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

This study has been terminated.
Sponsor:
Collaborator:
Clinique Monchoisi
Information provided by (Responsible Party):
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01561001
First received: March 20, 2012
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 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
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

Resource links provided by NLM:


Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • Effect of DSCI 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 patients with POAG

    • before DSCI
    • 3 months after DSCI.


Secondary Outcome Measures:
  • Effect of DSCI on the diurnal and nocturnal IOP fluctuation pattern [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Diurnal and nocturnal IOP fluctuation pattern, wake/sleep and sleep/wake Triggerfish® slopes, Timing of Triggerfish® acrophase, Concomitant IOP-lowering topical drug use

  • Changes in visual field 3 months after DSCI [ 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 collected throughout the duration of the study


Enrollment: 3
Study Start Date: April 2012
Estimated Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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 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
  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: NCT01561001

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

No publications provided

Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01561001     History of Changes
Other Study ID Numbers: TF-1113
Study First Received: March 20, 2012
Last Updated: February 20, 2013
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on September 18, 2014