IOP Fluctuations in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty

Study Overview
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Brief Summary
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Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the 24-hour effect of SLT in untreated glaucoma patients. The purpose of this study is to assess the changes of IOP over a 24-hour period in patients with glaucoma undergoing SLT.

Official Title
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A Prospective, Observational, Open Label Study to Assess the 24-hour IOP Fluctuation Pattern Recorded With SENSIMED Triggerfish® in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty

Conditions
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Primary Open Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliative 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 primary open angle glaucoma (POAG) including pigmentary glaucoma or pseudoexfoliative glaucoma (PEX) Documented glaucomatous VF damage (in the previous 8 months) with mean defect (MD) > 2.5 dB No or stable anti-glaucomatous drug therapy since at least 3 months Structural and/or functional glaucomatous damage Aged more than 18 years, of either sex Not more than 6 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: Refractory glaucoma Patients having undergone ocular laser procedures or intraocular surgery for the treatment of glaucoma 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triggerfish<br>Device: Sensimed Triggerfish | Device: Sensimed Triggerfish<br>* Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the differences between the nycthemeral IOP patterns recorded with Triggerfish, during two 24-hour periods in patients with POAG, before and after SLT. | Wake-to-Sleep slopes Overall variability Diurnal and nocturnal IOP patterns Number of peaks | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess IOP patterns of POAG patients during office hours | Overall variability Diurnal and nocturnal IOP patterns Number of peaks in the study population before and after SLT | 1 month | 
| Safety and tolerability in this patient population | Adverse events and serious adverse events will be collected throughout the duration of the study | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, SLT