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

NCT01561001 | Terminated

• 1 other identifier: TF-1113
• Study Type: interventional
• Target: 3
• 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 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Effect of DSCI on the diurnal and nocturnal IOP fluctuation pattern

  3 months

• Changes in visual field 3 months after DSCI

  3 months

• Safety and tolerability

  3 months

Interventions

SENSIMED Triggerfish® DEVICE

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

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 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

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

Sponsors & Collaborators

• Sensimed AG: lead
• Clinique Monchoisi: collaborator

Study Sites (1)

Clinique Monchoisi, Unité du Glaucome

Lausanne, 1006, Switzerland

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• André Mermoud, MD

  Clinique Monchoisi, Unité du Glaucome

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

CH (1)