Primary Open Angle Glaucoma
Conditions
Keywords
Glaucoma, Deep sclerectomy
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.
Interventions
DEVICESensimed Triggerfish
Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
Sponsors
Sensimed AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
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 * Any other contra-indication listed in the Triggerfish user manual
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of DS on IOP fluctuation profile as recorded by Triggerfish in patients with POAG. | 3 months | The IOP fluctuation profile will be recorded by Triggerfish in patient with POAG * Before DS * 3 months after DS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effect of DS on the diurnal and nocturnal IOP fluctuation pattern | 3 months | Diurnal and nocturnal IOP fluctuation pattern The wake/sleep and sleep/wake Triggerfish slopes Timing of Triggerfish acrophase |
| Changes in visual field up to 6 months after DS | 3 months | Change in the visual field |
| Safety and Tolerability | 3 months | Adverse events and serious adverse events will be collected throughout the duration of the study |
Countries
France
Outcome results
None listed