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

Study Overview
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Brief Summary
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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.

Official Title
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24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy With Collagen Implant

Conditions
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Primary Open Angle Glaucoma

Intervention / Treatment
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* Device: SENSIMED Triggerfish®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SENSIMED Triggerfish®|Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of DSCI on the diurnal and nocturnal IOP fluctuation pattern | Diurnal and nocturnal IOP fluctuation pattern, wake/sleep and sleep/wake Triggerfish® slopes, Timing of Triggerfish® acrophase, Concomitant IOP-lowering topical drug use | 3 months | 
| Changes in visual field 3 months after DSCI | Change in the visual field | 3 months | 
| Safety and tolerability | Adverse events and serious adverse events collected throughout the duration of the study | 3 months |