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

Sensimed AG1 site in 1 country27 target enrollmentJuly 2013

ConditionsGlaucoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Glaucoma
Sponsor: Sensimed AG
Enrollment: 27
Locations: 1
Primary Endpoint: The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

July 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sensimed AG

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma

Time Frame: 24 hours

Secondary Outcomes

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)