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

Primary Open Angle Glaucoma Clinical Trial

Official title:

24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy With Collagen Implant

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01561001
• Other study ID #: TF-1113
• Status: Terminated
• Phase: N/A
• First received: March 20, 2012
• Last updated: May 19, 2015
• Start date: April 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2015
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork 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 with a collagen implant (DSCI) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow. This forms the rationale to conduct this prospective, open label study to assess the 24-hour IOP fluctuation profile recorded with Triggerfish® in patients with POAG before and after DSCI.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• 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 DSCI

• 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

Study Design

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

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
Switzerland	Clinique Monchoisi, Unité du Glaucome	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Sensimed AG	Clinique Monchoisi

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of DSCI on IOP fluctuation profile as recorded by Triggerfish® in patients with POAG.	The IOP fluctuation profile will be recorded by Triggerfish® in patients with POAG; before DSCI; 3 months after DSCI.	3 months	No
Secondary	Effect of DSCI on the diurnal and nocturnal IOP fluctuation pattern	Diurnal and nocturnal IOP fluctuation pattern, wake/sleep and sleep/wake Triggerfish® slopes, Timing of Triggerfish® acrophase, Concomitant IOP-lowering topical drug use	3 months	No
Secondary	Changes in visual field 3 months after DSCI	Change in the visual field	3 months	No
Secondary	Safety and tolerability	Adverse events and serious adverse events collected throughout the duration of the study	3 months	Yes