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

Not Applicable

Withdrawn

• Conditions: Primary Open Angle Glaucoma
• Interventions: Device: Sensimed Triggerfish

• Registration Number: NCT01766947
• Lead Sponsor: Sensimed AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triggerfish	Sensimed Triggerfish	Device : Sensimed Triggerfish

Primary Outcome Measures

Name	Time	Method
Effect of DS on IOP fluctuation profile as recorded by Triggerfish in patients with POAG.	3 months	The IOP fluctuation profile will be recorded by Triggerfish in patient with POAG; * Before DS; * 3 months after DS

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier National d'Opthalmology des Quinze-Vingts; 🇫🇷 Paris, France