An Open Label Study Assessing the 24-hour Intraocular Pressure Pattern in PAC and PACG Patients, Before and After Laser Peripheral Iridotomy

Study Overview
=================
Brief Summary
-----------------
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
-----------------
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
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: SENSIMED Triggerfish®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary angle closure (PAC) or primary angle closure glaucoma (PACG) with indication for laser peripheral iridotomy (PAC is defined by the presence of a partial or complete iridotrabecular contact in more than 2 quadrants with either raised intraocular pressure [i.e. more than 21 mmHg] and/or primary adhesion to the trabecular meshwork (peripheral anterior synechiae [PAS]; however, with normal optic disc and visual field. PACG is defined by the presence of iridotrabecular contact with either raised intraocular pressure and/or PAS, and evidence of glaucomatous optic disc and visual field) No intraocular pressure-lowering drug treatment or a 4-week wash-out period prior to study day 0 and throughout the study Aged ≥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 procedure Exclusion Criteria: History of acute angle closure glaucoma Secondary angle closure glaucoma History of ocular surgery within the last 3 months History of ocular laser treatment, including previous laser peripheral iridotomy 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish | Device: SENSIMED Triggerfish®<br>* All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the nycthemeral Intraocular pressure patterns specific to PAC and PACG |  | 24 hours | 
| To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern for each group of patients |  | 24 hours | 
| To assess the comfort of contact lens sensor wear in patients of Indian origin |  | 24 hours |