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

NCT01906151 — Not applicable, Withdrawn, Sensimed AG

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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

Registry	NCT01906151
Status	Withdrawn
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Sponsor	Sensimed AG (Industry)
Conditions	Glaucoma
Interventions	SENSIMED Triggerfish® (Device)
Dates	start 2014-01-01, primary completion 2014-03-01, completion 2014-03-01, first posted 2013-07-23, last updated 2014-05-13
Locations	1 site in France

-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

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+Arms and interventions

Arm	Type	Interventions	Description
SENSIMED Triggerfish®	Other	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

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

+Outcome measures

Primary outcomes

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

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]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
CHNO des Quinze-Vingts, 28 rue Charenton	Paris	France

+Investigators

Christophe Baudouin, MD, Principal investigator, CHNO des Quinze-Vingts, 28 rue Charenton, 75571 Paris Cedex 12, France