IOP Pattern in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After LPI

Study Overview
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Brief Summary
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The purpose of the study is to determine the relationship of the intraocular pressure patterns recorded during 2 sessions using Triggerfish, before and after elective laser peripheral iridotomy in angle closure glaucoma patients

Official Title
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A Prospective, Open Label Study Assessing the 24-hour Intraocular Pressure Pattern Monitored by SENSIMED Triggerfish® in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After Laser Peripheral Iridotomy

Conditions
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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 Angle Closure (PAC) or Primary Angle Closure Glaucoma (PACG) with indication for Laser Peripheral Iridotomy (LPI). PAC is defined by the presence of a partial or complete iridotrabecular contact(ITC) in more than 2 quadrants with either raised intraocular pressure (IOP) (ie. more than 21 mmHg) and/or PAS; however, with normal optic disc and visual field. PACG is defined by the presence of ITC with either raised IOP and/or PAS, and evidence of glaucomatous optic disc and visual field No IOP-lowering drug treatment or a 4-week wash-out period prior to Study Day 0 Aged ≥18 years, of either sex Not more than 6 diopters spherical equivalent on the study eye Have given written informed consent, prior to any investigational procedures Exclusion Criteria: History of acute angle closure glaucoma on the study eye Secondary angle closure glaucoma on the study eye History of ocular surgery within the last 3 months on the study eye History of ocular laser treatment, including previous LPI on the study eye Corneal or conjunctival abnormality precluding contact lens adaptation on the study eye Severe dry eye syndrome on the study eye 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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SENSIMED Triggerfish®<br>SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization | Device: SENSIMED Triggerfish®<br>* SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization<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 intraocular pressure patterns recorded with Triggerfish during two 24-hour periods, in patients with Primary angle closure and Primary angle closure glaucoma, before and after laser peripheral iridotomy |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the nycthemeral intraocular pressure patterns specific to primary angle closure and primary angle closure glaucoma |  | 24 hours | 
| To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern in primary angle closure and primary angle closure glaucoma |  | 24 hours |