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IOP Fluctuations in Primary Open Angle Glaucoma Patients Before and After Deep Sclerectomy With Collagen Implant

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ClinicalTrials.gov Identifier: NCT01561001
Recruitment Status : Terminated
First Posted : March 22, 2012
Last Update Posted : May 20, 2015
Clinique Monchoisi
Information provided by (Responsible Party):
Sensimed AG

Brief Summary:
Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork towards the systemic circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to lower IOP in order to prevent progression of the optic neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses despite controlled IOP, surgery may be indicated. Deep sclerectomy with a collagen implant (DSCI) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow. This forms the rationale to conduct this prospective, open label study to assess the 24-hour IOP fluctuation profile recorded with Triggerfish® in patients with POAG before and after DSCI.

Condition or disease Intervention/treatment
Primary Open Angle Glaucoma Device: SENSIMED Triggerfish®

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy With Collagen Implant
Study Start Date : April 2012
Primary Completion Date : February 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Intervention Details:
    Device: SENSIMED Triggerfish®
    Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.

Primary Outcome Measures :
  1. Effect of DSCI on IOP fluctuation profile as recorded by Triggerfish® in patients with POAG. [ Time Frame: 3 months ]

    The IOP fluctuation profile will be recorded by Triggerfish® in patients with POAG

    • before DSCI
    • 3 months after DSCI.

Secondary Outcome Measures :
  1. Effect of DSCI on the diurnal and nocturnal IOP fluctuation pattern [ Time Frame: 3 months ]
    Diurnal and nocturnal IOP fluctuation pattern, wake/sleep and sleep/wake Triggerfish® slopes, Timing of Triggerfish® acrophase, Concomitant IOP-lowering topical drug use

  2. Changes in visual field 3 months after DSCI [ Time Frame: 3 months ]
    Change in the visual field

  3. Safety and tolerability [ Time Frame: 3 months ]
    Adverse events and serious adverse events collected throughout the duration of the study

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of POAG
  • Documented glaucomatous VF damage with mean defect (MD) > 3 dB
  • Progressing glaucomatous damage justifying a DSCI
  • Aged ≥18 years, of either sex
  • Not more than 4 diopters spherical equivalent on the study eye
  • Not more than 2 diopters cylinder equivalent on the study eye
  • Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

  • Corneal or conjunctival abnormality precluding contact lens adaptation
  • Severe dry eye syndrome
  • Patients with allergy to corneal anesthetic
  • Patients with contraindications for silicone contact lens wear
  • Patients not able to understand the character and individual consequences of the investigation
  • Participation in other clinical research within the last 4 weeks

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): NCT01561001

Clinique Monchoisi, Unité du Glaucome
Lausanne, Switzerland, 1006
Sponsors and Collaborators
Sensimed AG
Clinique Monchoisi
Principal Investigator: André Mermoud, MD Clinique Monchoisi, Unité du Glaucome

Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01561001     History of Changes
Other Study ID Numbers: TF-1113
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases