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

NCT01561001 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2015-05-20

No results posted yet for this study

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.

Conditions

  • Primary Open Angle Glaucoma

Interventions

DEVICE

SENSIMED Triggerfish®

Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.

Sponsors & Collaborators

  • Clinique Monchoisi

    collaborator UNKNOWN

  • Sensimed AG

    lead INDUSTRY

Principal Investigators

  • André Mermoud, MD · Clinique Monchoisi, Unité du Glaucome

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-02-28
Completion
2013-03-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01561001 on ClinicalTrials.gov