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

NCT ID: NCT01906151

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-03-31

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

Conditions

Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

SENSIMED Triggerfish®

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sensimed AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Baudouin, MD

Role: PRINCIPAL_INVESTIGATOR

CHNO des Quinze-Vingts, 28 rue Charenton, 75571 Paris Cedex 12, France

Locations

CHNO des Quinze-Vingts, 28 rue Charenton

Paris, , France

Countries

France

Other Identifiers

TF-1306

Identifier Type: -

Identifier Source: org_study_id