Clinical trial NCT01906151: IOP Pattern in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After LPI
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glaucoma
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2013-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 24 hours
Secondary outcomes:
measure: To assess the nycthemeral intraocular pressure patterns specific to primary angle closure and primary angle closure glaucoma
timeFrame: 24 hours
measure: To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern in primary angle closure and primary angle closure glaucoma
timeFrame: 24 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: CHNO des Quinze-Vingts, 28 rue Charenton
Study officials:
affiliation: CHNO des Quinze-Vingts, 28 rue Charenton, 75571 Paris Cedex 12, France
name: Christophe Baudouin, MD
role: PRINCIPAL_INVESTIGATOR
References: