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

NCT01766947 | Withdrawn

• 1 other identifier: TF-1206
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Glaucoma; Deep sclerectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• effect of DS on the diurnal and nocturnal IOP fluctuation pattern

  3 months

• Changes in visual field up to 6 months after DS

  3 months

• Safety and Tolerability

  3 months

Study Arms (1)

Triggerfish

EXPERIMENTAL

Device : Sensimed Triggerfish

Device: Sensimed Triggerfish

Interventions

Sensimed Triggerfish DEVICE

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

Triggerfish

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensimed AG: lead

Study Sites (1)

Centre Hospitalier National d'Opthalmology des Quinze-Vingts

Paris, 75571, France

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Christophe Baudouin, MD

  Centre hosptilatier National d'Opthalmologie des Quinze-Vingts

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 11, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

FR (1)