ocular Hypertension Treated With Diamox

Resource links provided by NLM:


Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • Detection of IOP reduction 2 hours after Diamox administration [ Time Frame: 2 hours ]

Estimated Enrollment: 20
Study Start Date: December 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glaucoma or ocular hypertension patients Device: SENSIMED Triggerfish
2-hour continuous IOP monitoring

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of glaucoma or ocular hypertension
  • IOP of ≥ 15 mmHg.
  • Patients of either gender.
  • Older than 18 years.
  • Patients who accept signing an informed consent approved by the Ethics Committee.

Exclusion Criteria:

  • Patients not able to understand the nature of the research
  • Patients under tutorship
  • Corneal abnormalities in both eyes
  • Subjects with contraindications for wearing contact lenses
  • History of ocular surgery within the last 3 months
  • Known hypersensitivity to Diamox® or to any of its excipients
  • Pregnancy and lactation
  • Simultaneous participation in other clinical research
  • Patients with evidence of ocular infection or inflammation
  • History of renal or hepatic impairment, hypokalemia and hyponatremia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028664


Locations
Switzerland
Clinique de Montchoisi, Centre du Glaucome
Lausanne, Switzerland, 1006
Sponsors and Collaborators
Sensimed AG
Clinique de Montchoisi, Lausanne, Switzerland
  More Information

Responsible Party: Prof. André Mermoud, Clinique de Montchoisi
ClinicalTrials.gov Identifier: NCT01028664     History of Changes
Other Study ID Numbers: 09/05
First Submitted: December 7, 2009
First Posted: December 9, 2009
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by Sensimed AG:
Glaucoma and ocular hypertension patients

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases