Clinical trial NCT01766947: IOP Fluctuations in Primary Open Angle Glaucoma Patients Before and After Deep Sclerectomy
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Primary Open Angle Glaucoma
Keywords: Glaucoma
Deep sclerectomy
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2013-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.


Eligibility 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

Primary outcomes:
measure: Effect of DS on IOP fluctuation profile as recorded by Triggerfish in patients with POAG.
timeFrame: 3 months
Secondary outcomes:
measure: effect of DS on the diurnal and nocturnal IOP fluctuation pattern
timeFrame: 3 months
measure: Changes in visual field up to 6 months after DS
timeFrame: 3 months
measure: Safety and Tolerability
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier National d'Opthalmology des Quinze-Vingts
Study officials:
affiliation: Centre hosptilatier National d'Opthalmologie des Quinze-Vingts
name: Christophe Baudouin, MD
role: PRINCIPAL_INVESTIGATOR
References: