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

Not Applicable

Terminated

• Conditions: Primary Open Angle Glaucoma

• Registration Number: NCT01561001
• Lead Sponsor: Sensimed AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Study Start: 2012-04
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	3 months	Adverse events and serious adverse events collected throughout the duration of the study
Changes in visual field 3 months after DSCI	3 months	Change in the visual field
Effect of DSCI on the diurnal and nocturnal IOP fluctuation pattern	3 months	Diurnal and nocturnal IOP fluctuation pattern, wake/sleep and sleep/wake Triggerfish® slopes, Timing of Triggerfish® acrophase, Concomitant IOP-lowering topical drug use

Trial Locations

Locations (1)

Clinique Monchoisi, Unité du Glaucome; 🇨🇭 Lausanne, Switzerland