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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Device: Sensimed Triggerfish

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75571
    • Centre Hospitalier National d'Opthalmology des Quinze-Vingts

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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of DS on the diurnal and nocturnal IOP fluctuation pattern	Diurnal and nocturnal IOP fluctuation pattern The wake/sleep and sleep/wake Triggerfish slopes Timing of Triggerfish acrophase	3 months
Changes in visual field up to 6 months after DS	Change in the visual field	3 months
Safety and Tolerability	Adverse events and serious adverse events will be collected throughout the duration of the study	3 months

Collaborators and Investigators

• Sponsor: Sensimed AG
• Investigators: Principal Investigator: Christophe Baudouin, MD, Centre hosptilatier National d'Opthalmologie des Quinze-Vingts

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: January 10, 2013
• First Submitted That Met QC Criteria: January 10, 2013
• First Posted (Estimate): January 11, 2013

Study Record Updates

• Last Update Posted (Estimate): May 13, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Glaucoma; Deep sclerectomy
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: TF-1206