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

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. Identifier: NCT01766947
Recruitment Status : Withdrawn
First Posted : January 11, 2013
Last Update Posted : May 13, 2014
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 through the Schlemm's canal 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 (DS) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow by removing part of the inner wall of Schlemm's canal and trabecular meshwork. DS was shown to achieve a good control on IOP over the long term.

The purpose of this study is to assess the 24-hour IOP fluctuation profile recorded with Triggerfish in patients with POAG before and after DS.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Device: Sensimed Triggerfish Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Prospective, Open Label Study to Assess the 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy
Study Start Date : November 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Triggerfish
Device : Sensimed Triggerfish
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 DS 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 patient with POAG

    • Before DS
    • 3 months after DS

Secondary Outcome Measures :
  1. effect of DS on the diurnal and nocturnal IOP fluctuation pattern [ Time Frame: 3 months ]
    Diurnal and nocturnal IOP fluctuation pattern The wake/sleep and sleep/wake Triggerfish slopes Timing of Triggerfish acrophase

  2. Changes in visual field up to 6 months after DS [ Time Frame: 3 months ]
    Change in the visual field

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

Information from the National Library of Medicine

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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 DS
  • 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
  • Any other contra-indication listed in the Triggerfish user manual

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 identifier (NCT number): NCT01766947

Centre Hospitalier National d'Opthalmology des Quinze-Vingts
Paris, France, 75571
Sponsors and Collaborators
Sensimed AG
Principal Investigator: Christophe Baudouin, MD Centre hosptilatier National d'Opthalmologie des Quinze-Vingts

Responsible Party: Sensimed AG Identifier: NCT01766947     History of Changes
Other Study ID Numbers: TF-1206
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014

Keywords provided by Sensimed AG:
Deep sclerectomy

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