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

Sensimed

Status

Terminated

Conditions

Primary Open Angle Glaucoma

Treatments

Device: SENSIMED Triggerfish®

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01561001

TF-1113

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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