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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01766947
First received: January 10, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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 Intervention
Primary Open Angle Glaucoma
Device: Sensimed Triggerfish

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • Effect of DS on IOP fluctuation profile as recorded by Triggerfish in patients with POAG. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

    • Before DS
    • 3 months after DS


Secondary Outcome Measures:
  • effect of DS on the diurnal and nocturnal IOP fluctuation pattern [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Diurnal and nocturnal IOP fluctuation pattern The wake/sleep and sleep/wake Triggerfish slopes Timing of Triggerfish acrophase

  • Changes in visual field up to 6 months after DS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in the visual field

  • Safety and Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Adverse events and serious adverse events will be collected throughout the duration of the study


Enrollment: 0
Study Start Date: November 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01766947

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

No publications provided

Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01766947     History of Changes
Other Study ID Numbers: TF-1206
Study First Received: January 10, 2013
Last Updated: May 12, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sensimed AG:
Glaucoma
Deep sclerectomy

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

ClinicalTrials.gov processed this record on July 28, 2014