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

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

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.

Study Overview

• Status: Terminated
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Device: SENSIMED Triggerfish®

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1006
    • Clinique Monchoisi, Unité du Glaucome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of DSCI on IOP fluctuation profile as recorded by Triggerfish® in patients with POAG.	The IOP fluctuation profile will be recorded by Triggerfish® in patients with POAG; before DSCI; 3 months after DSCI.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of DSCI on the diurnal and nocturnal IOP fluctuation pattern	Diurnal and nocturnal IOP fluctuation pattern, wake/sleep and sleep/wake Triggerfish® slopes, Timing of Triggerfish® acrophase, Concomitant IOP-lowering topical drug use	3 months
Changes in visual field 3 months after DSCI	Change in the visual field	3 months
Safety and tolerability	Adverse events and serious adverse events collected throughout the duration of the study	3 months

Collaborators and Investigators

• Sponsor: Sensimed AG
• Collaborators: Clinique Monchoisi
• Investigators: Principal Investigator: André Mermoud, MD, Clinique Monchoisi, Unité du Glaucome

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 20, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: TF-1113