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

NCT01766947 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-05-13

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 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.

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

  • Sensimed AG

    lead INDUSTRY

Principal Investigators

  • Christophe Baudouin, MD · Centre hosptilatier National d'Opthalmologie des Quinze-Vingts

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • France

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 NCT01766947 on ClinicalTrials.gov