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

Primary Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01766947
• Other study ID #: TF-1206
• Status: Withdrawn
• Phase: N/A
• First received: January 10, 2013
• Last updated: May 12, 2014
• Start date: November 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Device:
• Sensimed Triggerfish
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

Locations

Country	Name	City	State
France	Centre Hospitalier National d'Opthalmology des Quinze-Vingts	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Changes in visual field up to 6 months after DS	Change in the visual field	3 months	No
Secondary	Safety and Tolerability	Adverse events and serious adverse events will be collected throughout the duration of the study	3 months	Yes