Use of an Ocular Telemetry Sensor in Diamox Treated Patients

This study has been completed.
Sponsor:
Collaborator:
Clinique de Montchoisi, Lausanne, Switzerland
Information provided by:
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01028664
First received: December 7, 2009
Last updated: December 2, 2010
Last verified: December 2010
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028664

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

No publications provided

Responsible Party: Prof. André Mermoud, Clinique de Montchoisi
ClinicalTrials.gov Identifier: NCT01028664     History of Changes
Other Study ID Numbers: 09/05
Study First Received: December 7, 2009
Last Updated: December 2, 2010
Health Authority: Switzerland: Commission cantonale d'éthique de la recherche sur l'être humain

Keywords provided by Sensimed AG:
Glaucoma and ocular hypertension patients

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

ClinicalTrials.gov processed this record on August 21, 2014