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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01906151
• Other study ID #: TF-1306
• Status: Withdrawn
• Phase: N/A
• First received: July 19, 2013
• Last updated: May 12, 2014
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Angle-Closure

Intervention

Device:
• SENSIMED Triggerfish®
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

Locations

Country	Name	City	State
France	CHNO des Quinze-Vingts, 28 rue Charenton	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess the nycthemeral intraocular pressure patterns specific to primary angle closure and primary angle closure glaucoma		24 hours	No
Secondary	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	No