NCT01766947

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sensimed AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Sensimed Triggerfish	Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-01-11
• Last updated: 2014-05-13

Locations

1 site across 1 country: France