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

NCT01906151 | Withdrawn

• 1 other identifier: TF-1306
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• To assess the nycthemeral intraocular pressure patterns specific to primary angle closure and primary angle closure glaucoma

  24 hours

• 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

Study Arms (1)

SENSIMED Triggerfish®

OTHER

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

Device: SENSIMED Triggerfish®

Interventions

SENSIMED Triggerfish® 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

SENSIMED Triggerfish®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensimed AG: lead

Study Sites (1)

CHNO des Quinze-Vingts, 28 rue Charenton

Paris, 75571, France

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Christophe Baudouin, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 23, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

FR (1)